Interventional News Issue 78—July 2020 US Edition

July 2020 | Issue 78

A decade of PAE data demonstrates the procedure’s safety and efficacy: “Its time is now” Ten-year data published in Radiology show that prostate artery embolization (PAE) is a safe and effective treatment for men with benign prostatic hyperplasia (BPH), which can result in long-term improvements in lower urinary tract symptoms (LUTS) and quality of life. Francisco Carnevale (University of São Paulo Medical School, São Paulo, Brazil) and colleagues note that, prior to their study, long-term experience with PAE for BPH was “limited”. They state that this research is an “important contribution” towards the wider medical community’s understanding of PAE not as an experimental procedure, but “as another alternative for patients suffering from LUTS related to BPH”.

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arnevale and colleagues set out to evaluate the efficacy, safety, and long-term results of PAE for BPH through a retrospective, single-centre study. Between June 2008 and June 2018, a total of 317 men (mean age, 65±8 years) were treated with the minimally-invasive procedure for the alleviation of moderate to severe BPH-related symptoms. PAE was performed with 100–500μm embolic microspheres, and the investigators report a 100% technical success rate for the procedure.

Patient follow-up ranged from three months to 96 months (mean, 27 months). International Prostate Symptom Score (IPSS), quality-of-life score, maximum urinary flow rate, post-void residual volume, prostatespecific antigen (PSA), and prostate volume were all assessed at baseline and during follow-up. Mean maximum improvement was as follows: IPSS, 16±7 points; quality-of-life score, 4±1 points; prostatic volume reduction, 39±39cm3 (39%±29); maximum urinary flow rate, 6±10mL/sec (155%±293); and post-void residual volume, 70±121mL (48%±81) (p<0.05 for all).

Early clinical failure occurred in six (1.9%) and symptom recurrence in 72 (23%) men at a median follow-up of 72 months.

Unilateral PAE was associated with higher LUTS recurrence (42% vs. 21%; p=0.04), but the study authors note that the unilateral PAE cohort were on average slightly older than those treated with bilateral PAE (71 years old vs. 65 years old). However, log-rank analysis comparing unilateral and bilateral PAE groups showed no statistically significant difference in the median time to recurrence (48 months and 72 months, respectively; p=0.19).

Embolic particle size did not relate to symptom recurrence, with no difference observed in the median time to recurrence among men treated with microspheres 100–300μm or 300–500μm in diameter.

Baseline PSA was inversely related with recurrence, and was found to be an independent predictor of recurrence outcomes after PAE (hazard ratio [HR], 0.9 per nanograms per millilitre of PSA; 95% confidence interval [CI], 0.8, 0.9; p<0.001).

None of the patients presented with urinary incontinence or erectile dysfunction, an “important finding”, according to Carnevale.

Speaking to Interventional News, Carnevale stresses the significance of this research, the first decadelong dataset to follow-up outcomes in over 300 PAE

Francisco Carnevale

patients: “It was published in the most reviewed journal with the highest impact factor in the radiology field. Urological societies have been waiting for these long-term data to decide if [they trust that] PAE can be offered as another alternative treatment for patients suffering from LUTS related to BPH. These data consolidate the pioneering, multidisciplinary work done by the Radiology and Urology Departments at the University of São Paulo Medical School. Without this mutual collaboration, this important contribution would not be achieved.

“To bring a new, alternative treatment to the medical community is not an easy assignment,” he continued.

“This 10-year experience of using PAE confirms that this minimally invasive procedure is not only an alternative for candidates suffering from LUTS due to BPH-enlarged prostates. Several publications from different centres all over the world have shown that

To bring a new, alternative treatment to the medical community is not an easy assignment.”

Continued on page 2

Bill Rilling:

Profile

Page 16

Afshin Gangi:

CIRSE and COVID-19 Page 20

IR beyond COVID-19 The COVID-19 pandemic has greatly impacted every facet of medicine, with the initial spread of the SARS-CoV-2 virus overwhelming many healthcare services.

Now with several months’ experience treating COVID-19 patients, and following the mitigating effects of global travel restrictions and government-imposed “lockdowns”, many interventional radiologists are looking to the future, attempting to ascertain how their service may have been irrevocably altered.

AMIDST THE INITIAL chaos of cases that besieged hospitals in the early Spring, Italian oncologists Filippo Pietrantonio and Marina Chiara (both Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy) chronicled their dawning realisation of the severity of the pandemic in the Journal of the American Medical Association (JAMA) Oncology: “At this moment, we feel unprotected. Although everyone in the newspapers is praising physicians as heroes, we feel alone, thrown into jeopardy, thrown into an abyss. Our region has left us to fight the cancer battle and the COVID-19 war without true protection.”

However, those early months—characterised by the scramble for personal protective equipment (PPE), the cancelling of electives, and the segregation of hospitals into COVID-positive and COVID-negative work spaces—have taught much.

William Rilling (Medical College of Wisconsin, Milwaukee, USA) expressed to this newspaper: “I think that IR as a specialty has stepped up and shown that we can respond to a public health crisis. Much of our efforts during the pandemic were to support our colleagues in the intensive care unit, forming teams to perform portable urgent procedures if necessary during the surge of COVID-19 patients. Much of our interventional oncology (IO) practice has continued as usual during the pandemic. Globally, I think there has been a shift in some regions toward increased IO treatments, which use fewer hospital resources, PPE, and probably also [have] less decrement in the immune system compared to surgery. Over the long term, some of these advantages may result in changes in practice patterns; for example, there has been an increase in overall Y90 treatments in the USA during the pandemic—we do not know if this trend will last.”

For more on COVID-19 and IR, see pages 19–22.

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Prostate artery embolization

A decade of PAE data demonstrate the procedure’s safety and efficacy: “Its time is now” Continued from page 1

PAE has been accepted with excellent results for patients with urinary retention, for BPH-related bleedings, for patients with contraindications to traditional surgical treatments, and for patients with different prostate sizes (small and huge prostates). Now, PAE can be looked at with different eyes. Over the last decade, we have followed every ethical committee approval (local and national) and have followed several lines of inquiry (including investigating different prostate sizes and symptoms, as well as various embolic agent types and sizes). In this Radiology publication, we have included all patients during our ‘learning curve on PAE’. This means that, among all published patients following different prospective trials, we have tested and learned with every single patient and procedure. We were trying to identify the best way to perform PAE. It was really new and challenging to us.”

PAE excluded from urology guidelines globally

In March 2016, the Conselho Federal de Medicina (CFM), the authority in charge of professional regulation and medical licensing in the country, stated that PAE can be used as a new, alternative treatment for symptomatic patients with BPH. However, the body noted that five-year results should be analysed before a final decision is made on the procedure’s inclusion in the national urology guidelines. “Now, after 12 years of PAE and with this 10-year follow-up data, it is time the CFM gives the final approval for PAE,” comments Carnevale. “With that obtained, we hope the Brazilian Urological Society will include PAE in its guidelines for the treatment of BPH.” This is a global issue. In 2018, results of the UK ROPE study, which compared embolization to

The publication of these exciting results from our 10-year experience of PAE is a great achievement, and should be considered by the medical community.”

July 2020 | Issue 78 conventional prostate surgery, led the National Institute of Health and Care Excellence (NICE) to determine that the evidence on the safety and efficacy of PAE for BPH was adequate to support the use of this procedure on the National Health Service (NHS). They recommended the procedure “provided that standard arrangements are in place for clinical governance, consent and audit”. NICE added: “This technically demanding procedure should only be done by an interventional radiologist with specific training and expertise in PAE”.

