Interventional News Issue 84—December 2021 US Edition

December 2021 | Issue 84

Featured in this issue:

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13

Thromboaspiration: More options for pulmonary embolism

Cryoablation: Freezing out lumpectomy

page 8

E

In the trial, radioembolization (also called selective internal radiation therapy [SIRT] or sometimes transarterial radioembolization [TARE]) using glass beads (TheraSphere; Boston Scientific) containing radioactive yttrium-90 (Y-90) was used as a secondline treatment in combination with standard of care systemic chemotherapy for patients who had disease progression during or after first-line chemotherapy.

p<0.01 p=0.02 At one month, embolization significantly reduced pain more than the sham treatment did (p<0.01)

mbolization, which is rapidly surfacing as a safe and effective procedure for the treatment of patients with osteoarthritis of the knee, has been shown to be technically achievable, with very promising outcomes at early follow-up. It is thought to bring down pain by reducing synovial arterial hypervascularity.

A multicentre, randomised, single-blinded, shamcontrolled study published online ahead of print in October 2021 in the Journal of Vascular and Interventional Radiology (JVIR) showed that, in patients with mild-to-moderate knee osteoarthritis, embolization results in symptomatic improvement greater than the sham procedure did, with clinically significant reduction in pain and disability (as measured by the Visual Analogue Score [VAS] and Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]). In the 21-patient study, all those assigned to the sham group failed to show significant improvements at one month and crossed over to the treatment arm.

“Genicular artery embolization has the potential to be one of the most Ari J Isaacson commonly performed embolization

page 18

EPOCH trial reignites radioembolization as treatment for colorectal liver metastases

Embolization comes knocking on knee pain’s door

A wealth of data emerging in the last 18 months, including from a small multicentre, randomised, sham-controlled study of genicular artery embolization for knee pain secondary to osteoarthritis, brings in its slipstream a glimpse of other similar minimally invasive options to treat disability in the entire musculoskeletal system.

Profile: Laura Crocetti

Disability improvement was also significantly greater in the treatment group (p=0.02)

procedures for interventional radiologists in the near future and make a substantial impact in the lives of millions of patients. The data from our study demonstrate that the effect of embolization in reducing pain and improving function is far greater than the effect of a sham procedure or placebo. This study will be useful in convincing potential referrers as well as insurance companies that this procedure should be part of the osteoarthritic knee pain treatment algorithm. What is most exciting is that this procedure may just be the first of many different embolization procedures that will be utilised to treat pain throughout the musculoskeletal system,” Ari J Isaacson, adjunct faculty at the University of North

THE EPOCH TRIALISTS, THEREFORE, set their sights on determining the impact of radioembolization and second-line chemotherapy in patients with colorectal liver metastases who progressed on oxaliplatinor irinotecan-based first-line therapy.

The international, prospective phase 3 EPOCH pivotal clinical trial randomised 428 patients.

Findings from the trial, which were presented at the European Society for Medical Oncology (ESMO) congress (16–21 September 2021) and published in the Journal of Clinical Oncology, showed that the addition of SIRT met both its primary endpoints, including progression-free survival (PFS) and hepatic progression-free survival (hPFS) of patients with metastatic colorectal cancer (mCRC) of the liver. The trial did not show significant improvement in overall survival of the patients in the SIRT arm.

The addition of TheraSphere treatment significantly increased both PFS (p=0.0013) and hPFS (p<0.0001). Patients receiving SIRT with second-line chemotherapy were 31% less likely to show disease progression or death (hazard ratio [HR]=0.69) and 41% less likely to show hepatic disease progression or death vs. with chemotherapy alone (HR=0.59). Median overall survival was 14 and 14.4 months (p=0.7229). There were 68.4% grade 3 adverse events reported after radioembolization as compared with 49.3% in those who received chemotherapy alone. Both groups received the Continued on page 2

Continued on page 4

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December 2021 | Issue 84

Interventional Oncology

EPOCH trial reignites radioembolization as treatment for colorectal liver metastases Continued from page 1

full chemotherapy dose intensity.

Riad Salem (Northwestern Memorial Hospital, Chicago, USA) and co-principal investigator of the trial, said: “The EPOCH trial not only demonstrated positive safety and efficacy data for the patients treated in this study, but underscores the success of integrating a devicebased therapy like TheraSphere treatment in the continuum of care with systemic chemotherapy and biologic regimens, thereby providing the rationale and setting the stage for future Riad investigation in other cancer types.”

Salem EPOCH is being hailed as the first positive phase 3 SIRT trial in any disease setting. The data are expected to support Boston Scientific’s regulatory submission to the US Food and Drug Administration (FDA). In the conclusion of the published article, the authors write: “Further subset analyses are needed to better define the ideal patient population that would benefit from radioembolization.”

A previous phase 3 trial, SIRFLOX, that used a different resinY-90 microsphere platform (SIR-Spheres; Sirtex/China Grand Pharmaceutical and Healthcare Holdings) failed to show significant additive benefits to chemotherapy as measured by progression-free survival at

TheraSphere treatment significantly increased PFS

any site (but significantly delayed disease progression in the liver). The trial also did not find a benefit for additive SIRT when it came to overall survival in a first-line setting. These results and subsequent analyses including a pooled analysis of SIRFLOX-FOXFIRE-FOXFIRE global, which reported some encouraging data for patients with respect to progression in the liver, still did not reveal significant benefits with respect to overall survival.

Commenting on the EPOCH trial results, Mary

News in brief

The latest stories from the interventional world

n GLOBAL OUTREACH Janice Newsome (Atlanta, USA considers herself “a little bit of a global citizen”. “As interventional radiologists, we believe deeply in what we do, every single day—fundamentally, that it improves the health of the patients we treat. And if I believe that, it is only one step further away to see that good healthcare should be available to everyone, everywhere.”

For more on this story go to page 11.

Peter Littler

n NEW FIVE-YEAR DATA FOR ENDOAVF: The Ellipsys vascular access system (Avenu Medical/Medtronic) can be used to easily and safely create durable percutaneous arteriovenous fistulas (pAVFs) for haemodialysis—with new, long-term data suggesting it offers an “excellent alternative” to surgical creation in end-stage renal disease (ESRD) patients. That is according to Jeffrey Hull (Richmond, USA) who presented five-year results from the Ellipsys US pivotal trial at this year’s American Society of Nephrology (ASN) Kidney Week (2–7 November 2021, virtual).

Further subset analyses are needed to better define the ideal patient population that would benefit from radioembolization.”

Mulcahy, medical oncologist at Northwestern Memorial Hospital and coprincipal investigator of the trial, noted: “In the second line of therapy for metastatic colorectal cancer, with disease isolated to the liver, the addition of TheraSphere with chemotherapy resulted in a significant delay in overall tumour progression. Additionally, chemotherapy-related adverse events were comparable between the trial arms.”

Peter Littler (Freeman Hospital, Newcastle, UK) is the 2021 British Society of Interventional Radiology (BSIR) Scientific Programme Committee chair and has a specialist interest in interventional oncology.

Speaking broadly on the availability of SIRT in the UK for this patient group, he says: “This study adds important information to existing literature in the area.

SIRT availability in the UK for patients with colorectal metastases is limited to small numbers in the palliative setting in relatively few commissioned NHS (National Health Service) centres. Positive phase 3 data in this patient group should inform further evaluation of the technology, enabling greater access to SIRT for more of our patients.”

For more on this story go to page 21. n AORTIC UPDATES: As evidence builds on the importance of reducing the risk of stroke by removing residual air prior to thoracic endovascular aortic repair (TEVAR) procedures, the onus will be on surgeons and device manufacturers to minimise this risk, discussion at CX Aortic Vienna 2021 (5–7 October, broadcast) revealed.

This session also focused on findings from the Stroke from thoracic endovascular procedures (STEP) study, and featured a first-to-podium presentation highlighting the benefits of carbon dioxide compared to standard saline flushing after TEVAR.

For more on this story go to page 22.

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December 2021 | Issue 84

Embolization

Embolization comes knocking on knee pain’s door Continued from page 1

Carolina at Chapel Hill School of Medicine, Chapel Hill, USA, and one of the researchers on the sham trial, tells Interventional News.

These investigators further reported statistically significant greater pain reduction captured by VAS in the treatment group when compared to those undergoing the sham treatment at one month (p<0.01). Disability improvement was also significantly greater in the treatment group (p=0.02).

“Genicular artery embolization has given many of my patients, some of whom have previously given up trying to control their pain, new opportunities to live more fulfilling lives. Often, these patients do not respond to conservative management, but are precluded by their comorbidities from having a knee replacement. Embolization can be performed with permanent particles, which have been shown to be safe, or temporary agents such as an imipenem/cilastatin slurry. The embolization technique itself is also constantly evolving to become safer and more effective.

Examples include using ice packs on the skin, which have significantly decreased the rates of cutaneous nontarget embolization that results in skin ulcerations. I am very excited about recent publications and important upcoming studies. While we do not yet fully understand the mechanism of action of this treatment, I believe that existing data show already that we have the ability to help many patients,” says Yilun Koethe, Oregon Health and Science University, Portland, USA. Another recent publication that set out to evaluate the safety and efficacy of embolization for the treatment of symptomatic knee osteoarthritis found the procedure to be “effective and durable in reducing pain symptoms from moderate or severe knee osteoarthritis that is refractory to other conservative therapy, with an acceptable safety profile.”

Siddarth A Padia (Division of Interventional Radiology, Department of Radiology, David Geffen School of Medicine at University of California Los Angeles, Los Angeles, USA) and colleagues write that in their 40-patients study, the WOMAC total and VAS pain scores decreased by 61% and 67% at 12 months from a median baseline of 52 (of 96) and 8 (of 10), respectively.

Sixty-eight per cent of patients had a reduction of ≥50% in both WOMAC total and VAS pain scores.

The prospective, single-centre, open-label US Food and Drug Administration-approved investigational device exemption study was published in October 2021 in the Journal of Bone & Joint Surgery.

Padia and colleagues pointed to transient skin discolouration and transient mild knee pain after the procedure being “common and expected”. Treatmentrelated adverse events included a groin haematoma requiring overnight observation, self-resolving focal skin ulceration, and an asymptomatic small bone infarct on magnetic resonance imaging (MRI) at three months.

“Other than total knee arthroplasty, treatments for knee osteoarthritis have been limited in effect and duration. Research over the past several decades has failed to improve treatment options for this common ailment. Genicular artery embolization looks to be a promising breakthrough therapy for symptomatic knee osteoarthritis. Our trial showed that embolization demonstrated a marked reduction in pain and improvement in function in 68% of study participants, with minimal adverse events. Moreover, the duration of effect was seen to at least one year. These results will serve as a platform for a large-scale randomised trial, which will hopefully begin in 2022,” Padia told this newspaper.

If the evidence-base carries on being augmented for genicular artery embolization, experts believe that its impact can be widespread. “Knee pain from arthritis affects many people of different backgrounds, genders, ethnicities and ages. Embolization has the potential to improve the lives of different kinds of patients all over the world,” Theresa Caridi, University of Alabama at Birmingham, Birmingham, USA, contends.

Mark Little, University Department of Radiology, Royal Berkshire NHS Foundation Trust, Reading, UK, commented: “Over the last 18 months, there has been increasing amounts of data within the literature. All studies have reported consistent results; embolization is a safe and potentially effective treatment for patients with osteoarthritis of the knee. The recent study that randomised 21 patients to receive genicular artery embolization or a sham procedure was the first paper to address the placebo effect. Our own interim data from the GENESIS study, which was published in

CardioVascular and Interventional Radiology in January 2021, revealed a significant improvement in pain and function at one-year follow-up, in addition to an improvement in synovitis on contrast-enhanced MRI. Embolization for this indication clearly has the potential to offer a unique, minimally invasive treatment to the millions of patients with symptomatic knee osteoarthritis, which could change the way in which we treat the disease! More data are needed to study the long-term outcomes of the procedure, the health economics associated with it, and the ideal embolic agent. Further randomised controlled studies are warranted comparing it to a sham procedure, and best medical therapy, in order to improve data generalisability. My group is extremely excited to commence recruitment for GENESIS II, a large randomised, sham-controlled trial for genicular artery embolization at the beginning of 2022. The future seems vibrant for this procedure.”

What the experts say:

Often, these patients do not respond to conservative management, but are precluded [...] from having a total knee replacement.”

Other than total knee arthroplasty, osteoarthritis treatments have been limited in effect and duration.”

Further randomised trials are warranted comparing it to a sham procedure and best medical therapy.”

Embolization has the potential to improve the lives of different kinds of patients, all over the world.”

Yilun Koethe

Mark Little

Siddharth A Padia

Theresa Caridi

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December 2021 | Issue 84

Research Findings

Prevalent, invisible conflict of interest places US IR research results on trial

Interventional radiology (IR) is regularly characterised as being “a hotbed of innovation”, but the first study to directly evaluate the level of agreement between disclosed financial relationships and open payment data for top-cited image-guided procedures in the USA lays bare that 97% of the studied authors failed to disclose at least one active financial relationship.

Importantly, declaring an interest does not equate to resolving potential bias, note authors Lee J Hsieh (University of California San Diego, San Diego, USA) and Mina S Makary (The Ohio State University Medical Center, Columbus, USA). Their research, published online ahead of print in October 2021 in the Journal of Vascular and Interventional Radiology also reignites the debate around how to weed out bias without bedevilling and stifling innovation. Interventional News speaks to the authors of the study to drill down on its findings and implications.

How should the findings of this study influence interventional radiologists to scrutinise published data?

The significance of this work is that it is the first study which directly evaluates the prevalence of conflict of interest (COI) disclosures in US-based IR research while evaluating the level of agreement between disclosed financial relationships and open payment data for top-cited image-guided procedure research.

Findings from this work should raise the attention of interventional radiologists evaluating published data to this often invisible factor that creates a risk of bias. For example, studies have shown that those with industry sponsorships are more likely to have pro-industry conclusions, and others may publish conclusions inconsistent with the study results. Industry sponsorships may also erode academic freedom and influence research agendas, inadvertently suppressing research that does not further industry’s objectives in science or policy. This potential for bias is the reason expert consensus has emphasised the importance of COI disclosure to help mitigate any potential bias and support data integrity.

What were the leading results from your data?

One of the most interesting findings was that among the 396 authors of 100 US-based, top-cited image-guided procedure publications, 97% failed to disclose at least one active financial relationship, with an average of US$57,937 in undisclosed payments per publication.

For comparison, previous studies in other areas of healthcare have found discrepancies in 43–69% of publications, while still others have reported a median rate as high as 81%. Together these trends suggest that conflicts of interest are prevalent in IR, like other areas of healthcare research, and conflicts of interest in top-cited image-guided procedure research are often underreported.

A 30% positive COI rate that climbs to 50% in standards of practice and device-related publications—what needs to be done to help recast these numbers?