Nevertheless, the European Association of Urology (EAU) guidelines for the diagnosis and treatment of men with LUTS/BPH have not been updated, and remain cautious when describing the potential clinical role of PAE. They state: “A multidisciplinary team approach of urologists and radiologists is mandatory as the basis for future randomised controlled trials of good quality with long-term follow-up in order to integrate this treatment option into the spectrum of efficient, minimally invasive treatment options.” Since then, a 2019 study published in European Urology from Tiago Bilhim (Hôpital Saint-Louis, Lisbon, Portugal) et al has demonstrated that improvements in quality of life measurements and IPSS are “far superior” following PAE than due to any placebo effect.

A US Food and Drug Administration (FDA) review in 2017 concluded that “the probable benefits outweigh the probable risks for this indication”, and in June the same year, the indication of Embosphere microspheres (Merit Medical) was expanded through the FDA’s 513(f)(2) de novo classification to include PAE. In 2018, the product was approved for the same indication by a 510(k) pathway. Embozene microspheres (Boston Scientific) also gained an expanded indication in 2018, with the FDA granting approval for its on-label use in PAE treatment in the USA via the 510(k) pathway. However, PAE is not recommended outside of a clinical trial in the American Urological Association (AUA) guidelines, something many interventional radiologists refute.

Addressing doubters of PAE, Carnevale says: “According to the Hippocratic oath, physicians should ‘Apply dietetic measures for the benefit of the sick according to their ability and judgment’. Interventional radiologists have faced turf battles for decades when aiming to bring new, alternative treatments for patients.

This happened with peripheral angioplasty, fibroid embolization, and abdominal aortic aneurysm repair, among others, and it will not be any different with PAE. We are not saying that PAE is the only or the best treatment for LUTS related to BPH. We have simply brought another option for patients and physicians to discuss. Each treatment has its indications and contraindications, and it is necessary to understand the patient’s aims and wishes. The publication of these exciting results from our 10-year experience of PAE is a great achievement, and should be considered by the medical community. Its time is now.”

News in brief

The latest stories from the interventional world

n REDUCING THE RISKS OF NON-TARGET EMBOLIZATION IN PAE: As the leader of an investigatorinitiated, Phase 2 study evaluating the safety and efficacy of the SeQure microcatheter (Guerbet), Francisco Carnevale outlines his experience using the device, drawing particular attention to the reduced risk of reflux and non-target embolization.

For more on this story go to page 13 n BALLOON-EXPANDABLE COVERED STENT REVEALS PROMISE AS ENDOVASCULAR ALTERNATIVE TO SURGERY IN TREATMENT OF ARTERIAL EMERGENCIES: Maria Antonella Ruffino, a vascular interventional radiologist at Azienda Ospedaliera Universitaria Città della Salute e della Scienza in Turin, Italy, tells Interventional News about her team’s growing clinical experience with covered stents as a platform that offers a minimally invasive solution for arterial emergencies.

Ruffino gives an insight into the advantages of covered stents in such cases, their potential limitations, and which stents may be a favourable option for emergency treatment.

For more on this story go to page 19. n INTERVIEW WITH THE CIRSE PRESIDENT : “Europe, including the European Union (EU) and the leaders of its nation states, needs to prepare better for future pandemics. I think we must develop a Europe-wide contingency plan providing clear guidance on effective measures,” says Afshin Gangi, president of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE). Speaking with this newspaper, he outlines the society’s response to the coronavirus pandemic, as well as measures taken by his own institution.

For more on this story go to page 20.

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Transarterial radioembolization

July 2020 | Issue 78

Radioembolization paper publication a “landmark moment” for IR-Hepatology collaboration The cover of June’s edition of the Journal of Hepatology featured a paper on transarterial radioembolization for the treatment of hepatocellular carcinoma (HCC). Publication of the paper, authored by Riad Salem (Department of Radiology, Northwestern University, Chicago, USA) and colleagues, has been described as a “milestone” for interventional radiology (IR) as a specialty and has heralded a call for greater collaboration between interventional radiologists and their hepatology colleagues.

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n the paper, Salem and colleagues investigate lung shunt function (LSF) observed in early HCC, and provide the scientific rationale for eliminating this step from routine practice. Salem and colleagues found that early stage patients, where segmental injections are planned, exhibited low lung shunting, effectively eliminating the risk of radiation pneumonitis. The study team proposed that the lung shunt study be eliminated in this subgroup, leading to fewer procedures, a cost reduction, and improved convenience for patients.

Commenting on the clinical implication of eliminating lung shunt function in early HCC patients from routine practice, Salem tells this newspaper that “this would streamline the Yttrium-90 [Y90] algorithm, decrease the time to treatment, lower costs and minimise unnecessary hospital visits.” He continues: “This is particularly important in the time of COVID-19. Basically, we could take a patient selected for segmental Y90 at tumour board, schedule the procedure, and treat. This model also gets us one step closer to our ultimate goal of the ‘one-hour Y90’ as the standard of care.”

Julius Chapiro, co-director of the Interventional Oncology Research Laboratory at Yale School of Medicine, New Haven, USA, speaks to Interventional News about the publication of the data. “The importance of publishing such data in the Journal of Hepatology and being featured as the cover story cannot be overstated for all of IR,” Chapiro comments. He cites the words of IR pioneer Charles Dotter, calling upon the practice to “provide clinical care” and “own” diseases and patients.

“If we fail to do so,” Chapiro says, paraphrasing Dotter, “[we] become nothing more than high-priced plumbers”.

According to Chapiro, the manuscript takes these words from Dotter directly to heart. “Those of us who advocate for interventional oncology as the fourth pillar of cancer care must be rooting for Riad Salem’s team and this achievement,” he says. “Such high profile publications are changing clinical paradigms and inform a broad variety of specialists involved in therapy of liver cancer. The Journal of Hepatology is the official outlet of the European Association for the Study of the Liver (EASL) and has the highest impact factor of all journals focusing on liver disease. The publication reaches tens of thousands of people across the globe, including medical and surgical oncologists, both academic and in private practice. Having an IR cover story highlight our entire profession with such prominence legitimises our efforts, advocates for our therapies, establishes unquestionable authority, and protects our specialty.”

Describing the publication process, Salem says: “Once we had selected the prestigious Journal of Hepatology as our target, the manuscript was formatted accordingly and submitted. After receiving generally positive comments, we were encouraged to submit a revision with specific queries addressed. Once it was accepted, their production team sprang into action and enhanced the presentation style and graphics. They are a worldclass team that significantly improved the manuscript

quality, with the end result of the journal cover.

“The field of hepatology is supremely competitive.

Research groups from all around the world compete for a place in their high impact journals, with the Journal of Hepatology as one of the leaders, with an impact factor of 19. If the research is novel, impactful, and advances the field, the editors are universally fair and provide opportunities for all disciplines to publish in their journal. I have been very fortunate that in my career advancing IR, 26 manuscripts have been published in the highest impact journals of Gastroenterology, Hepatology, Journal of Hepatology and Gut. The editors placing our study on the cover reflects an acknowledgment of our team dedicating years of hard work investigating new concepts and challenging dogma. Our research group is humbled and honoured by this prestigious recognition.”

IR/Hepatology collaboration

Discussing the efforts being made to improve teamwork between hepatologists and interventional radiologists, Chapiro comments that interventional radiologists are an integral part of liver tumour boards across most academic institutions, and that there has been a growing appreciation of their

Those of us who advocate for interventional oncology as the fourth pillar of cancer care must be rooting for Riad Salem’s team and this achievement.” role in treating cancers of the liver. “Hepatologists and medical oncologists, who mostly lead those tumour boards in their cancer centres, have come to appreciate interventional oncologists as valuable team members and the spirit of those interactions is usually collaborative, productive, and cordial,” Chapiro states.

However, he argues that one of the most prevalent issues for interventional radiologists during these interactions with hepatology colleagues is the lack of unequivocal data in support of the therapeutic options.