To improve disclosure, authors and organisations have advocated for further development and use of open

disclosure databases, building upon the successful implementation of ClinicalTrials.gov. Many have noted that relying primarily on self-disclosure is limited and that people may overlook potential biases in themselves that they would otherwise perceive in others. Even authors who are transparent with their COIs may falsely equate disclosure with resolution, assuming that once a potential bias is disclosed, no further action is required. As such,

Even authors who are transparent with their conflicts of interest may falsely equate disclosure with resolution, assuming that once a potential bias is disclosed, no further action is required.”

Lee J Hsieh

the Committee on Publication Ethics described the importance of a shared responsibility between authors to disclose as well as journal editors to screen for and minimise potential bias. Accurate and complete disclosures may improve author transparency and public trust, One of the most but a more comprehensive approach interesting findings was involving public effort, policy that among the change, and institutional support may be needed to address the underlying issues of COIs.

396 AUTHORS

100 US-based, top-cited image-guided procedure publications,

97% failed to disclose at least one active financial relationship

What are the limitations of this dataset? How globally applicable is it?

This work had several limitations.

The prevalence of positive COIs in IR was estimated from a single volume of a single IR journal, which reflects only a fraction of a broader body of IR literature. COI disclosures may vary over time and across different journals. The assessment of agreement between disclosed financial relationships and open payment data was limited to studies published after the enactment of the Sunshine Act in August 2013. Since non-domestic financial data are difficult to obtain, only those of US authors were analysed. These all limit the generalisability and external validity of the results, particularly in the global arena.

How do you propose preparing a change?

While relationships between clinicians and industry can have many positive effects, these relationships nevertheless do create a risk of bias that must be mitigated to support the integrity of research. Our collective efforts are necessary to better understand how best to encourage disclosure and reduce bias without stifling innovation, a hallmark of our specialty.

Mina S Makary

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December 2021 | Issue 84

Bloodless Thrombectomy

VENOUS

Six-month interim registry data unlock early thrombectomy safety in pulmonary embolism patients Inari Medical has announced positive acute and long-term interim results from the first 500 pulmonary embolism patients enrolled in the FlowTriever outcomes registry (FLASH).

A

press release reports that at 48 hours post procedure, the major adverse event rate and mortality rate were low, at 1.4% and 0.2%, respectively. None of the deaths or major adverse events were device related. Collectively, these pulmonary embolism patients experienced substantial on-table improvements in haemodynamics and symptoms, which translated to six-month improvements in cardiac function, functional status, and quality of life measures.

The outcomes were achieved while limiting utilisation of hospital resources, the release adds, with less than 4% of patients receiving adjunctive therapy and a median of zero days in the intensive care unit (ICU) post procedure.

Speaking to Interventional News regarding the growing interest in mechanical thromboaspiration in the treatment of pulmonary embolism patients, Narayan Karunanithy, a consultant interventional radiologist, Guy’s & St Thomas’ NHS Foundation Trust, London, UK, said: “The catheter-based interventional treatments available to treat acute pulmonary embolism have expanded beyond catheter-directed thrombolysis recently to include several percutaneous mechanical thromboaspiration devices. Potential benefits of the latter include the use of the devices in patients with high bleeding risk, when rapid restoration of perfusion to offload the right ventricle is required in high-risk pulmonary embolism and as an alternative to surgical embolectomy in patients with multiple comorbidities.

This potentially allows a larger cohort of patients with severe pulmonary embolism to be safely treated.

However, at present, there is a lack of robust evidence for these devices demonstrating benefit over standard

care. The big research questions are whether high- and intermediaterisk pulmonary embolism patients treated with mechanical thromboaspiration achieve better immediate and longterm outcomes than those Narayan Karunanithy managed with standard care anticoagulation and whether the use of the devices is safe. The field is evolving rapidly and in the next few years we are likely to see large-scale studies answer these questions.”

FLASH is a prospective, multicentre, single-arm registry evaluating real-world patient outcomes after treatment of pulmonary embolism with FlowTriever.

The 500-patient interim results were presented on 27 October via webcast at Transcatheter Cardiovascular Therapeutics (TCT) 2021 by principal investigator Catalin Toma (University of Pittsburgh Medical Center, Pittsburgh, USA. “These interim results reinforce the strong safety profile of the FlowTriever system in real-world pulmonary embolism patients, with substantial on-table clinical improvements and immediate symptom relief,” said Toma, who added: “We believe these six-month follow-up data suggest that removal of clot burden

PAD

Head-to-head trial shows superiority of FemoSeal over ProGlide for peripheral interventions Results of the randomised, prospective, multicentre STEP trial show that the FemoSeal vascular closure system (Terumo) is superior to the Perclose ProGlide suture-mediated closure system (Abbott) in peripheral arterial disease (PAD) patients in terms of technical success using a retrograde femoral puncture. Bahaa Nasr (Brest University Hospital, Best, France) presented the latebreaking data at Paris Vascular Insights (PVI) 2021 (21–23 October, Paris, France), concluding that FemoSeal should be used in PAD patients undergoing lower limb arterial endovascular treatment, especially if they are discharged on the same day as their surgery.

ACCORDING TO NASR, MANY studies have compared vascular closure devices (VCDs) for the coronary arteries, while none have compared them for PAD. “We all know that the efficacy of a VCD is different for PAD patients because of the plaque nature in the

common femoral artery,” he remarked.

In order to assess this gap in the literature, Nasr and colleagues initiated the STEP trial. “The aim of the study was to perform a direct, head-to-head comparison between ProGlide and FemoSeal,” he relayed, explaining

without the risks of lytics has potential positive longterm implications for pulmonary embolism patients, including strikingly low rates of hospital readmissions, dyspnoea, CTED (chronic thromboembolic disease), and CTEPH (chronic thromboembolic pulmonary hypertension). These data suggest that treatment with FlowTriever may fundamentally improve the natural course of the disease, and that is tremendously exciting.”

In October, Inari Medical also announced planned enrolment in the PEERLESS trial, a new randomised controlled trial comparing the clinical outcomes of patients with intermediate-high risk pulmonary embolism treated with the FlowTriever System versus catheter-directed thrombolysis.

PEERLESS is a prospective, multicentre trial that will include up to 700 patients enrolled in 60 centres in the USA and Europe. The study consists of a primary randomisation cohort of 550 patients, and for patients who cannot be randomised due to an absolute contraindication to thrombolytics, a secondary nonrandomised cohort of up to 150 patients.

The primary outcome for the trial is a hierarchical composite of outcomes including all-cause mortality, major bleeding events, clinical deterioration and/or bailout, and length of stay in the intensive care unit.

“Historically, due to the major bleeding associated with lytic therapy, physicians needed to carefully weigh a patient’s risk of death against the risk of intervention, reserving advanced treatment for only the sickest of pulmonary embolism patients,” said global co-principal investigator, Carin Gonsalves (co-director, Division of Interventional Radiology, Thomas Jefferson University Hospitals, Philadelphia, USA). “By offering patients immediate symptom relief upon removal of significant clot burden without the risks of lytics, the potential for bloodless thrombectomy with the FlowTriever system has fundamentally altered the pulmonary embolism treatment landscape, FlowTriever challenging physicians to rethink risk stratification and the goals of intervention.” system

that the FemoSeal is a double polymer resorbable disc, while the ProGlide involves a direct suture in the artery.

He noted that the primary endpoint was VCD technical success, assessed five hours postprocedure, and defined as either haemostasis without the need for either an additional VCD or manual compression, or a drop in haemoglobin.

Patients were included in the study if they had received endovascular treatment for PAD with the use of a 5–7Fr sheath, Nasr informed the PVI audience. He added that patients who had undergone previous ipsilateral open repair of the common femoral artery, previous stenting at the puncture site, or had either radial, brachial or antegrade femoral punctures were excluded.

Nasr relayed that all patients were treated with a duplex scanguided, retrograde common femoral artery puncture. He detailed that the resumption of ambulation was assessed five hours after the procedure and that all the investigators were certified and

trained for both VCDs. A total of 230 patients were randomised, with 109 patients undergoing treatment with the assigned device in each group. According to Nasr, the baseline clinical and demographic characteristics were well balanced between the two groups. The presenter highlighted the fact that most of the patients included in the study had intermittent claudication—86% in the FemoSeal group and 85% in the ProGlide group.

The majority of the procedures were performed under local anaesthesia and the most commonly-used sheath was 6Fr in diameter, Nasr told PVI delegates. He added that there were no differences in intraoperative antithrombotic regimens, and in fact the only difference between the two groups was the need for a compression dressing, which was higher in the ProGlide group.

Nasr reported that the intention-totreat analysis showed an 80% technical success rate in the FemoSeal group,

Issue 84 | December 2021

Pulmonary Embolism

VENOUS

Thrombolex announces “very exciting” interim RESCUE results

Thrombolex recently announced the results of the RESCUE trial’s prespecified interim analysis, of the first 62 evaluable patients, in a late-breaking clinical trials session at Vascular Interventional Advances (VIVA) 2021 (5–7 October, Las Vegas, USA).

THIS PIVOTAL TRIAL IS scheduled to enrol at least 100 evaluable patients with acute intermediaterisk pulmonary embolism. This trial is evaluating the efficacy and safety of the Bashir and Bashir S-B endovascular catheters (BECs) in the treatment of acute pulmonary embolism under an investigational device exemption

(IDE) from the US Food and Drug Administration (FDA).

The Bashir endovascular catheter is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. It is also now intended for the controlled and selective infusion of physician-specified fluids,

Bashir endovascular catheter

The intentionto-treat analysis showed an 80% technical success rate in the FemoSeal group, which was higher than the 50% rate achieved in the ProGlide group.” which was higher than the 50% rate achieved in the ProGlide group. The difference in technical success could be explained by the need for additional VCDs and a greater need for manual compression in the ProGlide group, the speaker explained. He elaborated: “In the ProGlide group, when taking

into account the use of a second VCD, the technical success rate was 90%.” Postoperative bed rest and hospital stays were similar in both groups, the presenter communicated.

The rate of minor access-related complications were higher in the ProGlide group, he added, noting finally that the additional cost per patient valued between 23 and 30% in favour of FemoSeal.

Moderator Marianne Brodmann (Medical University of Graz, Graz, Austria) was “really impressed” that Nasr and colleagues had found the device to be more cost-effective, adding a more general comment that it is a “very good idea” to compare two different VCDs for peripheral interventions. In this vein, Brodmann was keen to know if the speaker thought more studies should be conducted and more devices compared in order to end up with one device. “I think we have to talk about other devices,” Nasr replied, noting also that investigators

9

including thrombolytics, into reduction in RV/LV ratio and CT scan at 48 the peripheral vasculature, the absence of device- or hours after enabling the restoration of drug-related adverse events infusion blood flow in patients with are also salutary outcomes. showed venous thrombus.

The expandable infusion that the RV/ The goal of RESCUE basket of the device, with its LV diameter is to achieve an additional pharmacomechanical mode ratio indication for use of these of action, appears to restore decreased devices in the treatment of blood flow promptly. I look by acute pulmonary embolism. forward to the final results This prespecified interim of RESCUE and subsequent analysis was presented by investigations that will Akhilesh Sista, chief of determine the role of this Interventional Radiology, promising novel technology NYU Langone Health, New in the treatment of acute York, USA. The analysis pulmonary embolism.” included 44 males and 18 Brian Firth, chief scientific females with an average age of officer of Thrombolex and principal 58.5 years; 90.3% had high intermediateinvestigator on the Small Business risk pulmonary embolism with both right Innovation Research grant from the ventricular dysfunction and elevated National Heart Lung and Blood Institute biomarkers. Each patient was treated (NHLBI) stated: “The strong support and with 7mg of r-tPA into each pulmonary artery over five hours (a total of 14mg r-tPA in 58 patients with bilateral pulmonary embolism and 7mg in four patients with unilateral pulmonary embolism) at 18 participating centres in the USA. Computed tomography (CT) scan at 48 hours after infusion showed that the right ventricular to left ventricular (RV/ LV) diameter ratio decreased by 32.1% (0.52±0.38: 95% confidence interval [CI] 0.42–0.62, p<0.0001), and the pulmonary clot burden by Refined Modified Miller Index had decreased by 36.3% (8.4±4.3: 95% CI 7.34–9.5, p<0.0001). The successful device placement rate was 100%, there were no device-related complications and the major bleed rate at 72 hours was zero.

“These interim results from the RESCUE trial are very exciting,” said Sista. “The most notable finding is the encouragement that we have received core lab-assessed reduction in pulmonary from the NHLBI as we have conducted thrombus burden at 48 hours, which may this trial, especially in the midst of the translate to better short- and long-term COVID-19 epidemic, has really made outcomes pending further research. The this trial possible.”

32.1%

I look forward to the final results of RESCUE and subsequent investigations that will determine the role of this promising novel technology in the treatment of acute pulmonary embolism.”

must compare devices with magnet compression and low-profile sheaths.

Speaking from the audience, Eric Ducasse (Bordeaux University Hospital, Bordeaux, France) stressed that data

Bahaa Nasr at PVI

concerning other factors—such as the distance between the artery and the skin and previous fibrotic intervention—is required in order to “really compare objectively” the different systems.

Issue 84 | December 2021

Image-guided Surgery Advances 11

Enabling global provision of image-guided procedures “crucial” to improving health equity Janice Newsome (Emory University Hospital, Atlanta, USA), tells Interventional News that she considers herself “a little bit of a global citizen”. “As interventional radiologists, we believe deeply in what we do, every single day—fundamentally, that it improves the health of the patients we treat. And if I believe that, it is only one step further away to see that good healthcare should be available to everyone, everywhere. So, health equity is crucial, both where high-quality healthcare is already being provided, and even more so in places where it is not available, or accessible,” she says.

N

ewsome is also categorical that while she is a strong believer in “interventional radiology”, the desire to take these image-guided procedures to benefit patients in need of them, across the world, means that she is open to looking beyond traditional silos and groups to the broad church of available specialists on the ground. Her sights are set on training really anyone in the healthcare team who can be trained to deliver image-guided procedures, well. “As interventional radiologists, we could never put in all the nephrostomy tubes or all the dialysis catheters that are needed for the population in Tanzania or Rwanda. We really need to be able to partner with the nephrologists seeing these patients; we need to be able to partner with the surgeons that may be already placing subclavian catheters with less-than-optimal outcomes, right? Because again, what we want to do is to advance minimally-invasive procedures. Yes, ideally via interventional radiologists, but really at the end, it is to help with the health of that population and not to really dissect the human body in the way that we have in other parts of the Western world to say that only this specialty can do this here, or only that specialty can do that there. Our goal is to train these skills broadly.

And yes, we prefer that these procedures are done by interventional radiologists, but I find that the best way is to find out who else is on this journey.”

Minimally-invasive procedures for maximum impact

Newsome points to one of the smallest procedures performed by interventional radiologists—percutaneous abscess drainage—as having a colossal impact. “People in every country need to be able to have percutaneous abscess drainage. We can actually get a needle into any cavity, or any place in the body and try to drain infected fluid from that body cavity. That simple procedure has done so much to change outcomes. It should be available to any doctor who can use simple imaging to put a tube in the body to prevent the patient from needing another operation, needing anaesthesia, or long hospital stays, or even potentially, dying.”

Maternal mortality, especially when related to clinically significant postpartum haemorrhage, is another area in which Newsome seeks to move the needle with interventional solutions. “A more advanced procedure that I do think should be available to every woman, everywhere, and will change the percentages of women that die during childbirth, in large part due to bleeding [complications], is embolization. I believe that any doctor, and I hope it is an interventional radiologist, who can safely perform embolization procedures to stop bleeding can help to save a woman’s life during childbirth. I am really passionate about this, because I believe that giving birth should be something that is quite joyous and no one should die while they are trying to bring a life into the world.”

Pain palliation procedures are also singled out as being transformative to populations, be they nerve blocks, or ablation procedures to treat pain. Because pain, in some communities, can change the entire

livelihood of a family.

For instance, in farming communities, farmers with degenerative conditions such as arthritis may not be able to provide for their families due to pain. “Pain has a huge impact on lives. Procedures that can alleviate pain and help with degenerative changes in the body should be provided around the world,” she says.

A local and global need

It is generally accepted that lower- and middle-income countries would be able to improve the health of their populations with the wider deployment of imageguided procedures. Newsome contends: “I would say that the need is great locally. And the need is great globally. Low- and middle-income countries tend to be where we focus on when we talk about global health. I have decided myself to concentrate my efforts in Sub-Saharan Africa and to concentrate that effort into training programmes where sustainability is more important. So medical tourism is not the name of the game and medical missions are not the name of the game. Instead, how we assess what is going on locally in that area and provide the care that that population needs [is the real focus].”

Outreach efforts and training

There have been several organisations over the years that have recognised this deficit of minimallyinvasive procedures in several countries in the world.

“Organisations such as Rad-Aid, Partners Health, Doctors Without Borders, have all done incredible work. I can talk specifically about a programme called Road to IR. This organisation decided to take a different approach to set up curriculum training programmes in partnership with universities to provide in-depth training for interventional radiology. It was birthed in Tanzania, and although this programme began many years ago, three years ago we graduated our first fellowship-trained interventional radiologist from Tanzania who eventually moved back to Rwanda, where he originally came from. We are replicating the same programme Road to IR Rwanda through the generosity of one of our industry partners, and the Memorandum of Understanding signed between Emory University and the Ministry of Health in Rwanda. Our goal there is to continue to provide minimally-invasive procedures through an educational programme knowing very well that you can give a person a fish and they will eat fish on that day, but if you teach a person to fish, they will eat fish every day.”

Elaborating, she adds: “If we are able to get in at the university level and start training interventional radiologists, then we are

going to be able to blanket whole regions and through societies be able to provide examinations to be able to validate this training, so that people can move freely from one country in Africa to the other and still be able to continue their training and then be able to be in practice.”

Newsome acknowledges that the barriers to widespread adoption of image-guided procedures rests in large part on the high cost of disposables, the time of experts and language and translation barriers. Of course, COVID-19 was particularly disruptive for training programmes abroad. Still, she remains upbeat. “Even with that disruption, I will tell you that we have still survived and even thrived during COVID-19. One of the things it taught all of us is really how connected our world is; it also forced us to embrace other technologies in medicine.

Besides the platforms that allow us to speak to each other, procedural telemedicine was birthed during COVID-19. Even in our lab, we were able to broadcast cases initially through what my partners here call ‘ghetto technology’—having one camera look at another camera or my laptop and five iPads in a room, trying to make sure that our learners are still learning, whether these are learners from right here at Emory or learners that are across the pond or ocean. There has also been acceleration in industry development of these technologies. We are going to be way better off in terms of procedural telemedicine or procedural education using these platforms going forward. I am excited about it and there are several of them that are already on the horizons being tested right here,” she says.

Smiling at the margins of progress

What encouraging health equity milestones would bring a smile to Newsome’s face? “I believe that in terms of global health equity, I am going to dance when we are able to have interventional procedure

I am going to dance when maternal mortality is really changed in the USA, considering that I am also right here in Georgia, a state where this is a huge medical issue.” lists deployed in low- and middle-income countries in numbers that are suitable for their populations; I am going to dance when maternal mortality is really changed in the USA, considering that I am also right here in Georgia, a state where this is a huge medical issue. And one single thing that I know from a health equity standpoint that will continue to make me smile is when I see women interventionalists/ women proceduralists taking their rightful role in healthcare. When we are able to break down all those barriers in places in the world where medicine and medical care in the form of minimally-invasive procedures are so male-dominated, I will truly laugh. So, when more women are involved in that space, I believe that we are going to see a lot of change—and I will dance long and hard when those numbers start becoming more equal.”

Janice Newsome

Issue 84 | December 2021

Cryoablation could freeze out lumpectomy in early-stage, low-risk breast tumours

pathologic evaluation after the procedure, since the tumour is not resected.

Compared to heat-based techniques, cryoablation is painless; indeed low temperatures can be analgesic. Further, cryoablation can be performed without sedation safely under limited, simple, local anaesthesia and this is required only for the insertion of the probes.”

Kawamoto and colleagues’ pilot study enrolled eight patients and set out to evaluate the feasibility, safety, and cosmetic outcomes of percutaneous cryoablation of breast intraductal carcinoma lesions, as well as postcryoablation magnetic resonance imaging (MRI) as a follow-up tool for A pilot study, published in the Journal of Cancer Therapy, reveals detection of residual malignancies and that percutaneous cryoablation of early-stage, low-risk breast local recurrences. cancer tumours smaller than 15mm presents a potential substitute A press release states: “The for lumpectomy. independent study conducted at the St Marianna University Breast and Imaging nvestigators, Hinsanoro Kawamoto tumours (<2cm). Available data suggest Center enrolled eight women, 53–72 (Department of Breast Surgery, Breast that elderly women often receive less years of age. Percutaneous ultrasoundand Imaging Center, St Marianna) than the standard care and have worse guided cryoablation of the breast tumour and colleagues report “encouraging short- outcomes because of it, or that was performed using the ProSense to mid-term oncology results with good standard treatments cause more system, under local anaesthesia cosmesis outcomes” for the procedure. complications. without the need for subsequent Cryoablation offers an The pilot study used the ProSense “In my view, the main resection. The procedure lasted alternative cryoablation system (IceCure Medical). advantages of thermal for 40 minutes on average. All approach Setting the scene on the early use ablation areas follows: it is patients received radiation of cryoablation in patients with breast an outpatient procedure; and endocrine therapies. cancer, Jean Palussière (Institut Bergonié, has local efficacy; The patients were Bordeaux, France) tells Interventional results in minimal followed using News: “The main indication of amounts of vacuum-assisted percutaneous thermal ablation for scarring, and has biopsy (VAB), primary cancer in the breast is when a short recovery mammography patients are elderly and surgery is not time with few (MG), MRI, possible either due to comorbidities or complications. and Moiré patients refusing it. Thermal ablation The main Topography may be an alternative to surgery in the disadvantage for cosmetic treatment of primary breast cancer for T1 is related to outcomes.”

I

Cryoablation may offer a surgical alternative for primary T1 tumours (<2cm)

Ablation 13 In September 2021, IceCure announced an Annals of Surgical Oncology publication authored by Richard Fine (West Comprehensive Breast Center, Germantown, USA) and colleagues.

The article reported results previously announced at the American Society of Breast Surgeons Annual Meeting, that at a mean of 34.83 months following treatment with the ProSense system, only 2.06% (four of 194 patients) experienced cancer recurrence.

The ICE3 trial commenced in 2014 and was conducted at 19 US hospitals, including Columbia University Medical Center and Mount Sinai Beth, Israel. The trial enrolled and treated 194 patients (average age of 75) with low-risk, earlystage breast cancer tumours measuring up to 1.5cm.

Fine and colleagues conclude: “Breast cryoablation presents a promising alternative to surgery while offering the benefits of a minimally-invasive procedure with minimal risks.” Fine stated that “the three-year ICE3 trial results highlighting the efficacy and safety of the procedure in this patient group are extremely promising for breast cryoablation. Being able to provide a minimally-invasive option for treating appropriate low-risk patients represents a dramatic improvement in care. The procedure is quick, painless and can be delivered with local anaesthesia in doctors’ offices, with minimal recovery time and excellent cosmetic outcomes.”

The main indication of percutaneous thermal ablation for primary cancer in the breast is when patients are elderly and surgery is not possible either due to comorbidities or patients refusing it.”

Jean Palussière

December 2021 | Issue 84

14 Interventional Oncology

SIO announces ACCLAIM clinical trial with support from industry partners The Society of Interventional Oncology (SIO) has announced the launch of the society’s first clinical trial—ACCLAIM (Ablation with confirmation of colorectal liver metastases), a prospective trial for microwave ablation as a local cure. An SIO press release details that this multimilliondollar trial is funded collectively through grants from Boston Scientific Corporation, NeuWave Medical (part of Ethicon), and Varian, a Siemens Healthineers company.

I

n this prospective, multicentre, international trial SIO proposes to establish microwave ablation 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 SIO believes will drive important changes to future treatment guidelines.

A specialised news source in the vascular arena

The study will incorporate software to assess the ablation zone and margins and determine if achieving complete margins during an ablation equates to procedural success, where the primary outcome is local disease progression at two-years post-ablation.

Constantinos T Sofocleous (Memorial Sloan Kettering Cancer Center, New York, USA) is the principal investigator for the study. “The ACCLAIM trial could impact patient guidelines with regards to the role of ablation as a treatment option for colorectal cancer liver metastases. The study is expected to raise the bar for the standard of care, establishing a reproducible method of achieving Constantinos T Sofocleous tumour ablation with local control,” said Sofocleous. “Clinical research is essential for the continued progress of interventional oncology and SIO will continue to drive such important and focused research efforts.”

According to the press release, despite a favourable safety profile, historically, the inconsistent local tumour progression (LTP) rates after thermal ablation when compared to surgery have limited the widespread adoption of this treatment option in patients with metastatic colorectal cancer to the liver. Suboptimal outcomes and LTP have been attributed to insufficient coverage of the tumour by the ablation zone (tumour and margins). The ACCLAIM study will estimate diseasefree survival of colorectal liver metastases treated with microwave ablation incorporating 3D ablation margin confirmation intraoperatively and through a subsequent

A trusted provider of latest news, review of cutting-edge research, congress coverage and opinion from thought leaders

independent review centralised validation process.

Matthew Callstrom, professor and department chair of radiology at Mayo Clinic (Rochester, USA) is president of the SIO. “It is important to drive what we do as a field forward together, and it takes collaboration and long-term relationships with our industry partners to enable the right studies to be successful,” said Callstrom.

“The ACCLAIM industry partners are raising the bar for research investment by making an important commitment to support societies like SIO. Together, we are advancing our vision to establish interventional oncology as the fourth pillar of cancer therapy.”

Matthew Callstrom Participants of the ACCLAIM trial will be patients with a diagnosis of colorectal cancer liver metastases. Microwave ablation will be performed using a US Food and Drug Administration (FDA)-cleared, commercially available system and using margin confirmation (visualisation) software. The ACCLAIM study is set to launch in 2022 with an expected threeyear enrolment period of 275 participants across sites in the USA and Europe.

The study is expected to raise the bar for the standard of care...”

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Issue 84 | December 2021

Interventional Oncology 15

Remote controlled percutaneous interventional oncology procedure with ACE Xtend revealed XACT Robotics has announced what it claims is the world’s first remote controlled robotic instrument insertion and non-linear steering during a percutaneous interventional oncology procedure with ACE Xtend. ACE Xtend is the remote-control feature of the XACT ACE robotic system, which the company has billed as the world’s first comprehensive robotic system that integrates imageguided planning and real-time monitoring with precise robotic insertion and non-linear steering to deliver various instruments to a desired target in the body. This procedure was successfully completed by the interventional radiology team at Sarasota Interventional Radiology in Sarasota, USA. “WE ARE VERY EXCITED ABOUT the addition of remote capabilities with ACE Xtend, that can improve workflows, allow us to perform more procedures, and better support our patients and staff,” said Gerald Grubbs (owner of Sarasota Interventional Radiology). “The ability for our interventional radiology team to perform procedures without having to enter the procedure room also increases overall safety by reducing the risk of exposure to radiation and other harmful pathogens.”

In percutaneous procedures for diagnosing and treating certain cancers and other diseases, accuracy in reaching

targets of interest within the body is extremely important. In many cases, movement caused by the patient or within the body can change the location of the target of interest during the procedure.

With percutaneous procedures that are carried out and completed manually, it is often necessary to repeat a procedure if an instrument does not reach its target successfully, increasing risk for both patients and healthcare providers. XACT Robotics’ technology helps improve accuracy and consistency so any user can reach targets that are small or in hard-to-reach areas, typically on the first insertion, potentially leading to better

patient outcomes.

Press material from the company notes that the XACT ACE robotic system’s unique features were proven in over 200 clinical and preclinical cases to improve tip-to-target accuracy, efficiency, and consistency in interventional percutaneous procedures.

The system has received US Food and Drug Administration (FDA) clearance for use during CT-guided percutaneous procedures, as well as the CE mark, and commenced commercialisation in October 2020.

In 2019, the company announced that its robotic system was cleared to market in the USA for use during computed tomography (CT) guided percutaneous interventional procedures.

At the time, Nahum S Goldberg, head of Interventional Oncology Unit and director of the Applied Radiology Research Lab, Hadassah Hebrew University Medical Center, Jerusalem, Israel and principal investigator in a multisite study using the system said: “The XACT robotic system provides a unique platform to the interventional radiology community which can help

ACE Xtend is the remote-control feature of the XACT ACE robotic system

improve the delivery and quality of care for the patients we serve.

“Based on our experience with this unique robotic technology, we can reach very small targets with unprecedented accuracy. Furthermore, this system holds much promise for enabling more efficient use of time and hospital resources.”

We are very excited about the addition of remote capabilities with ACE Xtend, that can improve workflows, allow us to perform more procedures, and better support our patients and staff.”

December 2021 | Issue 84

16 Interventional Oncology

MIO-Live and worldwide opportunities in interventional oncology Roberto Iezzi Comment & Analysis As new technologies open the door for more personalised treatments in interventional oncology, Roberto Iezzi considers the evolving delivery of care for cancer patients. Touching on a theme of interdisciplinary and inter-societal learning, Iezzi sets the scene for the forthcoming Mediterranean Interventional Oncology Symposium (MIO-Live, 24–25 January 2022, Rome, Italy and virtual), which will bring together experts and organisations from east and west to share research and experience in new approaches.