“This is especially true for the relative paucity of prospectively collected data from randomised controlled trials that would support the use of Y90, for example, in lieu of chemoembolization or as an option for patients with advanced stage disease.” Although not a randomised controlled trial, the data from Northwestern published in Journal of Hepatology on the use of Y90 in early stage disease in patients waitlisted for transplant

is an extremely valuable piece of information and has huge practical value, Chapiro suggests. “The elimination of shunt studies will make it more likely for transplant hepatologists and medical oncologists to choose this therapy, now that it has the stamp of approval from Jorunal of Hepatology. Such data represent an important bridge between IR and other members of the tumour board.”

Exploring this idea further, Chapiro’s abiding message is that “teamwork begins at home”. “Our own institution has a very productive liver centre and interventional radiologists participate as full and associate members in collaborative projects and National Institutes of Health [NIH]-funded research,” he says, adding that other avenues to collaborate are certainly through participation in National Comprehensive Cancer Network guidelines, and through active memberships in national and international societies such as the American Association for the Study of the Liver (AASLD), EASL and several Asian societies. Looking ahead at the opportunity for further opportunities to collaborate, he called for interventional radiologists to continue to make their voices heard within hepatology practice. “It is key for us to be present at their annual meetings and invite them to our own platforms such as the Society of Interventional Oncology Annual Meeting. At the end of the day, all we care about are patient outcomes and there is no better glue for us than this shared responsibility.”

Journal of Vascular and Interventional Radiology impact factor passes 3 The impact factor of the Journal of Vascular and Interventional Radiology’s (JVIR)—one measure of a journal’s influence based on the number of article citations compared to the total number of citable articles published—has broken 3 for the first time.

According to the Journal Citation Reports, from Clarivate Analytics, JVIR’s Impact Factor rose 7% to 3.037 in 2019, up from 2.828 in 2018.

“This spectacular leap to the 3 range places JVIR in a distinct new class of peer journals, outdistancing all interventional radiology [IR] specialty journals,” comments Ziv J Haskal (University of Virginia School of Medicine, Charlottesville, USA), the editor-in-chief of JVIR. “This continuing growth trajectory makes JVIR the commanding voice of IR science and the home of the highest-level IR research on its pages.

“I have personally nudged, encouraged, curated, and sometimes ruthlessly edited over 17,000 manuscript drafts at all stages in a decade of living JVIR. The quality of our science has methodically and consistently improved, reflecting the pole position of this specialty in modern medicine. I could not be happier.”

“More than ever, there is a clear need for sound science and strong data to deliver optimal care for patients,” says Society of Interventional Radiology president Michael D Dake (University of Arizona Health Sciences, Tucson, USA). “The research published in JVIR provides the support for image-guided therapies that interventional radiologists need to improve the lives of their patients.”

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SIR Virtual coverage

July 2020 | Issue 78

Study demonstrates feasibility of hologram technology in liver tumour ablation Data from one of the first clinical uses of augmented reality guidance with electromagnetically tracked tools show that the technology may help doctors quickly, safely, and accurately deliver targeted liver cancer treatments, according to a research abstract presented during a virtual session of the Society of Interventional Radiology’s 2020 Annual Scientific Meeting (13–14 June). The technology provides a three-dimensional holographic view inside a patient’s body, allowing interventional radiologists to accurately ablate tumours while navigating to avoid critical structures.

“CONVERTING TRADITIONAL two-dimensional imaging into threedimensional holograms which we can then utilise for guidance using augmented reality helps us to better view a patient’s internal structures as we navigate our way to the point of treatment,” says Gaurav Gadodia, lead author of the study and resident at Cleveland Clinic (Cleveland, USA).

“While conventional imaging like ultrasound and CT is safe, effective, and remains the gold-standard of care, augmented reality potentially improves the visualisation of the tumour and surrounding structures, increasing the speed of localisation and improving the treating-physician’s confidence.”

In this initial in-human pilot study, the technology was used to deliver a treatment known as percutaneous thermal ablation of solid liver tumours.

To apply this technology, the physicians use multi-phase CT to coordinate markers placed on a patient’s body. This imaging data is added to a software application that allows for segmentation of the tumour and nearby structures within the marked coordinate space.

This information is fed into a proprietary augmented reality application, which utilises Microsoft’s HoloLens technology, a virtual reality headset with transparent lenses, to project a segmented hologram of the patient’s imaged anatomy directly onto the patient. The hologram is registered to the coordinate markers to ensure accurate location of the relevant anatomy.

Utilising electromagnetic tracking, instruments including the ablation probe can also be visualised in the augmented reality space during the procedure, thus allowing for true holographic

intraprocedural guidance. Interventional radiologists can then use the combination of the holographic images of the patient’s anatomy and tracked tools to find the tumour in the patient’s liver quickly, check for optimal targeting of the tumour by the ablation probe, and avoid key structures.

The study included five patients who were selected for microwave ablation of their liver tumours. For safety during this Institutional Review Board (IRB)approved study, the gold standard of ultrasound was used for primary clinical decision making and probe guidance, with direct comparison to holographic guidance. Following ablation, images and video from post-procedural sonography,

We can change 2D images into holograms of a patient’s distinct anatomy.” cone beam and multi-detector row CT, and HoloLens recordings were evaluated.

In all five cases, intra-procedural holographic guidance was in agreement with the standard ultrasound-based guidance. Post-procedural imaging showed adequate tumour ablation, and no patients experienced tumour recurrence at the three-month follow-up. In this early phase pilot study, the authors anecdotally

Transarterial chemoperfusion is safe and feasible in advanced mesothelioma A novel treatment for advanced mesothelioma is safe and effective and may improve the quality of life for patients who have few treatment options, according to a research abstract presented during a virtual session of the Society of Interventional Radiology’s 2020 Annual Scientific Meeting (13–14 June). Transarterial chemoperfusion with cisplatin, methotrexate, and gemcitabine every four weeks is a feasible and safe treatment for patients with relapsed unresectable malignant pleural mesothelioma (MPM). It comes with minimal side effects and shows promise for extending the lives of patients who have limited or no remaining treatment options.

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nterim results from a phase 2 prospective study were announced at the SIR Virtual Meeting during an Abstract of the Year session. Presenting on behalf of his fellow researchers, Bela Kis (Moffitt Cancer Center, Tampa, USA), principal investigator of the study, said that the treatment shows a promising disease control rate in heavily pre-treated patients with relapsed MPM. “MPM is a devastating cancer of the pleura, the membranes surrounding the lungs, that is very difficult to treat,” Kis said. “The typical survival rate of patients with stage 3 and 4 MPM is around 12 months from diagnosis; but with this new treatment, we are hoping we might be able to extend patients’ lives beyond that— giving them more time with friends and family.”

He explained that advanced MPM carries a poor prognosis, and that transarterial chemoperfusion treatment selectively delivers a relatively high concentration of chemotherapy to the targeted tissue’s arterial bed, maximising antitumoural effect and minimising systemic side effects. The study is investigating the disease control rate, overall survival

and adverse events of the treatment in patients with relapsed unresectable MPM. In all, 27 patients with MPM —four females and 23 males, mean age 70.8±6.8 years—were enrolled between March 2016 and June 2019. Patients had transarterial chemoperfusion treatment in every four weeks with cisplatin (35mg/m2), methotrexate (100mg/m2), and gemcitabine (1000mg/m2) via the ipsilateral internal mammary artery and/or descending thoracic aorta. All patients had received and progressed on prior chemotherapy. Four patients had also had radiation therapy, and three patients had had pleurectomy. Response rate was evaluated by modified RECIST for mesothelioma.

Transarterial chemoperfusion delivers a relatively high concentration of drugs to diseased tissue in the

observed that the speed of tumour localisation was faster with holographic guidance, and that their confidence in optimal ablation and critical structure avoidance was improved over standard imaging guidance. They are attempting to quantify these findings as they continue to enrol patients in the study.