T

he era of personalised medicine presents a great challenge and opportunity for diagnostic and interventional oncology. The need for minimally-invasive cancer treatments is growing to address the continuous rise of cancer in an ageing, global population.

As technical capabilities have improved, new procedures have been developed focusing on innovation and clinical evidence, and minimally invasive interventions have become generally preferred over more invasive alternatives. Furthermore, the findings and developments of biomedical research have provided growing insight into the molecular machinery of cancer, identifying oncological control mechanisms for potential therapeutic purposes.

Role of locoregional therapies

Locoregional therapies will play a crucial role in the treatment of patients with cancers, particularly due to the increasing complexity of the medical world in future years, which includes older patients with comorbidities requiring individualised

therapies, growing health-economic and structural pressure, increased requirements for “patient comfort” with an emphasis on short inpatient stay or outpatient therapy concepts, more drugs, the emergent role of immuno-oncology, new applications for artificial intelligence (AI) producing new evidence and crossconnections, and the emergent role of cyber technologies.

According to many current recommendations in various national and international cancer treatment guidelines, the mindset of therapeutical concepts has reoriented towards personalised therapy approaches. In this clinical scenario, it is mandatory to be part of a multidisciplinary tumour board, working with a multimodal approach, thinking about interdisciplinarity as the best achievement to obtain. We need to delete any boundaries between the various specialties, requiring cross-over knowledge about disease, treatment concepts, side-effects, concomitant therapies, and locoregional treatments.

However, treatment selection also needs to be personalised based upon local availability, skills and experience

so that we can have few striking differences when comparing worldwide interventional oncology guidelines or indications. In detail, it is well known that eastern and western management of cancer patients differs on many points, reflecting different cancer and patient features as well as different diagnostic and therapeutic approaches. These are mainly down to country-specific issues.

However, guidelines are supposed to suggest rather than impose on the clinical management of patients, and their application in real life has been debated.

Guidelines should not be intended to replace doctors’ personal experience but

Guidelines should not be intended to replace doctors’ personal experience but could provide physicians with the most up-to-date options for their patients, directing them toward the most suitable option for each specific individual, based on the level of evidence and strength of recommendation.” could provide physicians with the most up-to-date options for their patients, directing them toward the most suitable option for each specific individual, based on the level of evidence and strength of recommendation.

Such differences would stir the debate among international interventional oncology experts, resulting in intersocietal exchange to define the best

Checkpoint blockade plus cryoablation stimulates immune remodelling in advanced kidney cancer

The University of Texas MD Anderson Cancer Center’s (Houston, USA) November research highlights provide a glimpse into current advances evaluating immunotherapy plus cryoablation to treat metastatic kidney cancer.

CRYOABLATION IN combination with immune checkpoint inhibitors stimulated anti-tumour immune responses in preclinical studies. To examine whether this combination is safe and feasible for patients, Matthew Campbell and Padmanee Sharma led

a pilot clinical study in patients with metastatic renal cell carcinoma, including 18 with clear cell and 11 with non-clear cell histology. Patients received the anti-CTLA-4 therapy tremelimumab with or without cryoablation. Immunemediated toxicities of grade 3 or greater

protocols for managing oncological patients. Nevertheless, more active communication and interaction between societies could also enhance the quality of delivered care in specific countries.

MIO-Live: Joining east and west

Based on this background, the next edition of MIO-Live will be a practical, interactive meeting based on live cases spaced out with short presentations and lectures, where professionals from various countries of the world will be able to share opinions, experiences, research projects and the valued knowledge of several international experts. Dedicated sessions focused on discussion of cases with different eastern and western perspectives will have a role in increasing the reach of the guidelines, fostering worldwide collaborative projects aimed at filling gaps in knowledge with balanced, evidencebased approaches.

The next edition of MIO-Live will be endorsed by multidisciplinary societies, such as the Mediterranean Association for the Study of Liver (MASL) and Mediterranean Task Force for Cancer Control (MTCC), established in 2004 as a non-profit, non-governmental organisation open to representatives of the Mediterranean bordering countries as well as other countries. It will also have the backing of worldwide Interventional Radiology Societies, such as Cardiovascular and Interventional Radiological Society of Europe (CIRSE), Society of Interventional Oncology (SIO), Korean Society of Interventional Radiology (KSIR) and Korean Society of Image-Guided Tumor Ablation (KSITA). These joint sessions will give us the opportunity to highlight the recent developments in the management of cancers and to compare the differences in clinical practice between eastern and western countries, with a final critical analysis of the different conceptual approaches underpinning the treatment of cancer patients.

Roberto Iezzi is head of the Interventional Radiology Unit at Policlinico A Gemelli, Rome, Italy. He is one of the course directors of MIO-Live (www.miolive.eu).

were observed in 55.2% of patients, in keeping with previous studies of immune checkpoint blockade in renal cell carcinoma.

Although clinical responses were limited, immune analyses of pre- and post-treatment samples revealed that cryoablation increased immune cell infiltration and the presence of tertiary lymphoid structures in clear cell renal cell carcinoma.

The findings suggest this combination is feasible and can stimulate favourable changes in the immune microenvironment in certain patients with metastatic kidney cancer. The study was published in Nature Communications.

December 2021 | Issue 84

18 Interview

PROFILE

Laura Crocetti

“I think the future success of ablation was truly unforeseeable, in 1986, when Tito Livraghi published his first paper about ethanol injection in a liver tumour. If we accurately match the energy source, the route of energy delivery and imaging with the specifics of the lesion, we can treat lesions in almost every organ and anatomical space. Sometimes, it is necessary to enter the operating room together with the surgeon in order to get the best treatment results for the patient, but this should be seen as another opportunity— not an event to escape from,” says Laura Crocetti, associate professor of Radiology, Division of Interventional Radiology, Nuovo Santa Chiara University Hospital, Pisa, Italy. An internationally recognised ablation expert, she is also deputy chairperson of the European Conference on Interventional Oncology (ECIO) for 2022 and 2023.

When I was in medical school, I was attracted by minimally-invasive treatments that enabled the possibility of curing patients with minimal damage and discomfort. The other passion I had was for technology and the latest developments on the horizon. So, when I heard of interventional radiology, I immediately realised that represented my future.

Who are your mentors?

I did my medical degree at the University of Pisa and at that time, Carlo Bartolozzi and Riccardo Lencioni, internationally recognised liver experts, were at the helm. I then did my PhD and became assistant professor at the same university under their mentorship. I was lucky indeed! Even as I put in years of hard work, I absorbed and learned so much. I am really grateful to them, especially for, their rigour and severity. Subsequently, I found mentors in the scientific community: each congress and meeting brought opportunities for me to widen my knowledge, bring home new ideas, and begin new ways of practising interventional radiology.

Could you share a positive and negative experience you have had as a woman in the interventional field?

I will start with a negative experience: I am a smallframed woman (my son says I am “short”) typically dressed in a non-slim-fit green working uniform and perhaps looking a few years younger than her age.

Unfortunately, that is not what most patients expect when told they are scheduled to meet “professor” Crocetti, a “well-known” expert in the field of ablation who will perform the procedure. Still, an empathetic bond is almost always immediately formed, and they feel reassured and protected “in my hands”. Patients often witness their appreciation with very kind messages and emails afterwards.

The first surprise is unfortunately also sometimes observed in older, male leaders and colleagues who do not know you. Interestingly, you can seem transparent or invisible to their eyes. The important thing is that in the long term, I have always been able to convince my colleagues about my professional capacity and am very proud of this.

The positive experience as a woman physician often comes from everyday interactions with my female colleagues: the positive and supportive feeling is immediate and the desire to cooperate and work together very strong. As female physicians, we are thorough, efficient and well organised, and our results are usually very good!

What are the most important cancer imaging techniques that you see on the horizon?

I am extremely optimistic about the future of magnetic resonance (MR) and would like to emphasise its as-yet insufficiently explored aspects. Function, metabolism and vascularisation can all be investigated with this technique. The vast amount of information that magnetic fields can provide is almost infinite. I am fortunate to have a very interesting opportunity to cooperate with the 7T consortium in Pisa (IMAGO 7) and the team really conveys that we are only at the beginning with MR. The application of MR in cancer imaging, for example before and after chemoradiotherapy or interventional radiology procedures, will remain a hot topic in the future.

Where do you see the greatest potential for ablative therapy?

I think the future success of ablation was truly unforeseeable, in 1986, when Tito Livraghi published his first paper about ethanol injection in a liver tumour.

The potential of ablative treatments stem from their ductility combined with efficacy. If we accurately match the energy source, the route of energy delivery and imaging with the specifics of the lesion (its size and location, roughly speaking), we can treat lesions in every organ and anatomical space. Sometimes, it is necessary to enter the operating room together with the surgeon in order to get the best treatment results for the patient, but this should be seen as another opportunity— not an event to escape from.

A personalised approach for patient care includes not only choosing an interventional treatment and selecting the correct timing for it, but also picking from all the different energy sources and imaging approaches available to optimise treatment success.”

Do you see different niches for radiofrequency, microwave and cryoablation?

Each ablative modality has its specificity. Generally speaking, at the moment my workhorse for the liver is microwave ablation, but for kidney, soft tissue and prostate, I prefer cryoablation. I can see a future of selected microwave devices in thyroid and lung as well,

Andy Watt/NB Illustration

What attracted you to a career in interventional radiology?

but at the moment I still prefer radiofrequency here.

A personalised approach for patient care includes not only choosing an interventional treatment and selecting the correct timing for it, but also picking from all the different energy sources and imaging approaches available to optimise treatment success.

What evidence would you like to see generated in your field of special interest– liver ablation?

Liver ablation is an area where we actually have quite a lot of evidence, especially when compared with other organs. Its efficacy and cost-effectiveness, for example, has been well established in hepatocellular carcinoma (HCC) and it is recognised in the major guidelines.

I am very much looking forward to the results of the COLLISION trial, the noninferiority randomised study comparing ablation and resection in ablatable and resectable colorectal liver metastases of less than 3cm.

Issue 84 | December 2021

Interview 19

In the near future, I think we should produce evidence about the role of combination therapies including ablation and immunotherapy.

You have declared the International Accreditation System for Interventional Oncology Services (IASIOS) accreditation to be an important milestone for your hospital. Why?

IASIOS accreditation is a way of demonstrating first to us and then to the global community that the interventional oncology service we provide is of high quality and meets rigorous international standards.

It helps to improve the whole process of patient care and treatment, and is specifically designed for medical facilities offering interventional oncology. Accreditation already exists for other specialties or services, and it is extremely important to have it already up and running for interventional oncology.

As deputy chairperson for ECIO 2022 (24–27 April, Vienna, Austria), what would you like the programme to reflect?

ECIO is by definition a multidisciplinary meeting and the programme will reflect this special attitude of the congress. All topics will be addressed from multiple points of view and there will also be lots opportunities to speak about ongoing research and new technologies.

It is really a privilege for me to work with Philippe Pereira, the chairperson of ECIO 2022, to prepare the programme (www.ecio.org).

Could you describe a memorable case that has stayed with you?

It is the first liver radiofrequency ablation I performed many years ago, for sure. My heart was beating very fast…but everything went smoothly. I also recall all the difficult cases, those in which I had complications; I remember them all very well. Many of my patients have, fortunately, been able to live with a very long disease history and two of them, in particular, have become family friends. It has been very difficult to say to them that there was nothing further I could offer them and their families from an interventional treatment perspective.

What are your interests outside of medicine?

I love the sea, and particularly enjoy fishing and have a licence for a boat. My other passion is music and I am a conservatory graduate in piano. Hiking with my husband, Francesco, and son, Aurelio, is a family activity we enjoy together.

Present

Associate professor of Radiology, Division of Interventional Radiology, Nuovo Santa Chiara University Hospital, Pisa, Italy

Medical education

1998: Medical degree, cum laude, Medical School of the University of Pisa Residency in Radiology and Interventional Radiology, University of Pisa

2007: PhD European Board in Interventional Radiology (EBIR)

Society positions

2022–23: Deputy chairperson of the ECIO Chairperson of the Standard of Practice Committee of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2011: Fellow of CIRSE 2018–2021: Member of the Oncology Alliance Subcommittee of CIRSE 2016–2019: Member of the Scientific Programme Committee,

CIRSE congress 2018–present: Member of the International Accreditation System for Interventional Oncology Services (IASIOS) Committee Scientific advisor for the Italian College of Interventional Radiology (ICIR) 2021 annual meeting 2017–present: Section editor for for nonvascular interventional radiology, CardioVascular and Interventional Radiology 2012–20 Associate editor for interventional radiology, Radiology

December 2021 | Issue 84

20 Interventional Advances

Cooled radiofrequency ablation relieves pain after knee replacement

A minimally invasive ablation procedure offers long-term relief for patients who experience chronic and debilitating pain after knee replacement surgery, according to a study being presented at the annual meeting of the Radiological Society of North America (RSNA; 28 November– 2 December, Chicago, USA).

ARTHRITIC KNEE PAIN IS A MAJOR CAUSE of disability around the world. More than 14 million Americans suffer from knee arthritis. Many go on to have a severe form of the disease, creating intense pain and lack of mobility.

A growing number of these patients are opting for total knee arthroplasty, or replacement, in the hopes of regaining mobility and having a better quality of life. Unfortunately, 15–30% of people who get a knee replacement continue to experience pain and stiffness in the knee. They can go through surgery again, but there is no guarantee that the pain will not return.

“A lot of patients do not achieve any resolution of pain,” said study lead author Felix Gonzalez, (Division of Musculoskeletal Imaging of the Department of Radiology and Imaging Sciences at Emory University School of Medicine, Atlanta, USA). “It is a big problem, and up to now, there were not any other options.”

A procedure called cooled radiofrequency ablation

(C-RFA) offers hope for these patients, an RSNA press release states. The procedure involves insertion of an introducer needle around the knee under local anaesthesia targeting specific nerve locations. A probe is then guided through the introducers. The tip of the probe ablates the deep sensory nerves around the knee.

Water circulating through the system allows for a greater dissipation of heat from the tip of the probe.

“With a larger propagating heat wave, you can account for the differences in nerve anatomy from patient to patient because of a larger treatment zone,” Gonzalez said. “Treating a larger zone increases the effectiveness of the procedure.”

In previous studies, Gonzalez and colleagues showed that C-RFA provides lasting pain relief for people with knee, shoulder and hip arthritis. The new study focused on 21 patients who were experiencing persistent chronic pain after total knee replacement, without underlying hardware complications. The patients had all failed conservative care. They filled out clinically validated questionnaires to assess pain severity, stiffness, functional activities of daily living and use of pain medication before and after the procedure. Follow-up

The procedure involves insertion of an introducer needle around the knee targeting specific nerve locations.

IVUS linked with improved health outcomes in large-scale analysis of lower extremity peripheral vascular interventions Philips announced the results of a new large-scale real-world analysis of Centers for Medicare & Medicaid Services (CMS) data on the health outcomes of peripheral vascular interventions guided by intravascular ultrasound (IVUS).