Beyond its use during treatments, interventional radiologists also see value in using this tool for clinicians’ planning purposes and for improving patient engagement and understanding of the condition and treatment.

“This technique can be used intraprocedurally to check the accuracy and quality of the treatment, as well as preprocedurally to engage with the patient in their own care,” says Charles Martin, an interventional radiologist at Cleveland Clinic who is the principal investigator of the IRB and the senior author of the study. “We can change 2D images into holograms of a patient’s distinct anatomy so that both the physician and the patient get a better understanding of the tumour and treatment.”

Researchers continue to test this technology for ablations in the abdominal area with plans to expand to other types of procedure and in other areas of the body. The technology has only been tested for feasibility and therefore cannot yet be used as a standalone method for delivering a treatment.

This work was funded through internal enterprise grants from Cleveland Clinic, as well as the biotechnology start-up, MediView.

lining of the lungs to maximise the treatment effect with limited side effects. Unlike other chemotherapy that is delivered intravenously and circulates through the entire body, interventional radiologists inject one-third of the chemotherapy cocktail of cisplatin, methotrexate, and gemcitabine directly into the internal mammary artery that supplies the pleura. The other two-thirds of the drugs are injected into the descending aorta, which reaches the intercostal vessels that also supply the pleura. The treatment is an outpatient procedure and typically lasts an hour, followed by a one-hour recovery.

The interim results of the study show 70.3% disease control rate and median overall survival rate of 8.5 months from the start of the chemoperfusion treatment.

The treatment was well-tolerated by patients with a major complication rate of 1.4%. Most side effects were relatively minor, including mild nausea and chest pain.

“We were pleasantly surprised to find that this treatment doesn’t come with the same side effects of traditional intravenous chemotherapy,” said Kis. “To see these promising results with so few side effects means we are able to make a positive impact on quality of life for these patients.”

Currently, surgery is the only truly effective treatment for MPM, but the disease must be diagnosed early. Only 10–20% of patients are candidates for surgery and often experience surgical complications.

The researchers are looking to expand their study to other cancer centres with larger MPM patient populations, since the cancer is so rare. They also hope to add flexibility to the study to allow for increasing the dosage and changing the combination of medications for individual patients to determine whether either approach could further improve outcomes.

SIR Virtual coverage

Issue 78 | July 2020

Arterial embolization of the shoulder improves adhesive capsulitis patients’ pain and function A new, nonsurgical treatment decreases errant blood flow in the shoulder to quickly reduce pain and improve function in patients with adhesive capsulitis, also known as “frozen shoulder,” according to a research abstract presented during a virtual session of the Society of Interventional Radiology’s 2020 Annual Scientific Meeting (13–14 June).

Frozen shoulder gradually causes significant pain and stiffness of the shoulder joint in an estimated 200,000 people in the USA each year. The symptoms are often treated with physical therapy or pain medications, until they resolve within one to three years.

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atients with frozen shoulder are essentially told to tough it out until their symptoms improve, but considering the significant pain and decreased function many experience, we looked to determine if this treatment model of embolization, already in use in other areas of the body, could provide immediate and durable relief,” comments Sandeep Bagla (Vascular Institute at Virginia, Woodbridge, USA), CEO of Vascular Interventional Partners, NOVA, and lead author of the study. “We were shocked at the profound and dramatic improvement patients experienced in pain and use of their shoulder.”

In this Phase II US Food and Drug Administration (FDA)-approved Investigational Device Exemption clinical trial on arterial embolization of the shoulder (AES), interventional radiologists inserted a catheter through a pinhole-sized incision in patients’ wrists that was used to feed microsphere particles into as many as

six arteries in the shoulder to reduce inflammation. The treatment was conducted on an outpatient basis and took approximately one hour. Each patient’s pain, disability, and blood flow in the shoulder were measured before and after the treatment using three scales, in addition to magnetic resonance imaging (MRI) to visualise the shoulder joint.

We were shocked at the profound and dramatic improvement patients experienced in pain and use of their shoulder.”

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The treatment was successfully completed in 16 patients whose symptoms had not responded to conservative treatment over 30 days.

Minor adverse events, such as temporary skin discoloration, were reported Sandeep Bagla in nine patients. One month later, researchers followed the progress of 11 patients and found that pain significantly decreased after arterial embolization of the shoulder (-57mm on the Visual Analog Scale) and improved physical function in all patients (+28mm on the Single Assessment Numeric Evaluation and +30mm on the American Shoulder and Elbow Surgeons Shoulder Score). Additional progress was reported at three-month follow-up.

“We are early in the investigation of this treatment but are inspired by its effectiveness in reducing pain and range of motion in patients’ shoulders,” Bagla says.

The research was conducted as a collaboration between interventional radiology and orthopaedic surgery to build on international studies of the procedure by adapting the treatment design and embolic agent to be more durable. The team plans to expand the study to additional patients in 2020.

The authors note that this treatment is still investigational and that conservative therapies should still be considered first. Additionally, there are several important limitations of the research, including small sample size and lack of control arm.

House-call model tapping interventional radiology improves outcomes and access to care Interventional radiologists participating in a collaborative house call model in rural Indiana, USA, helped reduce emergency department use by 77% and hospital readmissions by 50% for nearly 1,000 elderly homebound patients with chronic illnesses, according to a research abstract presented during a virtual session of the Society of Interventional Radiology’s 2020 Annual Scientific Meeting on 13 June. The novel care model brings interventional radiology treatments into patients’ homes to provide more value through inhome advanced specialty care, prevent common complications of chronic diseases, and avoid unnecessary emergency department visits and hospital admissions.

“OLDER HOMEBOUND PATIENTS, including those in nursing home settings, have few resources available to receive specialty care and often delay care until preventable issues become urgent and acute,” explains Nazar Golewale, lead author of the study and an interventional radiologist with Modern Vascular & Vein Center (Valparaiso, USA). “By providing image-guided treatments in a patient’s home, we are improving access to care that otherwise would need to be delivered in the hospital.”

Golewale sees more than 900 of the practice’s patients to diagnose and manage their conditions. Through varieties of portable technology, he brings interventional radiology care into patients’ homes that would normally be delivered in clinics, such as ultrasoundguided needle biopsy, paracentesis and thoracentesis, ultrasound-guided joint

injections for pain, wound care, and drug infusions.

Payments for care are covered

by Medicare reimbursement Nazar Golewale for homebound patients.

The care partnership was formed to overcome the difficulty of providing specialty care for chronically ill, homebound patients in Golewale’s rural community. As a result of the programme, patient satisfaction scores increased from 17% to 84% from before and after implementation of the programme. Primary care providers, including internists and nurse practitioners, recruited specialists based on the needs of the patients they serve. In addition to interventional radiology, the

house call practice includes providers in internal medicine, podiatry, laboratory services, and wound care.

“Some specialty services are available at our local hospitals, but cost-effective ways of coordinating

patients’ transportation and visits remained a significant barrier to care,” says Golewale. “By bringing the hospital care to the patient, we are eliminating these hurdles and providing timely, personalised care.”

New SIR president Michael D Dake (University of Arizona Health Sciences, Tucson, USA) has become the new president of the Society of Interventional Radiology (SIR).

HE OFFICIALLY ASSUMED his new responsibilities after the annual members’ business meeting of the society, which was held this year via a webinar.

Other officers of SIR’s 2020-2021 executive council include: President-elect: Matthew Johnson (Indiana University

School of Medicine, Indianapolis, USA) Secretary: Parag Patel (Medical College of Wisconsin, Milwaukee, USA) Immediate past-president: Laura Findeiss (Emory University School of Medicine, Atlanta, USA)

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Peripheral interventions

July 2020 | Issue 78

COMPARE trial highlights efficacy of low-dose paclitaxel balloons

CX 2020 LIVE addresses ongoing investigation into paclitaxel safety The first session of CX 2020 LIVE saw participants from Stockholm to Santiago asking questions and engaging with leading vascular figures on the ongoing investigation into the safety of paclitaxel devices in the treatment of peripheral arterial disease (PAD).

ROGER GREENHALGH (LONDON, UK) chaired the event, with Andrew Holden (Auckland, New Zealand) moderating the panel discussion.

This is a global issue that requires global collaborations.”

SABINE STEINER (LEIPZIG, GERMANY) told the CX 2020 LIVE audience that the COMPARE trial, the first head-to head comparison of two paclitaxel-coated drugcoated balloons (DCBs), showed “excellent efficacy” at one year in both arms. There was a similar patency at one year with the low-dose (2µg/mm2) Ranger DCB (Boston Scientific) compared with the higher dose (3.5µg/mm2) IN.PACT Admiral DCB (Medtronic).

While earlier meta-analyses have suggested an association between paclitaxel dose and late mortality risk, Steiner told the CX 2020 LIVE audience that the COMPARE trial results “cannot identify any signal for a relationship between paclitaxel dose and mortality, at one year or beyond”.

The COMPARE trial, published in the European Heart Journal, was a prospective, randomised, non-inferiority trial of high- versus low-dose paclitaxel DCBs for femoropopliteal interventions. All patients enrolled in the study had PAD categorised as Rutherford class 2–4.

The trial met both its primary efficacy (primary patency through 12 months) and primary safety (freedom from major adverse events through 12 months) endpoints.

Steiner says that the investigators, led by Dierk Scheinert (Leipzig, Germany), “will follow the patients up to five years by telephone calls in order to gain safety information”.

Focusing on all-cause mortality, Steiner noted that the COMPARE trial data show “an overlapping of KaplanMeier curves through four years”, indicating “no signal for any relevant difference [between the two different paclitaxel dosages] with respect to mortality”. She continued: “Actually, death rates are rather low. After two years, where we do have quite a good follow-up, we observe a death rate which is around 3%”.

When looking at individual causes of death, Steiner shared that the research team did not see any “clear signal of an excess rate of a specific cardiovascular or non-cardiovascular death subtype.

“Importantly,” she expanded, “the same holds true, or we see a similar pattern of causes of death, for the six patients who died in the high-dose DCB group.

Importantly, no death was considered procedure- or

device-related by the clinical events committee.”

Speaking as moderator of the session alongside chair Roger Greenhalgh (London, UK), Andrew Holden (Auckland, New Zealand) praised Steiner for bringing “new information that we are seeing for the first time” to CX 2020 LIVE. Prompted by a question from Greenhalgh, Steiner clarified that the COMPARE trial was never designed to compare mortality between the Ranger DCB and the IN.PACT Admiral DCB, but rather efficacy. “What I would really like to highlight,” she stressed, “is that we have these meta-analyses showing us a signal that even for efficacy there will be a difference with respect to dose, so a higher dose will be more efficient. This was really the background of the COMPARE trial, that we wanted to have a non-inferiority design with respect to efficacy and primary patency. Here, we did not see a difference, which is really in contrast to the results from the metaanalyses.”

Holden, who was one of the authors of a 2019 paper published in the Journal of Endovascular Therapy (JEVT) refuting the idea of there being a dose-dependent impact of paclitaxel devices, said he “entirely” agreed with Steiner’s conclusions, adding: “I think it [the dose model] is the weakest part of the original [2018, Katsanos et al] meta-analysis.” Addressing Steiner, he said, “You have really shown that a low-dose device is as efficacious [as a high-dose one].”

“High impact” of VIVA individual patient data analysis

US FDA assessing “totality of evidence”, calls out specific value of individual patient-level data sets

THE IPD ANALYSIS OF THE SAFETY OF paclitaxel-containing devices conducted by VIVA Physicians, based on the most complete available data set of mortality events from randomised controlled trials, identified an absolute 4.6% increased mortality risk—corresponding to a 38% increased relative mortality risk—associated with their use. This is a weaker mortality signal than that initially reported in December 2018 by Katsanos.

The analysis, based on the most complete available data set of mortality events from randomised controlled trials involving paclitaxel devices, included 2,185 patients (including those whose data were previously lost to follow-up) across eight studies, with a median follow-up of four years.

Presenting these results at CX 2020 LIVE, first published in Circulation, Gary Ansel (Columbus, USA) remarked: “The VIVA IPD has, and will continue to have, [a] high impact due to the richness of the dataset”.

Nearly two-thirds of the CX 2020 LIVE audience believe the VIVA Physicians’ IPD analysis does not provide consensus on the ongoing paclitaxel debate “once and for all”. When asked “Does the VIVA IPD settle this once and for all?”, 63% answered “no”.

Greenhalgh concluded: “What we have learnt today, from various pieces of data, is that this matter is not settled.

“What I personally like is that the FDA’s comments [see box to the right] have left room for doctors to decide what they consider to be the right thing to do for the patient.”

PROVIDING AN UPDATE ON THE PACLITAXEL late-mortality signal from the US Food and Drug Administration (FDA) perspective, Misti Malone (Centre for Devices and Radiological Health, US FDA) said that the agency is in the “signal discernment/refinement phase” of the ongoing investigation.

Following the FDA Advisory Committee Meeting last summer (19–20 June, Washington, DC, USA), approved paclitaxel devices have remained on the US market with labelling updates that discuss ongoing uncertainties regarding the signal, as well as the conclusions of June’s meeting. At the time, the agency agreed that the mortality signal existed, but that the signal magnitude was uncertain.

“Because patient comorbidities, extent of disease, and lesion characteristics play a role in clinical outcomes, [the] FDA believes it is important for physicians to determine what patients are considered [at] high risk of restenosis, and they have a favourable risk–benefit profile from treatment with paclitaxel-coated devices.”

Clinical trials are continuing with revised informed consent and increased patient follow-up. Additionally, the FDA has also promoted efforts to increase trial robustness, such as attempts to reduce “missingness”.

“We continue to collaborate with investigators of observational datasets, and through groups such as RAPID, a multi-stakeholder collaboration made of clinicians, industry members, and regulators aiming to improve the real-world evidence ecosystem, from data collection to analysis,” Malone explained. “These collaborations may provide insights into remaining questions, such as the precise magnitude of the signal,

the mechanism for late-term mortality, and the benefit– risk profile in real-world patient populations.”

Malone stressed the importance of collaboration, finishing by saying: “This is a global issue that requires global collaborations.”

Referencing an earlier presentation on what he described as “another large, population-based study that failed to show a [mortality disadvantage], but in fact showed a mortality advantage of paclitaxel”, moderator Holden said he has found large population-based studies “reassuring”, and asked for the FDA’s thoughts on these types of analyses.

“We value the totality of evidence,” Malone replied, “be it from randomised controlled trials, single-arm trials, or observational datasets. The devil is in the details for many of these trials, in which we identify how many patients have been followed-up to four or five years, which is when the signal was noticed in our datasets.

Many of these datasets have up to 50% missingness at this point, and although we may assume missingness accepts some level of randomness, it may not, so we typically need very robust, high-quality data with long follow-up in order to discern this mortality signal. So, we do value these observational datasets, and as part of the RAPID group, we are compiling all of the datasets we are aware of, and looking at the level of evidence and our confidence in the data that has been evaluated.”

Specifically commenting on individual, patient-level analyses, such as the VIVA individual patient-level data (IPD), Malone said: “We find those very valuable because we can dive into the details, we can see how the individual patients are affected.”