THE STUDY WAS CONDUCTED independently by the Smith Center for Outcomes Research at Beth Israel Deaconess Medical Center (Boston, USA), with the results presented at Transcatheter Cardiovascular Therapeutics (TCT) 2021 (4–6 November, Orlando, USA and virtual)

by Eric A Secemsky, director of Vascular Intervention and interventional cardiologist at Beth Israel Deaconess Medical Center and assistant professor of Medicine at Harvard Medical School in Boston, USA. The study was supported by Philips.

The new study results now show that the outcome observations from these prior studies apply directly to a broader patient population and across vascular beds, demonstrating strong support for the use of IVUS during peripheral interventions,

according to a press release.

“The results of this large-scale study demonstrate favourable long-term outcomes in peripheral vascular interventions when IVUS is used,” said Secemsky. “This analysis, combined with the recent appropriate use consensus on IVUS that was presented at Vascular Interventional Advances (VIVA; 5–7 October, Las Vegas,

outcome scores were collected up to one year after the C-RFA procedure.

Questionnaire results showed that the patients experienced, on average, a statistically significant improvement in quality of life. Both pain and stiffness scores improved dramatically. No major complications were encountered, and no patients required repeat treatment, surgical revision or other intervention.

“This procedure can have a huge impact on patients who have gone through major surgery and are still suffering pain that is very debilitating,” Gonzalez said.

The procedure’s long-term relief gives it a major advantage over cortisone injections, which offer on average only about three months of pain relief in the treatment of knee arthritis.

This procedure can have a huge impact on patients who have gone through major surgery and are still suffering pain that is very debilitating.”

“It is very encouraging that up to a year out these patients have such significant pain relief and a better quality of life,” Gonzalez said. “The hope is that in that period of time, the patient can become more mobile and increase their activity. Even if pain comes back, we predict that it will not come back with the same intensity as before.”

Since it is minimally invasive, the procedure can easily be repeated, according to Gonzalez. It can also reduce or eliminate the use of opioid pain relievers, which carry significant risks associated with dependency. “We hope that this procedure will become a standard of treatment for pain in this setting,” he concluded.

USA), highlights a clear opportunity to improve health outcomes for millions of patients by broader and more routine implementation of the technology in clinical practice. This is a moment for us to further our efforts in saving lives and saving limbs.”

Peripheral arterial disease: A 32% reduction in major adverse limb events, including amputations, during lower extremity arterial interventions

The study looked at Medicare beneficiaries aged 65 years or older who underwent lower extremity arterial interventions between 1 January 2016 and 31 December 2019. Among 697,794 interventions, the investigators found a 32% reduction in major adverse limb events, such as amputations, over a median 425 days of follow-up.

These findings were consistent across disease states, including chronic limbthreatening ischaemia (CLTI) and nonCLTI, as well as arterial segments such as iliac, femoropopliteal and tibial.

Chronic venous disease: A 31% reduction in repeat intervention, hospitalisation or death during iliofemoral venous stenting

Separately, the investigators examined Medicare beneficiary data for patients treated between 1 January 2017 and 31 December 2019 in multiple clinical settings, including hospital in-patient settings, hospital outpatient centres and private office-based clinics, involving 20,984 individual patients. Of these, 72% underwent stenting guided by IVUS. When IVUS was used, there was a 31% reduction in the composite outcome of repeat intervention, hospitalisation or death. In addition, IVUS use reduced the risk of stent thrombosis, embolization and stenosis.

First global consensus on appropriate use of IVUS in peripheral interventions

In October 2021, a team of clinical experts led by Secemsky established the first-ever global, cross-specialty expert consensus for the appropriate use of IVUS in peripheral vascular disease interventions. “Today, healthcare providers’ use of IVUS in peripheral vascular disease interventions is not standardised and is therefore inconsistent. The new appropriate use expert consensus may help establish global standards of care to adopt into guidelines and improve quality of care in peripheral vascular disease,” a press release states.

Issue 84 | December 2021

Renal Interventions 21

VASCULAR ACCESS

Five-year Ellipsys data bolsters benefits of percutaneous fistula creation The Ellipsys vascular access system (Avenu Medical/Medtronic) can be used to easily and safely create durable percutaneous arteriovenous fistulas (pAVFs) for haemodialysis—with new, long-term data suggesting it offers an “excellent alternative” to AVF creation via surgical procedures in end-stage renal disease (ESRD) patients. That is according to Jeffrey Hull, an interventional radiologist and director of the Richmond Vascular Institute in Richmond, USA, who presented five-year results from the Ellipsys US pivotal trial at this year’s American Society of Nephrology (ASN) Kidney Week (2–7 November 2021, virtual).

A

nd, speaking to Interventional News regarding (102/107 patients) and a clinical success rate of 95% the role endovascular AVFs now play within (98/103 patients), with an average procedure time access creation strategies, Hull stated: “Once of 24 minutes also being observed. He added that you get past the wrist issue, I would say it could the target vein was the cephalic vein in the majority be percutaneous fistula first. If you are a candidate of cases (74%), followed by the basilic (24%) and for a fistula, but not a great wrist fistula candidate, brachial (2%) veins. Discussing maturation procedures then maybe the first possible fistula that should used in the trial, Hull noted that percutaneous be considered for you is a percutaneous transluminal angioplasty (PTA) proximal to fistula—and I think the data are the fistula was used in 72% of cases, promising enough to support this.” while branch (35%) and deep Hull began his ASN Kidney (32%) embolization, cubital While the US pivotal trial Week presentation by briefly vein ligation (31%) and recorded that 2.66 additional demonstrating the procedure transposition (26%) were procedures per patient per through which a proximal also deployed. year were required (which is radial artery fistula is created a figure comparable to those using the Ellipsys system— Results associated with surgically noting the application of Hull then noted that, at onecreated fistulas at one year) pressure and heat to “weld” year follow-up, fistula-related the target vein and proximal events including thrombosis, radial artery together. This stenosis, cannulation-related differs from more traditional, injuries or difficulties, and steal surgical procedures in which syndrome, generally looked suturing is used to create the “very similar” to those seen in anastomosis between these surgically created fistulas— YEARS YEARS vessels, he added. Hull also something that he stated was noted that balloon dilatation “a little disappointing” at that is commonly used to relieve stage. He did add, however, spasm in the anastomosis that the Ellipsys US pivotal shortly after the procedure. trial met its primary efficacy endpoint, as 86% (92/107) of Study details fistulas were mature at He went on to provide 90 days, and met the audience with its primary safety during years two per patient an overview of the endpoint, due to through five, a per year—ranging Ellipsys US pivotal there being no “drastic reduction” in from 0.18 to 0.57 trial, a prospective, serious, deviceadditional procedures —was observed. multicentre, related adverse single-arm study events. intended to Discussing the evaluate the safety crux of his ASN and effectiveness of Kidney Week AVF creation using the presentation, Ellipsys device. It involved Hull reported a total of 107 patients treated across five outpatient, that a total of 85 patients were eligible office-based labs, he reported, adding that—aside from for further follow-up at one year and the the fact 76 (71%) of these patients were male—the trial’s investigators continued to follow baseline characteristics of these patients were “typical up these patients out to five years. of those seen in dialysis patient populations”, with Regarding the first of several long-term a mean age of 56.6 years and an obesity prevalence endpoints—fistula use, assessed by of 50%. two-needle cannulation—Hull told Moving on to discuss one-year data from this the audience that 92% (83/90) of trial, Hull reported a technical success rate of 95% these fistulas were used in patients

2.66

2

0.18

5

0.57

requiring dialysis, describing this as “an excellent outcome” that compares favourably to the 63% rate of two-needle cannulation observed in US patients with surgically created fistulas. He further noted that fistula non-use was low, with 11 of the 24 patients whose percutaneous fistula was unused ultimately not requiring haemodialysis.

Outlining access complications through five years, Hull said 27 patients experienced complications including fistula dysfunction (21.2%), cannulation injury (12.9%), thrombosis (5.9%) and arm swelling (4.7%)—with these being typical of those seen in dialysis patient populations. A total of 91 additional procedures were performed to rectify these issues, he stated, with the most commonly observed types being balloon dilatation (n=71) and thrombectomy (n=12), followed by stent grafting (n=6) and surgical repair (n=4).

Hull also noted, regarding additional procedures per patient per year in the US pivotal trial, that this figure (2.66) was similar to those associated with surgically created fistulas at one year, but that in years two through five a “drastic reduction” in additional procedures per patient per year—ranging from 0.18 to 0.57—was observed. “We attribute that to the lowto-moderate flow in these [percutaneously created] fistulas, averaging 1,000ml per minute, and also the multi-outflow feature of these fistulas whereby, if an injury occurs, the blood will flow around it and keep the fistula operational until it can be repaired,” he reported.

Summary

Touching on the final long-term endpoint from the trial, Hull relayed “excellent” primary assisted and secondary patency rates of 74% and 82%, respectively, at five years as per Kaplan Meier estimates, while the functional patency rate was found to be 91.8% through the follow-up period as well. Hull explained that, moving forward, the goal is to reduce the time to two-needle cannulation for the Ellipsys system, with cannulation- and cost-related issues also continuing to be evaluated further.

“In summary, this follow-up study has shown us several important things—the first being that highquality fistulas can be performed by interventional nephrologists,” he concluded. “Secondly, we have expanded the places in which these fistulas can be created, not just in the hospital but now in office-based labs and ambulatory surgery centres too,” he said.

Jeffrey Hull

December 2021 | Issue 84

22 Aortic Interventions

CX AORTIC VIENNA

Physicians and industry alike urged to tackle multifactorial stroke risk following thoracic endovascular procedures As evidence builds on the importance of reducing the risk of stroke by removing residual air prior to thoracic endovascular aortic repair (TEVAR) procedures, the onus will be on surgeons and device manufacturers to minimise this risk—as per a discussion at CX Aortic Vienna 2021 (5–7 October, broadcast). This session also focused on findings from the Stroke from thoracic endovascular procedures (STEP) study, and featured a first-to-podium presentation highlighting the benefits of carbon dioxide compared to standard saline flushing after TEVAR. TILO KÖLBEL (GERMAN AORTIC CENTRE Hamburg, Hamburg, Germany) began this session by introducing the problem of cerebral damage following both TEVAR and transcatheter aortic valve implantation (TAVI) procedures—noting that

the relatively low rate of postoperative stroke “does not tell the whole story”, as silent brain infarctions (SBIs) are far more prevalent and can lead to a range of neurological disorders later in life. He went on to detail that, while the source of stroke and SBIs is multifactorial, air embolisation caused by devices used in TEVAR and TAVI is one of the key contributors.

Following this, Fiona Rohlffs (German Aortic Centre Hamburg, Hamburg, Germany) outlined the increased removal of residual air that can be achieved by introducing carbon dioxide to the standard, saline-based flushing technique often used in TEVAR, as well as the additional benefit of adding an extra flush port to the stent graft delivery system.

She went on to report preliminary results from the STEP study, which included the first cohort in which carbon dioxide-flushed devices had been deployed in endovascular aortic arch repairs, noting an SBI incidence of about 50%—which compares favourably to the 80% rate reported in standard flushing without carbon dioxide.

Session moderator Markus Steinbauer (Barmherzige Brüder Hospital, Regensburg, Germany) stated that the industry is now taking notice of this research into the importance of removing residual air prior to these procedures, with many companies that manufacture TEVAR devices currently attempting to introduce features like additional flush ports. This prompted Roger Greenhalgh (Imperial College London, London, UK), the session’s anchor, to claim that research from the STEP registry is paving the way for surgeons themselves to systematically consider how they can minimise stroke risks following thoracic endovascular procedures, before agreeing with Rohlffs that this is a

multifactorial problem, and efforts to reduce liquid and solid embolization are also key.

Evidence on the potential benefit of introducing carbon dioxide into this complex picture was then built upon by Richard Gibbs (Imperial College Healthcare NHS Trust, London, UK), who presented the results of a non-randomised, prospective study comparing carbon dioxide and standard saline flushing in 187 patients.

Gibbs reported no difference in clinical stroke outcomes, but did highlight a significant reduction in the total number and surface area of new diffusionweighted magnetic resonance imaging (DW-MRI) infarcts after carbon dioxide flushing. He concluded that patients are now being randomised across the UK, USA and New Zealand in a larger study designed to further examine this phenomenon.

More insight came from Wolf Eilenberg (German Aortic Centre Hamburg, Hamburg, Germany and Medical University Vienna, Vienna, Austria), who discussed the largest cohort study investigating cerebral microbleeds (CMBs) after TEVAR to date, in which 50% of patients presented with SBIs and 60% had CMBs—warranting further research, not only on the risk factors associated with CMBs, but also their long-term clinical impact. Greenhalgh echoed this view, describing these microbleeds as a “moving target” of which a greater understanding is needed. Referring more broadly to the growing body of evidence on postTEVAR stroke, Greenhalgh concluded: “Those who are working on this subject are influencing the industry. And, the industry will do all it can, but surgeons will also have to do everything they can— it is a combined effort and, together, we are making progress.”

Patients should get a choice between open and endovascular surgery for aortic conditions, CX audience agrees

A decisive vote at CX Aortic Vienna 2021 (5–7 October, broadcast) revealed that 90% of the audience was in favour of offering patients a choice between open and endovascular surgery for aortic arch procedures. Edited cases from Thomas Gandet (Arnaud de Villeneuve Hospital, Montpellier, France) and Tilo Kölbel (German Aortic Centre Hamburg, Hamburg, Germany) were among presentations that helped to inform this audience poll. The importance of providing both open and endovascular approaches was also raised in a discussion on aortic coarctation and in a session on dissection.

GANDET’S PRESENTATION outlined the Endo-Bentall procedure—a new endovascular treatment used in ascending aortic pathologies that was later described by moderator Afshin Assadian (Hospital Ottakring, Vienna, Austria) as the “final frontier” in this space. Gandet, a cardiac surgeon, was keen to stress the importance of collaboration between cardiac and vascular surgeons in optimising this complex procedure.

Following this, Kölbel described an aortic arch repair with a threebranched stent graft, concluding that the procedure is feasible and that the use of a steerable sheath reduces cervical

access trauma. He noted that, while there is not much published on the topic, short- and midterm outcomes from his own group, and those from Stéphan Haulon (Aortic Centre Marie Lannelongue, Groupe Hospitalier Paris Saint Joseph, Paris, France) and colleagues, have been “very positive” to date.