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PCR e-Course 2020

July 2020 | Issue 78

Treatment with transcatheter bariatric embolotherapy results in greater weight loss than sham procedure Transcatheter bariatric embolotherapy (TBE) for obesity is safe and leads to clinically significant weight loss in comparison to a sham procedure, a hotline and innovation session at PCR e-Course 2020 (25–27 June) were told. TBE also demonstrated a greater improvement in quality of life and hunger scores. Vivek Y Reddy (Homolka Hospital, Prague, Czech Republic, and Icahn School of Medicine at Mount Sinai, New York, USA) shared the findings from a pilot, single-blind, sham procedure randomised controlled trial.

REDDY TOLD THE online audience: “Bariatric surgery is a highly effective procedure, and improves cardiovascular outcomes as well as mortality, but this invasive surgical procedure has significant morbidity and mortality associated with it, and that limits its utility to those patients who are severely obese, with BMIs [body mass index] almost always over 40.

TBE is a novel catheter-based approach.

It involves embolisation of microspheres to the left gastric artery [LGA] to cause ischaemia to the gastric submucosa. A number of preclinical studies, as well as clinical case series, have indicated that bariatric embolotherapy promotes weight loss—thought to be due to a mechanism of reducing ghrelin, which is the only known appetite-stimulating hormone in the body, and is secreted largely from the Vivek Reddy gastric fundus.”

The current study compared TBE to a sham procedure in a first-in-human trial conducted at two centres in Prague, Czech Republic (PIs: Petr Neuzil and Martin Fried). The first was a bariatric surgery centre that conducted most aspects of the trial, including patient enrolment, consent, weight counselling, and all of the follow-up. The second centre performed the randomisation and treated patients, either with embolotherapy or the sham procedure.

Key inclusion criteria were a BMI of between 35 and 50, and age 21–60 years. Patients were excluded if they

had had prior bariatric surgery, had a history of ulcers, had type 2 diabetes, an active H. Pylori infection, or if they were chronic users of aspirin or non-steroidal antiinflammatory drugs (NSAIDs).

Randomisation of consenting patients was 1:1 to TBE or a sham procedure. In TBE, femoral arterial access was obtained and a coeliac angiogram using a 6Fr guide was performed. Using an occlusion balloon microcatheter, beads which ranged between 300µm and 500µm were injected into the LGA to achieve stasis. Injection was performed using a custom robotic manifold designed to inject the beads at the correct pressure. The Sham procedure involved the infiltration of lidocaine into the skin in the femoral area, and propofol was infused for one hour.

The primary efficacy endpoint was total body weight loss compared between TBE and sham therapy. Age, weight, and BMI were similar across the two groups. Patients were analysed in both intention-to-treat (ITT) and per protocol (PP) populations. After six months’ follow-up, crossover was permitted. TBE patients were followed for one year and sham patients for six months. After exclusions and withdrawals, 40 patients were randomised, 20 to each group. Following treatment, analysis of efficacy and safety was performed on 19 patients in the ITT population in the TBE group and on 18 patients in the

Sham patients from RADIANCE-HTN SOLO who crossed to denervation had blood pressure reductions Patients who crossed over from the sham control arm of the RADIANCE-HTN SOLO trial to the renal denervation arm after 12 months of elevated blood pressure had decreased daytime ambulatory systolic blood pressure at both two and six months following renal denervation. The analysis of the crossover cohort was presented by Ajay J Kirtane (Columbia University Medical Center/New York-Presbyterian Hospital, New York, USA) during a late-breaking trial session at the PCR e-Course 2020 (25–27 June).

R

ADIANCE-HTN SOLO was a multicentre randomised controlled trial that demonstrated the blood pressure lowering effect of endovascular ultrasound-based renal denervation (Paradise, ReCor Medical) compared with a sham control. Patients randomised to sham treatment who had daytime systolic ambulatory blood pressure ≥135mmHg or daytime diastolic ambulatory blood

pressure ≥85mmHg after 12 months of follow-up were permitted to crossover to receive endovascular ultrasound-based renal denervation.

Kirtane said: “This analysis represents data on the cohort of 31 patients that had crossed-over as of January 2020.

Complete two-month ambulatory blood pressure data are available on 31 participants, with complete six-month

sham group. The PP analysis of efficacy was performed in 15 patients treated with TBE and 16 with sham procedure.

Mean procedure time for TBE was 82.3 minutes. In 16 patients one vessel was injected, two were injected in two patients, and three in the remaining patient of the original 20 randomised to the procedure (19 treated with TBE).

Reddy announced the outcomes: “On the safety side, there was only mild nausea or vomiting that was selflimited, and minor ulcerations in five patients. All of these ulcers were asymptomatic and were self-limiting, requiring no additional treatment.”

At six months, the primary endpoint of weight loss for the ITT population was 7.4kg in the embolotherapy group versus 3kg in the control group (p=0.034). In the PP population, it was 9.4kg in the TBE cohort compared with 1.9kg for the sham therapy (p=0.0002).

A comparison of TBE from baseline to 12 months found a 7.8kg loss in the ITT population (p=0.0011), and a 9.3kg loss in the PP population (p=0.0005). In addition, at both six and 12 months from baseline, TBE treatment led to a greater improvement in quality of life measures than sham treatment for physical function, self-esteem, sexual life, public distress, and work, as well as overall quality of life. Hunger scores also decreased to a greater extent for TBE than sham treatment at both six and 12 months from baseline.

Reddy concluded: “In this randomised pilot trial we established the proof of principle that transcatheter bariatric embolotherapy of the left gastric artery is safe, and it promotes clinically significant weight loss. There was an improvement in the hunger scores, significant weight loss that was maintained out to one year, and this also translated to improvements in quality of life.”

Reddy told Interventional News: “We believe this is an important trial that convincingly demonstrates for the first time that TBE helps promote weight loss. However, there is much additional work that remains to be done— most importantly a large multicentre trial to assess efficacy in the hands of a large number of operators, rare safety events that can only be identified after treating a large number of patients, and corroborating data on hormones (for example, ghrelin). My understanding is that the company that sponsored this pilot study is planning to conduct a large US pivotal FDA trial using a second generation TBE system (micro-infusion catheter and robotic manifold).

data available on 25 patients.”

Average age in the crossover population was 54 years. Average daytime ambulatory blood pressure was 145/90mmHg, with a 24-hour ABP of 138/85mmHg, and office blood pressure of 146/95mmHg. The average number of hypertensive medications at crossover was 1.2±0.7. Mean time from randomisation to crossover was 23±5 months.

There was 100% procedural success with renal denervation and there were no deaths from any cause.

Kirtane said: “This cohort demonstrated a daytime ambulatory systolic blood pressure change of -11.2mmHg at two months and -12.2mmHg at six months [p<0.001 in comparison to 12-month baseline for both], without an increase in medication burden; through six months, there were no major adverse events following crossover.”

At two months, 71% of patients had a decrease of ≥5mmHg in daytime ambulatory systolic blood pressure; at six months, this was 68%. Among these patients with a response 5mmHg

in daytime ambulatory systolic blood pressure, at two and six months, the average daily ambulatory systolic blood pressure reduction was 17.7 and 20.6mmHg, respectively.

Kirtane summarised: “Control of hypertension represents an unmet need globally, and renal denervation is an ‘adherence-independent’ adjunctive therapy to medications. These results are consistent with the primary SOLO results; however, there was no drug titration protocol between two to six months for crossover patients, so this may provide some added insight into sixmonth durability after renal denervation.”

He additionally stressed that, because crossover subjects and physicians were unblinded, the data are subject to behavioural and/or medication-related effects, and as such need to be interpreted within the context of the blinded study results. Nonetheless, “these data are further supportive of an adjunctive role of ultrasound-based renal denervation in the treatment of hypertension, especially when considering how many patients with hypertension worldwide are currently uncontrolled”, Kirtane said.