In addition to an earlier session debating the role the open elephant trunk technique can play in aortic arch challenges, which saw 100% of CX Aortic Vienna attendees vote in favour of this approach continuing to be taught, these edited cases formed the basis on which the audience decided

Clockwise from top left: Roger Greenhalgh (London, UK); Roberto Chiesa (Milan, Italy); Afshin Assadian (Vienna, Austria); Tilo Kölbel (Hamburg, Germany); and Thomas Gandet (Montpellier, France).

that patients should be offered a choice between open and endovascular options. Further insight on this topic later came from W Anthony Lee (Florida Atlantic University, Boca Raton, USA), who presented an edited case detailing total endovascular repair of the aortic arch using the Relay triplebranch device (Terumo Aortic), and Kazuo Shimamura (Osaka University Graduate School of Medicine, Osaka, Japan), who discussed the possibility of reducing the risks of stroke and type 1 endoleak via the endovascular ‘chimney technique’ (Gore).

Discussion also turned to the importance of offering both open and endovascular solutions in a session on aortic dissection. Chair Roger

Greenhalgh (Imperial College London, London, UK) asked moderator Martin Grabenwöger (Clinic Floridsdorf, Vienna, Austria), a cardiac surgeon, his opinion on whether offering every patient the opportunity of both treatment options should become the norm in the future. “Yes,” he replied, detailing that, in his practice, Grabenwöger takes into account various factors when assessing a patient, including age. While he will choose open surgery for certain patients, he noted that for patients with a lot of comorbidities, he opts for partnering with his endovascular colleagues in the hybrid room.

A decisive vote revealed that 90% of the audience was in favour of offering patients a choice between open and endovascular surgery for aortic arch procedures.”

Issue 84 | December 2021

Venous Highlights 25

Three-year venous stent data keep patency ambitions, low reintervention rates and clinical improvement open over time Three-year results of the VIVO clinical study support the continued safety and effectiveness of the Zilver Vena venous stent (Cook Medical) in the treatment of symptomatic iliofemoral venous outflow obstruction, a VIVA Foundation release summarises. Paul Gagne (The Vascular Experts, Darien, USA) presented the new data at Vascular Interventional Advances (VIVA) 2021 (5–7 October, Las Vegas, USA).

P

atients with symptomatic obstruction of one iliofemoral venous segment were enrolled (i.e. Clinical, aetiology, anatomy, pathophysiology [CEAP] clinical classification ≥3 or Venous Clinical Severity Score [VCSS] pain score ≥2). Follow-up through three years included measures of patency, reintervention, clinical outcomes (measured by VCSS, vascular duplex scan [VDS], CEAP “C”, and Chronic Venous Insufficiency Questionnaire [CIVIQ]), and device integrity measures of fracture and migration.

The VIVO study enrolled 243 patients (70% female; mean age, 53±15 years; 67.5% with current or past deep vein thrombosis). The 30-day primary safety endpoint and one-year primary effectiveness endpoint were met, exceeding the corresponding performance goals (p<0.0001), and improvement in clinical outcome measures was demonstrated at one-year (p<0.0001).

Follow-up through three years is complete, Gagne told VIVA attendees, reporting that results observed at one-year were maintained. Specifically, threeyear outcomes include high rates of patency by ultrasound (90.3±2.2%), freedom from clinicallydriven reinterventions (92.6± 2%), and freedom from reinterventions (82.9±2.6%). Clinical improvement, as measured by VCSS, VDS, CEAP “C”, and CIVIQ, was sustained through three years (p<0.0001).

There were no core lab-reported stent fractures, and only one core lab-reported migration (adjudicated as technique-related due to device undersizing) through three years.

Three-year data for Venovo show 84% primary patency and low reintervention rates

In September 2021, Michael Dake (University of Arizona Health Sciences, Tucson, USA) and VERNACULAR investigators reported three-year outcomes for the Venovo venous stent (BD) in the journal CardioVascular and Interventional Radiology (CVIR).

They write that the Venovo venous stent was successfully deployed in obstructive iliofemoral vein lesions and met the prespecified primary outcome measures through one year. At three years, primary patency was 84%, reintervention rates were low, standardised quality-of-life and pain measures improved from Michael Dake baseline, and there was no stent

Early thrombosis after Iliac stenting for venous outflow occlusion is related to disease severity and anticoagulation type Fewer than 10 days of low-molecular-weight heparin (LMWH) after stenting for extensive iliofemoral venous occlusion prior to transition to oral anticoagulation reduces early thrombosis, according to a multicentre study.

THROMBOSIS FOLLOWING iliofemoral venous stenting is frustrating to both the patient and clinician and is an understudied phenomenon, according to a study in the November issue of the Journal of Vascular Surgery: Venous and Lymphatic Disorders.

“Most reported data describing stent occlusion after venous intervention have included patients across the full spectrum of venous disease. Including patients with non-thrombotic disease and limited anatomic involvement as well as patients with more extensive disease has prevented the identification of specific variables relating to the outcomes for either group of patients separately,” said principal investigator William Marston

(University of North Carolina, Chapel Hill, USA).

“In this study, we investigated a patient cohort with venous outflow occlusion requiring recanalisation before stenting to determine the outcomes after intervention. We focused on the variables associated with early stent thrombosis in this high-risk segment of patients presenting with iliocaval outflow obstruction,” he continued.

Marston’s team retrospectively studied patients undergoing iliofemoral venous stenting at their institution (11 practitioners, two hospitals) from 2010 to 2020.

Only patients with type III (single segment) and type IV (multiple segment)

migration or fracture.

The VERNACULAR study involved 22 international centres enrolling 170 patients (93 post-thrombotic syndrome; 77 non-thrombotic iliac vein lesions).

Primary outcome measures were major adverse events at 30 days and 12-month primary patency (freedom from target vessel revascularisation, thrombotic occlusion, or stenosis >50%). Secondary outcomes included the VCSS pain assessment and hypothesis tested CIVIQ measurements. Secondary observations included primary patency, target vessel and lesion revascularisation (TVR/TLR), and assessment of stent integrity through three years.

Dake and colleagues emphasised that freedom from major adverse events through 30 days was 93.5%, statistically higher than a prespecified performance goal of 89% (p=0.032) while primary patency at 12 months was 88.6%, also statistically higher than a performance goal of 74% (p<0.0001). Mean quality-of-life measures were statistically improved compared to baseline values at one year (p<0.0001). Primary patency at three years was 84%, while freedom from TVR/TLR was 88.1%.

There was no stent embolization/migration, and no core laboratory assessed stent fractures reported at three years. “Six deaths were reported, but none adjudicated as device or procedure related,” the authors state.

Left: Venovo venous stent. Right: Zilver Vena venous self-expanding stent

iliofemoral venous occlusions observed three-year patency rates were were included. primary, 59%, and secondary, 76%.

A total of 106 patients were studied and Risk factors for early (within three had the following characteristics: months) stent thrombosis were: Age 50±14 years Type IV disease (odds ratio 4.6) Type III (41%) vs. type IV (59%) Hypercoaguable state (odds ratio 3.8) disease pattern Treatment with LMWH for Occlusion of the >10 days was associated with One fourth with known stented region lower odds (0.01) of early hypercoagulable state occurred in thrombosis.

Treatment included: Mean stent length “Patients with more 177±63mm extensive disease (type Antiplatelet therapy in IV) experienced a greater 53% incidence of thrombosis,” Anticoagulation in 95% said Marston. “Therefore, Anticoagulation involving studies that group nonLMWH thrombotic with - As a bridge (<10 post-thrombotic days) to warfarin patients who have (n=9), or undergone stenting - For 2–4 will be less able weeks before to identify the best transition to oral treatment protocols. anticoagulation “No consensus Primary Secondary (n=41) has been reached Anticoagulation regarding the optimal Three months with a direct oral postoperative following the procedure, anticoagulant anticoagulation occlusion of the stented (DOAC; n=39) therapy for these region occurred in 26%.

Three months patients. Our The observed three-year following the study suggests that patency rates were procedure, occlusion extended use of primary, 59%, and of the stented region LMWH reduces secondary, 76%. occurred in 26%. The early thrombosis.”

26%

4.5%

76%

December 2021 | Issue 84

26 Renal Interventions

WRAPSODY FIRST study demonstrates “very encouraging” 12-month results Twelve-month results from a first-in-human study of the Wrapsody cell-impermeable endoprosthesis (Merit Medical Systems) for the treatment of access circuit stenosis in haemodialysis patients are “very encouraging”. This is according to James Gilbert, a consultant transplant and vascular access surgeon at the Oxford University Hospitals NHS Foundation Trust in Oxford, UK, and pre of Britain & Ireland (VASBI), who presented these data for the first time at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2021 Summit (25–28 September, virtual).

G

ilbert noted that this first-in-human study— dubbed WRAPSODY FIRST—produced positive results in terms of safety, detailing that no adverse events confirmed as being device-related were observed in 39 patients at one-year follow-up.

Regarding effectiveness, he reported promising target lesion primary patency (TLPP) rates at 12 months across all lesion sites, in line with the study’s six-month data, and stated that access circuit patency rates also appear to remain high following treatment with the device.

Gilbert went on to detail the pivotal WRAPSODY WAVE trial—a global randomised controlled trial (RCT) that is currently underway to assess the Wrapsody endoprosthesis.

Speaking to Interventional News, Gilbert said: “The patients without any localised or systemic safety events 12-month effectiveness data, particularly of TLPP, are affecting the access or venous outflow circuit, and very exciting because we may have a stent that requires resulting in surgery, hospitalisation, or death, while the fewer reinterventions to maintain patency at the lesion primary effectiveness objective was TLPP. Follow-up site and, more importantly, ensures that the access took place at 30 days, three months, six months and 12 circuit remains functional—which is key for any dialysis months, he added. patient. The data were also reproducible at all lesion Gilbert stated that a total of 46 patients were sites treated within the access circuit, from enrolled in the study, with outcome data for the cephalic arch in a brachiocephalic 39 patients ultimately being available AVF [arteriovenous fistula] to the beyond one year. On safety outcomes graft vein anastomosis site and the at 12 months, he reported a total central veins. This is suggestive that of five adverse events, four of there is something about the stent’s which were adjudicated as being design, with its cell impermeable procedure-related, with the access middle layer and softened end circuit not being salvaged and a rows, that is key in minimising lack of imaging data making it edge stenosis at both ends of the impossible to determine if the one stent. remaining event—a thrombosed “We recognise that these very fistula—was device- or procedureencouraging data are only from a related. small, first-in-human study and so the Touching on effectiveness next, WRAPSODY WAVE trial will be key Gilbert described the 12-month TLPP in confirming just how good this rate of 84.6% as “very encouraging”, stent can be. The WAVE study will and similarly positive to the 97.7% not only provide a bigger number TLPP rate seen at six months, of patients in which to assess the before reporting that reintervention effectiveness of the stent, it will was successful in all problematic also provide experiences from a cases—resulting in a 12-month range of expert clinicians globally.” assisted TLPP rate of 100%. Further, Addressing the CIRSE audience, he noted an access circuit primary Gilbert described the Wrapsody patency rate of 65.9% at 12 months. All endoprosthesis as a “unique, tri-layered but five of the remaining access circuits stent graft” that is currently CE-marked for were salvaged via reintervention, he added, use in Europe and is available in sizes ranging from leading to a secondary patency rate of 88.6%.

6mm to 16mm, making it a viable treatment option These data are also published in CardioVascular for a “huge range” of stenotic lesions, including and Interventional Radiology (CVIR). those in the peripheral and central veins of an Gilbert concluded his presentation by conveying access circuit. details of the WRAPSODY WAVE trial, which is Gilbert went on to detail the design and purpose a multicentre RCT designed to further assess the of WRAPSODY FIRST—a prospective, threeWrapsody endoprosthesis as a treatment option centre, single-arm, first-in-human feasibility for dialysis access circuit stenoses and support study assessing the safety and effectiveness US Food and Drug Administration (FDA) Wrapsody of the device, for which he is the primary approval of the device. This trial is already endoprosthesis underway, and will involve 1:1 randomisation investigator. The subject population consisted of dialysis patients with AVFs or arteriovenous grafts of patients across two study arms comparing Wrapsody (AVGs) in their upper limbs, who experienced stenosis to percutaneous transluminal angioplasty (PTA)—in or occlusion within their access circuit. Gilbert reported addition to a third, registry-based arm assessing the the primary safety objective as being the proportion of device’s use at the graft-vein anastomotic site.

TCT 2021: Meta-analysis of randomised trials shows “consistent” reduction in blood pressure through renal denervation Randomised placebo-controlled trials show consistently that renal denervation provides significant reduction in ambulatory and office blood pressure, the findings of a systematic review and meta-analysis suggest.

FINDINGS OF THE PAPER, authored by Yousif Ahmad (Yale School of Medicine, Yale University, New Haven) and colleagues, were published in JACC: Cardiovascular Interventions and presented during an oral abstract session at the Transcatheter Cardiovascular Therapeutics annual meeting (TCT 2021, 4–6 November, Orlando USA and virtual).

The authors performed an updated

meta-analysis of randomised placebocontrolled trials of renal denervation and specifically compared the effect of renal denervation in patients taking medications and in those not taking medications. This included latest evidence from the RADIANCE-HTN TRIO trial, presented on the same day.

The study’s primary efficacy outcome was the change in ambulatory systolic blood pressure beyond the effect of the

84.6%

12-month target lesion primary patency rate

65.9%

12-month access circuit primary patency rate

placebo procedure, and analysis was stratified by whether there was background antihypertensive medication use.

Ahmad and colleagues report that there were seven eligible trials, totalling 1,368 patients.

Outlining the results, the study team notes that renal denervation significantly reduced ambulatory systolic

Denervation significantly reduced ambulatory systolic, ambulatory diastolic, office systolic and office diastolic blood pressure.”

(mean difference −3.61mmHg; 95% confidence interval [CI]: -4.89 to -2.33mmHg; p<0.0001), ambulatory diastolic (-1.85mmHg; 95% CI: -2.78 to -0.92mmHg; p<0.0001), office systolic (-5.86mmHg; 95% CI: -7.77 to -3.94mmHg; p<0.0001), and office diastolic (-3.63 mm Hg; 95% CI: -4.77 to -2.50; p<0.0001) blood pressure.

There was no evidence that the use of concomitant antihypertensive medication had a significant impact on the effect of denervation on any of these endpoints (p-interaction=NS for each comparison).

“Although the magnitude of benefit, about 4/2mmHg, is modest, it is similar between patients on background antihypertensive medications and those who are not.

Denervation could therefore be a useful strategy at various points for patients who are not willing to add antihypertensive agents,” the study’s authors note. “Whether the effect changes with time is currently unknown.”