Inclusion in IR

Issue 78 | July 2020

“We believe in diversity and inclusion”: SIR issues statement of commitment in support of diversity The Society of Interventional Radiology (SIR) president Michael D Dake (University of Arizona Health Sciences, Tucson, USA) and diversity and inclusiveness group chair Paul J Rochon (University of Colorado Hospital, Aurora, USA), have issued the following statement on supporting diversity and combating racial inequality in the USA.

“H

umanity has been dealt many challenges this year. While COVID-19 has undoubtedly received much of our attention, we suffer from another pandemic that remains a structural and pernicious threat—racism. The Society of Interventional Radiology (SIR) will not be silent on this issue.

“We denounce any act of hatred and bigotry on the basis of race, ethnicity, religion, sexual orientation, or gender identity. We denounce the long history of hatred and violence against the Black community and support our Black patients, physicians, trainees, nurses, technologists, industry partners, staff and administrators. We need to stand together in strength and work with a common purpose to realise a more diverse, equitable and inclusive organisation.

“We commit to antiracist efforts, policies, and programmes that aim to increase the numbers of underrepresented minorities and women within our specialty. Our GEMS programme supports diversity in interventional radiology by providing a travel grant for medical students from diverse backgrounds who desire to participate in a visiting clerkship in interventional radiology (IR) outside of their home institution.

“We value a culture of inclusion in which all members of the IR community are accepted, respected, and embraced.

The society’s IAmIR campaign has both celebrated and drawn attention to diversity within the specialty.

SIR has microgrants that support research performed by female and underrepresented minority scientists and a speakers’ bureau to ensure interventional radiologists of colour are tapped as experts in their field at scientific meetings.

“We strongly support the need to reduce and eliminate health disparities that affect our Black patients and other patients of colour. SIR’s Diversity and Inclusiveness Group Task Force has been working for several years to ensure that these issues are a vital part of our strategic plan.

“We call upon our membership and affiliates to take this time to remember the families and communities of George Floyd, Breonna Taylor, Ahmaud Arbery and many others who have been subject to unconscionable acts of discrimination and hate. We ask that everyone look into his or her heart to understand the overdue need for change in the nation. With our

intentional efforts, SIR calls to action the continuing need to develop strategies to ensure justice, diversity, equity and inclusion.”

Interventional radiologists were among the hundreds of healthcare workers who participated in White Coats for Black Lives events across the USA

During the events on 5 June, residents, physicians, fellows, and other healthcare workers knelt for eight minutes and 46 seconds, the length of time that a Minneapolis police officer knelt on the neck of George Floyd. Other healthcare workers stood and marched in solidarity.

Healthcare workers used the protest as a time to condemn racism and remember Floyd, Breonna Taylor, and other black lives lost.

Interventional radiologists who participated in the event hailed from departments across the country, including the University of Virginia School of Medicine, Northwestern Medicine, University of Texas (UT) Southwestern Medical Center, Oregon Health and Science University, and Washington University of St Louis. In addition, the radiology department from the University of Alabama at Birmingham noted it held a moment of silence at the beginning of a virtual celebration for graduates.

The Radiological Society of North America (RSNA) also released a statement, writing on Twitter: “RSNA stands in support of the African-American community. With a mission to promote the health and well-being of all people, the senseless loss of life we continue to witness is extremely disturbing and heartbreaking. The unjust treatment of people of colour must stop.”

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Critical limb-threatening ischaemia

Issue 78 | July 2020

Figure 1

Figure 2

Figure 3

Figure 4

Critical limb-threatening ischaemia interventions buck trend for emergency only procedures A BIBA MedTech Insights survey (conducted May 2020) indicates a trend towards centres only performing emergency percutaneous peripheral procedures during the COVID-19 pandemic. However, this trend is not seen with stenting/angioplasty for critical limbthreatening ischaemia (CLTI). With CLTI, the trend is for at least some elective procedures to still be performed.

BIBA MEDTECH INSIGHTS polled physicians at 238 centres across the globe about how the pandemic has affected clinical practice at their centre. More than half (55.8%) of respondents were vascular surgeons, with the rest of the respondents ranging from interventional radiologists to angiololgists.

Furthermore, 46% of respondents came from four of the largest European countries: Italy, Germany, the UK, and Spain. This article reviews the key Western European findings from the survey.

The survey showed that, in

Western Europe, for both peripheral embolization and stenting/angioplasty for claudication, the majority of centres were only performing emergency procedures. For example, 69% of respondents reported that they were only performing emergency peripheral embolization and 61% said that they were only performing emergency stenting/angioplasty procedures for claudication. However, this tendency was not seen with critical limb ischaemia procedures.

For stenting/angioplasty procedures for critical limb ischaemia, the majority of centres were performing at least some elective procedures:

40% for some procedures and 19% for all procedures versus 41% only performing emergency procedures (Figure 1).

Furthermore, of those still performing elective procedures for critical limb ischaemia, the tendency was for them to report seeing a reduction of 50% or less in elective procedures rather than a reduction of more than 50% (Figure 2).

The split between emergency only versus some versus all elective percutaneous procedures, for CLTI, did vary depending on the country.

For most countries, the majority of centres were still performing at least some elective procedures.

However, in the UK, 52% of centres reported performing only emergency procedures. In Spain, by contrast, only 29% of centres report performing emergency procedures (with 42% performing all procedures; Figure 3).

Given that the survey suggests

13

that elective CLTI procedures have continued (albeit at a reduced level) during COVID-19, one may expect centres to “return to normal” relatively quickly once COVID-related restrictions have been lifted. Indeed, the survey does find that the majority of respondents in Western Europe estimate that their centre will go back to performing their usual level of elective critical limb ischaemia procedures within three months.

Interestingly, although there is some variation, this trend is seen for all countries, including the UK. In terms of the measures needed to “clear the backlog” of elective procedures, overall, increased operating days, adjusted working practices (such as more frequently using a minimally invasive approach), and increased operating hours were the most common answers. However, of note, 10% felt no extra measures would be necessary.

BIBA Briefings BIBA Briefings is an online platform (www.bibamedtech.com/bibabriefings) that gives an in-depth analysis of the latest market intelligence from BIBA MedTech Insights (www.bibamedtech.com). It also reviews the latest industry news and pipeline developments.

For sales enquiries (including BIBA MedTech Insights), please contact Merveille Anderson: merveille@bibamedical.com

IR in Tanzania

Issue 78 | July 2020

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RSNA grant enables establishment of an IR service in Tanzania “There is a general misconception that you cannot do interventional radiology (IR) in a resource limited setting,” says Fabian Laage Gaupp, IR resident at Yale School of Medicine (New Haven, USA), and a member of the Yale Radiology Outreach Program. He is outlining his work alongside colleagues to establish a radiology service at the Muhimbili National Hospital campus in Dar es Salaam, Tanzania. “From having done this for almost three years, I can say that this is simply not true,” he says, picking up on the earlier statement.

T

he initiative has seen more than 50 volunteers travel to Tanzania in teams of up to five for twoweek placements to provide hands-on training to radiology residents, nurses and technologists. Funded initially through donations and institutional grants, the project has recently been awarded funding through the Radiological Society of North America (RSNA) Derek Harwood-Nash International Education Scholar Grant scheme, which Laage Gaupp says will help to continue the initiative into the immediate future.

The project has grown out of work begun by Yale’s director of neuroradiology MRI and assistant professor of neuroradiology, Frank Minja, who initially sought to implement a Picture Archiving and Communication System (PACS) at the Muhimbili Orthopaedic Institute in Dar Es Salaam in 2014. Since then, Minja has made regular trips to Tanzania—the country of his birth—to support physician training in the country. Minja crossed paths with Laage Gaupp, who joined Yale as a radiology resident in 2016, and, hungry for outreach opportunities within the IR field himself, joined Minja on a trip to Dar es Salaam in 2017.