Issue 84 | December 2021

Advertorial 29

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It is currently the only fully US Food and Drug Administration (FDA)-approved Y-90 radiation therapy in the USA for the treatment of colorectal cancer that has spread to the liver. The Y-90 resin microspheres can be delivered in a slow, deliberate manner, thereby helping to achieve an even distribution, thus maximising the number of microspheres delivered and Two experts in the field of interventional radiology, Bernhard Gebauer (head of optimising tumour coverage. interventional radiology at Charité – Universitätsmedizin Berlin in Berlin, Germany) Discussing some of the challenges associated with and Ahmed Kamel Abdel Aal (professor of interventional radiology at The University of many Y-90 programmes, Kamel states that “outcomes Texas Health Science Centre in Houston, USA) talk to Interventional News about their are often variable and not consistent. It can also take experience with SIR-Spheres Y-90 resin microspheres (Sirtex Medical)—which are used in some time between the decision for treatment and selective internal radiation therapy (SIRT) for certain liver tumours*—and discuss how this treatment with Y-90. This can delay other treatments advanced technology can help improve survival, boost patient quality of life (QoL) and and adds a lot of stress to the patient,” he continues. enable greater flexibility, customisation and speed of treatment.

However, there is a solution. Helping to address these challenges is Sirtex’s FLEXdose Delivery Real-world data Spheres Y-90 resin microspheres are an Programme, which Kamel says has helped Real-world data from the Cardiovascular option for a broad range of patients.” optimise his practice. He explains that the and Interventional Radiological Society He also outlines that oncological FLEXdose Delivery Programme provides of Europe (CIRSE) Registry for SIRfactors such as tumour size and number physicians with the opportunity to have one-, Spheres Therapy (CIRT)—which was presented at the of tumours, as well as the functional two- or three-day pre-calibrated vials which CIRSE 2020 Summit (12–15 September, virtual)— capacity of the liver “play a great role” contain exactly the same number of microspheres, showed that SIR-Spheres Y-90 resin microspheres were in determining the use of SIR-Spheres with different activity per sphere. associated with low 30-day mortality (1%) as well as a Y-90 resin microspheres.

Bernhard Gebauer “This offers you the flexibility to give the low incidence (2.5%) of serious adverse events (grade “Usually Y-90 treatment using SIRsame activity but with either more or fewer ≥3) within 30 days of treatment. Serious adverse events Spheres is used in patients where the microspheres, allowing you the ability to such as gastritis, gastrointestinal ulcerations, radiation tumours are not resectable or ablatable, customise treatment based on the tumour burden, cholecystitis and radioembolization-induced liver either because of tumour factors lobes and segments of the liver involved, and how disease occurred in less than 0.3% of the total patient (tumour too large, adherent to critical selective you are with your catheter,” says Kamel. cohort. organs or structures or invading vascular “Another advantage is the activity draw, which This large European registry, which included structures), remaining hepatic reserve is really very important in our programme and 1,027 patients, was designed to observe the real-life limitations (especially if large hepatic is very unique to SIR-Spheres. It allows you to Ahmed Kamel clinical application of SIRT with SIR-Spheres Y-90 resections are planned) or other patient administer a tailored and personalised activity resin microspheres and the impact of the treatment in factors or comorbidities that limit larger Abdel Aal for the patient’s specific needs. Imagine that on clinical practice. “The strength of CIRT registry data resections. Specifically, in the first the day of treatment you wanted a smaller dose is that they reflect patient and tumour treatment in a group (tumour factors) Y-90 SIRT could reduce the or another dose. You can draw the exact dose that you real-world scenario, including large treatment centres tumour volume and transfer the patient in a secondary desire from the vial. Being able to change the dose on and smaller hospitals from different countries and resectable or ablatable state. the day of the treatment means you do not have to keep healthcare systems,” says Gebauer.

“In selected cases, patients might benefit from an bringing the patient back again because you do not have In addition to highlighting low mortality and low earlier treatment with SIRT. SIR-Spheres Y-90 resin the right dose.” serious adverse events, the data also found that median microspheres show good response rates in localised “Previously, the usual sequence of events was to overall survival was 9.8 months (95% CI: 8.3–12.9) in map, do the dose calculation, order the dose and then 237 patients with metastatic colorectal cancer (mCRC). treat,” notes Kamel. “However, utilising Sirtex’s OrderThese figures from CIRT are “a great result for patients Map-Treat programme, you get a much faster patient with certain types of cancer who have limited options”, treatment.” adds Kamel.

“We know that we can always draw the exact dose Similar findings were reported in the CIRSE Registry we want and that is the beauty of this. It has also really for SIR-Spheres Therapy in France (CIRT-FR), the changed the mindset of our referring physicians because interim analysis of which revealed some interesting we can provide an accelerated treatment timeline data in relation to safety and patient QoL. There were that enables patients to be quickly returned to their a total of 200 patients (median age 66; 70% male) liver tumours and offer patients surgical options that medical oncologists for further systemic treatment(s)”, including 38 mCRC patients in the CIRT-FR registry. were unavailable before SIRT. concludes Kamel.

As was the case in CIRT, 30-day mortality was 1%.

“So patients could be transferred into a suitable A total of 12% of patients experienced at least one stage for resection or ablation and transferred into a *For full indication and prescribing information, adverse event within 30 days following treatment. In potentially curative stage. Depending on the location of please refer to the IFU at www.sirtex.com. relation to health-related QoL, which was assessed liver tumours SIRT allows various treatment strategies

using the EORTC QLQ-C30 questionnaire, the overall including segmentectomy, lobectomy and hemiablation Bernhard Gebauer is head of interventional radiology global health score remained stable between baseline with contralateral hypertrophy for resection”, he adds. at Charité – Universitätsmedizin Berlin in Berlin, (66.7%), treatment (62.5%) and the first follow-up “Preinterventional state-of-the-art imaging is Germany. He is German board certified in radiology (66.7%) essential for therapy planning”, says Gebauer, who and interventional radiology and specialised in IR “For heavily pretreated patients, the toxicity of a adds that “personalised medicine is nowadays the cancer treatment. treatment and QoL are very important”, says Gebauer, standard of cancer care and therefore the dosimetry adding that “the data show that SIR-Spheres Y-90 resin should also be so in order to improve the results of Ahmed Kamel Abdel Aal is a professor of microspheres are well tolerated and maintain patients’ SIRT.” interventional radiology and the chief of vascular and QoL.” He also explains that, with this technology, Kamel outlines how it is “important to realise that interventional radiology and the vice chair of radiology patients can be offered a chemo-free interval in order to each disease and each patient is different”. He agrees at The University of Texas Health Science Center at have the liver treated but without the side effects of a with Gebauer that, as a result, “treatment should be Houston (UTHealth) in Houston, USA. He is american systemic therapy. based on the goal of the therapy, the patient’s liver board certified in radiology and interventional function, the number and location of the lesions and the radiology and received his fellowship training in Patient selection prior, concurrent and future treatment(s). Personalised vascular and interventional radiology as well as Gebauer further discusses which patients can benefit dosimetry is always recommended for all patients neuroradiology at the University of Alabama most from this treatment, noting that, in general “SIRreceiving Y-90 SIR-Spheres”, he concludes. in Birmingham, USA.

We know that we can always draw the exact dose we want and that is the beauty of this.”

Issue 84 | December 2021

Market Watch 31

Product News vein access procedures

GPX embolic device

Innovative embolic device shows promise for interventional oncology drug delivery

Fluidx Medical Technology announced that a next-generation, doxorubicinloaded GPX embolic device was featured at the 2021 symposium on Clinical Interventional Oncology (CIO) conference highlighting the technology’s potential for oncology drug delivery.

“GPX is easy to prepare, deliver, and control,” said Ryan O’Hara (interventional oncologist, University of Utah, Salt Lake City, USA). “The initial results of GPX as a drug-loadable oncology solution are very promising.

GPX would be the first loadable liquid embolic designed for tumour applications.”

Study results presented at CIO included an in vitro characterisation of the loading and drug release profile of the GPX Embolic Material loaded with doxorubicin (GPX-DOX). GPX-DOX provided a zero-order release profile for five weeks and sustained release out to 100 days. The long linear release profile is desirable in drug delivery, as a constant amount of drug is delivered regardless of the concentration within the carrier. These properties are unique in the field of liquid embolics.

“The GPX embolic device is an innovative embolic designed for simple preparation and quick material delivery.

Its technology is a low viscosity, aqueous-based solution in a syringe that solidifies into a durable embolus upon delivery without polymerisation or dimethyl-sulfoxide (DMSO) precipitation, a press release from the company states. GPX is designed to occlude blood vessels independent of a patient’s coagulation situation. The device is packaged ready-to-use in a syringe, requires less than 30 seconds of tableside preparation by the clinician, and may be delivered through standard catheters or small microcatheters (no complex mixing systems or special delivery catheters are necessary), the release adds.

The GPX embolic device is under development and does not have marketing clearance or approval in any market at this time. For investigational use (in New Zealand) only.

Argon Medical launches novel innovations for portal

Argon Medical Devices has announced the launch of two portal vein access sets intended for transjugular liver access in diagnostic and interventional procedures.

The Scorpion portal vein access series addresses the common challenges physicians encounter when placing a transjugular intrahepatic portosystemic shunt (TIPS) or conducting other portal vein access procedures. The Scorpion series includes two sets, Scorpion and ScorpionX, which offer improved visualisation, revolutionary navigation control, and enhanced durability to augment existing procedural techniques, according to Argon Medical.

The Scorpion portal vein access series utilises a patented curve-in-curve system to offer physicians 360-degree range of motion with the needle or stylet used to access the portal vein. Each curved component can work together or independently to accurately steer the device through the liver to the intended target. Existing systems utilise only a single curve limiting the steerability of the needle or stylet. The Scorpion series’ novel design was created by Lowell Kahn, a vascular and diagnostic interventional radiologist located in Springfield, USA, in conjunction with Hatch Medical, the press release further outlines.

“Establishing access to the portal venous system is often the longest and most challenging part of many procedures. This is particularly true when the liver is diseased, making the anatomy irregular. I designed the Scorpion’s independently controlled dual curves to improve the physician’s ability to navigate through liver parenchyma and reduce the number of attempts necessary to establish access to the portal vein,” said Kahn.

The Scorpion portal vein access sets are currently available in the USA. Scorpion is licensed by Argon Medical and is a trademark of Hatch Medical.

HistoSonics receives FDA breakthrough device designation for novel sonic beam therapy

HistoSonics has revealed that the US Food and Drug Administration (FDA) has granted the company breakthrough device designation for its new histotripsy targeted liver therapy platform, which is designed to help provide timely access to non-invasive liver treatment.

HistoSonics notes that histotripsy of the liver provides clinicians with the first automated external beam therapy using acoustic energy to mechanically destroy and liquefy tissue in the liver without incisions, ionising radiation or heat.

The company believes the novel mechanism of action of their proprietary technology may offer significant

Rendering of HistoSonics treatment

advantages to patients, including equivalent treatment effect throughout the entire treatment volume resulting in precise and predictable treatment zones.

Early clinical and preclinical results also suggest that histotripsy largely preserves critical structures such as the liver capsule, and larger vessels and ducts within or adjacent to the treated volume of tissue.

In addition, histotripsy gives the treating physicians the ability to monitor the destruction of tissue under continuous real time visualisation and control, unlike any modality that exists today. The Breakthrough Designation will allow the company to engage with the FDA in a prioritised review during the regulatory market authorisation process, the company adds.

HistoSonics has worked with the FDA for over three years in developing preclinical and clinical data required for regulatory market authorisation and intends to continue collaborating with the agency throughout the ongoing Investigational Device Exemption (IDE) study, #HOPE4LIVER US, which is designed to evaluate the safety and technical efficacy of histotripsy in patients with primary and secondary liver tumours.

The HistoSonics system is investigational and is not available for sale in the USA or Europe.

Varian receives FDA breakthrough device designation for its Embozene microspheres

Varian, a Siemens Healthineers company, today announced that the US Food and Drug Administration (FDA) has granted the company breakthrough device designation for its Embozene microspheres for genicular artery embolisation (GAE) for symptomatic knee osteoarthritis.

Embozene is a medical device that is FDA cleared for the embolization of hypervascular tumours, arteriovenous malformations, uterine fibroids and benign prostatic hyperplasia.

According to Varian, Embozene microspheres received the designation due to their potential to offer a more effective treatment for appropriate patients with osteoarthritis of the knee. GAE is designed to reduce the blood flow to the periarticular tissue of the joints, limiting the inflammatory process.

Siddharth Padia, director of interventional radiology at UCLA Santa Monica and the David Geffen School of Medicine at UCLA, Santa

Monica, USA, said: “GAE is the first minimally invasive procedure that has demonstrated a significant symptom improvement for a prolonged duration.

“In a 40-patient, prospective study, the procedure resulted in a marked improvement in pain and function, and adverse events were uncommon and mild. I remain excited about the possibilities of this technology and its benefit to patients.” Padia is currently working to initiate a randomised clinical trial and a 400-patient registry.

The FDA breakthrough device program is intended to provide patients with more timely access to medical devices that have the potential to

Embozene microspheres

provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. As part of the program, the FDA expedites the traditional review and assessment process to help accelerate the development, assessment and review of the device for possible approval.

IceCure Medical announces updated regulatory strategy in China for the IceSense3 system to treat cancerous tumours with cryoablation

IceCure submitted an amendment to the registration certificate granted for the IceSense3 system by China’s national medical products administration (NMPA), which will allow IceCure to sell the IceSense3 and cryoprobes for commercial procedures in China.

IceCure Medical recently announced the advancement of the regulatory strategy in China with the submission of an amendment to the registration certificate for the IceSense3 system, which was granted by China’s NMPA. The amendment, if approved, will allow the company to sell the disposable IceSense3 cryoprobes for commercial procedures. The company expects the NMPA to evaluate the amendment by the end of 2022 and providing the amendment is approved, the company expects to then launch the commercial sales program for the IceSense3 system in China in early 2023.

The company also revealed that as part of its strategy to gain greater awareness of its systems and cryotherapy as a cancer treatment more broadly with healthcare providers in the region, that they have been supportive of an ongoing independent clinical trial with a site in Hong Kong and a site in Shenzhen. A press release also detailed that another independent trial is anticipated to start soon in a leading hospital in Shanghai.

Issue 84 | December 2021

Market Watch 33

Product News Medtronic receives CE mark approval for radial artery access portfolio

Medtronic today announced it has received CE mark approval for its radial artery access portfolio, which includes the Rist radial access selective catheter and the Rist 079 radial access guide catheter—the first catheter specifically designed for the unique demands of accessing the neurovasculature to treat stroke, brain aneurysms and other conditions through the radial artery versus access through the transfemoral artery, according to a company press release.

The Rist 079 radial access guide catheter is 510(K) cleared by US Food and Drug Administration (FDA) and has been in use at limited sites in the USA, receiving strong customer feedback in more than 100 cases on its outperformance in navigability and support for the radial pathway, the release adds.

“With excellent navigability, this first-of-its-kind device will allow clinicians to reach distal locations while still achieving excellent stability to the system,” said Alejandro Tomasello, head of the Interventional Neuroradiology Unit at Vall d’Hebron Hospital in Barcelona, Spain. “The radial artery access portfolio works well in tandem with Phenom PLUS, Phenom 021 microcatheter for stent deployment or Phenom 027 microcatheter for flow diverter deployment, which is a fantastic set up for the Pipeline Vantage embolization device with Shield technology treatments [all Medtronic].”

Transradial techniques have been the standard of care in the cardiac interventional community since the American Heart Association (AHA) recommended a radial-first approach for acute coronary syndrome in 2018, citing lower bleeding and vascular complications than transfemoral artery access.

Other advantages demonstrated in cardiovascular procedures to radial access include strong patient preference, immediate ambulation and reduced costs, which have led the neurointerventionist community to examine adoption of the transradial approach to their practice, the release also states.

Gore’s lower profile delivery Viabahn endoprosthesis gets EMEA launch Gore has announced the EMEA launch of the lower profile, large diameter Viabahn endoprosthesis with Propaten bioactive surface.

The device enhancements build on a market-leading stent graft device, which has become an important tool for treating complex vascular disease, Gore said in a press release. According to the company, the device design

Viabahn endoprosthesis

reduces the delivery profile for larger 9–13 mm diameter stent grafts by up to 3Fr, enabling delivery through smaller sheaths. Smaller introducer sheaths have resulted in a lower risk of vascular access complications in select patient populations.

New radiopaque markers, now also on the larger diameter device configurations, enhance visualisation under fluoroscopy, facilitating positioning and device delivery, as well as precise and predictable placement, the company adds.

“In addition to the radiopaque markers that facilitate positioning and deployment, the new lower profile enables use of a smaller sheath, potentially reducing the risk of damage at the access site,” said Manuel Alonso, vascular surgeon, Oviedo, Spain.

“Combined with the trackability and flexibility this new lower profile offering will become very instrumental for treating complex patients across disease states in my practice.”

BD announces 510(k) clearance of expanded indications for the Rotarex atherectomy system

BD recently announced it has received 510(k) clearance for expanded indications from the US Food and Drug Administration (FDA) for the Rotarex atherectomy system.

A press releae details that the Rotarex atherectomy system is a rotational excisional device that is built to remove and aspirate varying lesion morphologies including plaque and thrombus in the peripheral arteries. The Rotarex system, already cleared for use in native arterial vessels, now has the expanded indications to treat within peripheral arteries fitted with stents, stent grafts, and native or artificial bypasses, it adds.

“The Rotarex atherectomy system is quick and efficient for treating arterial

Rotarex atherectomy system

lesions,” said Prakash Krishnan, a cardiologist at the Icahn School of Medicine at Mount Sinai in New York, USA. “With ability to use it for both atherectomy and thrombectomy, it is now a great product to be able to treat in-stent restenosis. Rotarex has been a great device for me to have in my practice, and I am excited about these new indications.”

The FDA clearance of the Rotarex atherectomy system’s new expanded indications follows more than 10 years of real-world clinical experience involving the treatment of thousands of patients globally. Now, physicians can use a proven tool to address some of their most challenging peripheral arterial disease (PAD) lesions, including the treatment of in-stent restenosis.

“I have had the ability to use the Rotarex atherectomy system for over 10 years both within and outside the USA,” said Miguel Montero-Baker, a vascular surgeon at Baylor College of Medicine in Houston, USA. “This indication expansion is exciting and will allow me to utilise a device I trust to care for my complex PAD patients.”

Medtronic unveils data on hypertension treatment preferences, launches SPYRAL AFFIRM study

Medtronic announced findings from a new study of patient preferences for the treatment of hypertension. The findings were presented during the “What’s Novel in Interventional Hypertension” session at the Transcatheter Cardiovascular Therapeutics annual meeting (TCT 2021, 4–6 November, Orlando, USA and virtual).

Medtronic has also announced the initiation of the SPYRAL AFFIRM study, evaluating the long-term safety, efficacy, and durability of the company’s Symplicity renal denervation (RDN) system—which uses a minimally invasive procedure that delivers radiofrequency energy to specific nerves near the kidneys that can become overactive and cause high blood pressure—in real-world patients with uncontrolled hypertension and comorbidities, such as diabetes, isolated systolic hypertension and chronic kidney disease (CKD).

For the first time, new data presented at TCT 2021 will quantify US patient preferences for considerations of interventional procedures in the treatment of high blood pressure, including treatment mode, effectiveness and risks, according to a press release from the company.

The study found that, in exchange for treatment risks, patients on average would require a minimal acceptable benefit of less than 2.5mmHg reduction in office-based systolic blood pressure.

Additionally, on average, patients indicated a tolerance of at least 20% risk of adverse events (such as a vascular injury or drug side-effects) in exchange for being able to lower their office-based systolic blood pressure.

These findings suggest that, despite the risks of an intervention, patients

may accept lower blood pressure reductions than those observed in published literature of the Medtronic Symplicity Spyral RDN procedure.

Additionally, patients may be willing to tolerate risks higher than those observed in peer-reviewed published studies of Symplicity Spyral, the release adds.

The study also concluded that blood pressure reduction was the most important driver of patient preference over all other attributes like medication burden and treatment (including interventional treatment-related) risks.

When applying this model to a patient population that is interested in an interventional procedure without medication, up to 76.5% of patients would be willing to consider an interventional approach like RDN if they achieve a 10mmHg reduction in office-based systolic blood pressure.

Including the maximum acceptable risk of 20%: n 7 6.5% of patients would be willing to consider an interventional approach such as RDN with reductions in office blood pressure anticipated at 10mmHg n 24.3% of patients would be willing to consider an interventional approach such as RDN with reductions in office blood pressure anticipated at 5mmHg n 6.9% of patients would be willing to consider an interventional approach such as RDN with reductions in office blood pressure anticipated at 2.5mmHg, the minimal acceptable benefit “This novel, patient preference study is particularly valuable for a new procedure like RDN, because it demonstrates that, for patients, lowering blood pressure—even by a small amount—is meaningful,” said Michael Weber, professor of cardiovascular medicine at State University of New York, Downstate Medical Center (Brooklyn, USA). “For the first time, these results give us quantitative insights into hypertension treatment preferences—importantly, patients are very open to considering a medical intervention procedure, such as RDN, with demonstrated improvements in the control of their high blood pressure.”

The study, which was designed based on the US Food and Drug Administration (FDA) Guidance for Patient Preference Information, surveyed 400 individuals in the USA who have high blood pressure (physician confirmed systolic officebased blood pressure greater than 140 mmHg), who were on up to three antihypertensive medications, and were not previously involved in a SPYRAL HTN [hypertension] study.

Symplicity renal denervation system

December 2021 | Issue 84

34 Market Watch

Clinical News Medtronic launches SPYRAL AFFIRM study

Medtronic announced that the first patient was enrolled at Piedmont Heart Institute in Atlanta, USA, for the SPYRAL AFFIRM clinical study.

Using a performance goal, this clinical study will enrol 1,000 real-world patients with uncontrolled hypertension and associated comorbidities, such as isolated systolic hypertension, diabetes, and chronic kidney disease. SPYRAL AFFIRM will follow these patients for three years. This investigational device exemption (IDE) trial was approved by the US FDA in June 2021 and will be conducted at 100 sites globally.

The SPYRAL AFFIRM clinical study is part of the SPYRAL HTN Global Clinical Program, adding to the safety and efficacy data for RDN, the release continues. Along with the real-world data from the Global Symplicity Registry, when combined with commercial experience, there have been more than 20,000 procedures performed with Medtronic RDN technology. The clinical programme is backed by the most rigorous and extensive patient experience studied in the presence and absence of medication, and in patients with high baseline cardiovascular risk.

Phase 1 clinical trial of pembrolizumab immunotherapy plus cryoablation for inoperable mesothelioma underway

A phase 1 clinical trial for the treatment of patients with inoperable mesothelioma, with both pembrolizumab immunotherapy and cryoablation, has begun in New Jersey and New York, USA. Starting 24 September 2021, the trial is expected to be completed by September 2023.

Pembrolizumab immunotherapy enhances the ability of the immune system to detect and kill cancer cells. In patients with inoperable mesothelioma in the chest of the abdomen, researchers are trialing the addition of cryoablation within a phase 1 trial. Researcher Micheal Offin and co-investigators Marjorie Zaudere and Etay Ziv (all Memorial Sloan Kettering Cancer Centre, New York, USA) have therefore begun to investigate the treatment impact of drugs that strengthen the immune system such as pembrolizumab, plus cryoablation for inoperable mesothelioma.

This single group assessment is designed as a single-arm and singleinstitution study, with an estimated 10 patients recruited. All patients must be

over the age of 18 and have pleural or peritoneal mesothelioma that continues to grow despite previous treatment.

Eligible patients must be fully capable of self-care, with the exception of carrying out strenuous activities.

Patients who have received one previous line of systemic therapy which did not include pembrolizumab, are eligible for the study unless treated one year or more from the trial enrolment. Patients must also present a Karnofsky Performance Score (KPS) of ≤70% with adequate organ function. Eligible patients will receive one cycle of pembrolizumab (200mg/dose) delivered intravenously, followed by image-guided cryoablation of an ablation index lesion which will occur one to seven days prior to the start of cycle two. Cryoablation will treat a lesion with preference given to a lesion that is symptomatic or at risk of causing symptoms. Following institutional standards, complete ablation will be attempted. In addition, pembrolizumab will be continued for up to 24 months, unless disease progression, or intolerable toxicity. The number of patients with an adverse event defined as grade three or higher non-haematologic toxicity within 12 weeks of cryoablation will be the primary outcome measure.

Sirtex Medical and China Grand Pharmaceutical announce successful first administration of SIR-Spheres Y-90 resin microspheres in China

Sirtex has announced that the first procedure of selective internal radiation therapy (SIRT) using SIR-Spheres Y-90 resin microspheres in China was successfully performed for a patient with hepatocellular carcinoma (HCC) on 28 September 2021. The milestone was reached with the support of Sirtex shareholder China Grand Pharmaceutical and Healthcare Holdings Limited, a press release said.

The procedure was performed by Jiahong Dong (Boao Super Hospital, Hainan, China) and his team. Jiahong is a world-renowned specialist in hepatobiliary pancreatic surgery and liver transplantation and was elected Academician of Chinese Academy of Engineering in 2017, the release adds.

“The successful implementation of the first licensed access to the resin microsphere in the clinical treatment of liver cancer means that China’s liver cancer patients can receive international advanced selective in vivo radiation therapy,” said Jiahong Dong in a press conference. “This is a landmark and milestone in the history, ” he remarked.

SIR-Spheres

Issue 84 | December 2021

Market Watch 35

Industry News Experts launch ‘Masters of Circulation’ podcast

A trio of specialists in vascular surgery and interventional radiology recently launched a new podcast—‘Masters of Circulation’—with the aim of interviewing pioneers and leaders in the field of vascular intervention.

The podcast team consists of Ramon Varcoe, vascular surgeon at the Prince of Wales Hospital and associate professor of Vascular Surgery at the University of New South Wales (Sydney, Australia), Andrew Holden, director of Interventional Radiology at Auckland City Hospital and professor of Radiology at the University of Auckland (Auckland, New Zealand) and Peter Schneider, a professor of Surgery in the

Ramon Varcoe

Division of Vascular and Endovascular Surgery at the University of California San Francisco (San Francisco, USA).

Speaking to Interventional News, Holden hones in on the goals of the project, detailing a focus on “exploring the history of what got us to where we are now, the current challenges we are all facing and those all-important perspectives on where we are headed next”.

The group’s first interview with vascular luminary Frank Veith (New York University Langone Medical Center, New York, USA) “explored the early days of vascular surgery, the endovascular revolution, the struggles faced when embracing new technology, where the VEITHsymposium came from

Andrew Holden

Peter Schneider

Calendar of events 8–10 December 2021 British Society of Interventional Radiology (BSIR) Annual Scientific Meeting Glasgow, UK www.bsir.org

10–12 December 2021 Controversies in Dialysis Access (CiDA) Meeting Dallas, USA

www.dialysiscontroversies.org

14–15 January 2022 Spectrum 2022 Conference Miami, USA thespectrumconference.org

16–19 January International Symposium on Endovascular Therapy (ISET) Hollywood, USA www.iset.org

24–25 January MIO Live symposium Rome, Italy

www.10times.com/the-mio-livesymposium-rome

31 January–3 February Leipzig Interventional Course (LINC) Leipzig, Germany & virtual

www.leipzig-interventional-course.com

and how it has evolved over the last 48 years,” Varcoe writes on Twitter.

In another interview, Marianne Brodmann (Medical University of Graz, Graz, Austria) told the team about growing up on a farm in Austria and the path that led her towards becoming an angiologist. Brodmann “speaks with passion about what it is like to be a woman in a tough, male-dominated field and revisits the paclitaxel controversy three years later,” Varcoe remarks.

At the time of going to press, the team announced plans to speak with Michael Dake (University of Arizona Health Sciences, Tucson, USA), with more interviews to follow.

“Masters of Circulation” is available on all podcast platforms.

Varian appoints new vice president of Medical Affairs for Interventional Solutions

Varian has announce David Hahn (clinical assistant professor of Radiology, University of Chicago Pritzker School, Chicago, USA) joined the company as vice president of Medical Affairs for Interventional Solutions. As a leading, practicing interventional radiologist, Hahn will bring his extensive experience to Varian to help expand access to personalised, multimodal cancer care to patient populations worldwide.

“I am so excited to join the team at

Varian, and work with such a fantastic group of colleagues as we focus on ways to expand access to new and innovative interventional radiology methods,” said Hahn.

Sanford invents Breakthrough Device for vascular disease

An investigational device invented at Sanford Health (Sioux Falls, USA) that helps high-risk vascular disease patients has been granted a Breakthrough Device designation by the US Food and Drug Administration (FDA).

Patrick Kelly, a Sanford Health vascular surgeon, invented the aortic stent graft system designed to treat a thoracoabdominal aortic aneurysm (TAAA). Under a physician-sponsored investigational device exemption (PSIDE), he has treated more than 150 patients at Sanford Health over the past nine years who otherwise had no other options.

“This helps move the device through the regulatory pathway,” said Kelly.

“It opens the door for more patients to have an option for repair, even the potential for patients with aortic dissections, failed prior repairs and anatomies that were previously thought to be untreatable. The non-anatomical design allows broad applicability of our patient population.”

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.

3–7 February Society of Interventional Oncology (SIO) San Francisco, USA

26–28 April Charing Cross Symposium London, UK www.cxsymposium.com

11–16 June Society of Interventional Radiology (SIR) Boston, USA

2–6 March The European Congress of Radiology (ECR) Vienna, Austria

19–22 May Global Embolization and Oncology Symposium Technologies (GEST) New York, USS

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

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

23–29 May Canadian Association for Interventional Radiology (CAIR) Montreal, Canada

www.sio-central.org/SIO2022

www.myesr.org/congress/ecr2022

www.ecio.org

www.gestweb.org/gest/2022

www.sirmeeting.org

www.etconference.org

www.cairweb.ca

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