“In Africa you have around 1.3 billion people currently, and there are really only two countries where IR is established—South Africa and Egypt,” says Laage Gaupp, discussing the demand for IR services across the continent. Tanzania has a population of over 50 million, including over four million in Dar es Salaam, the country’s most populous city and the focal point of the outreach programme. During his first trip to the country, Laage Gaupp armed himself with an Interventional Radiology Readiness Assessment tool to establish the scope for setting up an IR service within the country. In terms of the availability of imaging equipment to support IR work, he found that this could be feasible, but the disposable equipment needed was lacking. Undeterred, he set about designing a training scheme that could bring IR into the country.

“We have followed the same training model that we do in the USA, doing three years of diagnostic radiology, followed by two years of an IR residency. In Tanzania they already have the three years of diagnostic radiology residency, so we essentially just have to add two years of interventional radiology.”

To date, six residents have enrolled over two year groups, with the first group of three residents set to graduate in September 2021. They are undertaking a combination of on-the-job training and lectures delivered by the visiting groups from institutions across the USA and Europe. Visiting groups, who visit for two weeks at a time, comprise at least one physician, nurse, and technologist, reflecting the fact that IR is, in Laage Gaupp’s words, “a team sport”. Groups may also be augmented by medical students and radiology residents. The ultimate aim of the programme is the establishment of a self-sustaining IR residency programme at Muhimbili, with Tanzanian IR faculty training Tanzanian residents. “Our focus has always been on getting them [Tanzanian trainees] to be able to work independently quickly and we are already starting to see the outcomes of that,” Laage Gaupp comments. “They are already doing a lot of procedures independently, so now on a daily basis they do CT and ultrasound guided core needle biopsies, they do nephrostomy placements, and they do biliary drain placements, which is really considered a technically challenging

Even with those really basic procedures, you are going from a patient dying to that patient surviving.” procedure in many cases. There is no trained IR attending in Tanzania, but they are able to provide these really life-saving procedures, and have great success.”

The course has been designed to begin with teaching residents more basic procedures: “those that are more necessary”, Laage Gaupp says, such as core needle biopsies. “That might not be considered a life-saving procedure, but it is extremely necessary, because until then people were only doing fine needle aspiration, which has a much lower diagnostic yield.

“We felt that is something that would have a really significant impact on patient care because it is going to

Tanzanian trainees and technologists learning with interventional radiologists from Yale and Emory Universities, USA.

help you diagnose and help to guide the treatment. At the same time, it is a simple procedure where you can learn [to use] image guidance and you have a lower chance for complications.” Other procedures, including abscess drainage and nephrostomy and biliary drainage, have been prioritised, due to the potential impact these could have on morbidity and mortality compared to surgery. “Just by making those procedures available, that is the highest return in terms of patient outcomes that you can have. Even with those really basic procedures, you are going from a patient dying, to that patient surviving,” he emphasises.

Discussing some of the differences in running an IR service in East Africa, compared to the USA, Laage Gaupp comments that there is a significant difference in the “disease spectrum” of patients using healthcare services in Tanzania, with a high prevalence of parasitic infections, for example, as well as in the stage at which patients present in-hospital for treatment. “People present a lot later in general [in Tanzania],” Laage Gaupp remarks. “In the USA in particular, when people have the slightest headache or stomach ache, they usually go and see a doctor. In Tanzania, the coverage is different. For someone from a rural area to actually present to the national hospital in Dar es Salam takes months or sometimes years. Until they get to the national hospital, those are really the sickest of the sick, people show up with huge tumours, with roaring infections, with anything under the sun.”

Another aspect he notes as being specific to Africa is a higher percentage of paediatric patients. “While paediatric interventional radiology in the USA is

considered a bit of a fringe subset of IR, in Sub-Saharan Africa, paediatric interventional radiology will play a pretty big role because there are so many paediatric patients,” he notes.

He also points to a large prevalence of uterine fibroids, which is particularly prevalent in black women compared to in predominantly white or Asian populations, adding that the introduction of uterine fibroid embolization (UFE) has the potential to have a huge benefit throughout the region.

“If you look at UFE in particular, and you compare it with hysterectomy, one of the most common procedures worldwide, complication rates in Sub-Saharan Africa are on average higher than in Europe or the USA,” Laage Gaupp comments.

“Now with UFE, the procedural risk is much lower, and second of all you do not need general anaesthesia, so you are taking that risk out. It is such a common problem, even if you said IR was limited only to UFE, that alone would justify bringing IR to sub Saharan Africa.”

The outbreak of COVID-19 has meant that outreach trips have been cancelled until it is safe to travel again. Laage Gaupp hopes that this will be before the end of 2020, but faculty have been able to offer online education through video conferencing. “If there is a positive thing that has come from COVID-19, it is the access to online teaching,” he comments, but notes that there is “no substitute” for hands-on teaching, particularly within IR.

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Interview

July 2020 | Issue 78

Profile

Bill Rilling

Instrumental to the development of interventional oncology in the USA and globally, William (Bill) Rilling tracks how the discipline has grown over the course of his career from a niche area of medicine for the most challenging cases to a subspecialty with its own society dedicated to revolutionising cancer care.

What initially drew you to interventional radiology (IR), and then specifically to cancer care?

My father was an engineer at GE Medical working on MR imaging systems and I had a summer job at GE working on MR spectroscopy experiments, so I was exposed to the power of rapidly progressing diagnostic imaging at an early age. In medical school, however, I was drawn to the operating room. I was torn between diagnostic radiology and surgical subspecialty training such as urology, but then I watched John McDermott drain a paraspinal abscess under CT guidance and the decision was made. The decision to focus on cancer interventions was more pragmatic: as a junior faculty member at the Medical College of Wisconsin, we were developing a strong multidisciplinary vascular practice but the turf battles with vascular surgery and cardiology were exploding at academic medical centres nationwide.

Cancer interventions were a blue ocean, with huge potential. I was also drawn to the cancer patient population—to see people face terrible circumstances with courage and grace is truly inspirational.

Who have been important mentors for you throughout your career?

During my fellowship at Northwestern University, both Bob Vogelzang and Al Nemcek influenced me greatly. At that time, Bob was spending many hours per week in meetings helping the Society of Interventional Radiology (SIR) construct the component coding system. Al was also doing work in multiple SIR committees and was starting to build some early quality infrastructure in IR. They both taught me that it was not enough to do the work of patient care every day, but that we should be giving back to this wonderful specialty by volunteering our time and expertise to help IR continue to grow. In my clinical practice, it was my honour to work for 10 years with Jonathan Towne, who was a national leader in vascular surgery, a superb surgeon, and a fantastic and caring physician.

What challenges did you face in the early years of your interventional oncology (IO) practice?

Initially, the challenges were to introduce the concept of IO techniques to colleagues in medical and surgical oncology. As with much of IR, we started out by treating patients with little hope that had no other options. Once introduced, the power of these interventions were self evident—to see a patient walk out the door the same day after ablation of liver cancer, now cancer free. The integration of transarterial chemoembolization (TACE), radioembolization, and percutaneous ablation into practice patterns then followed, and so did the higher levels of evidence supporting their use. Currently, the challenges are different. The rapid development of new targeted cancer drugs, and in particular immunotherapy, is revolutionising cancer care.

You were involved in running the first ever meetings dedicated to IO back in 2001. How did this come about?

I joined the education committee for SIR as a junior faculty member to start getting involved in SIR. In

the early 2000s, the role of IR/IO in management of hepatocellular carcinoma (HCC) was beginning to blossom. At this time, I met Jeff Geschwind, and we planned and executed the first three standalone meetings focusing on multidisciplinary HCC management, beginning in 2001. To my knowledge, these were the first dedicated IO meetings ever organised, but of course, the term “interventional oncology” did not exist at that time.

As education counsellor on the Executive Council for the SIR, you helped develop the APDIR. How did this improve IR education?

At that time, the IR programme directors met only once per year, for a couple of hours at the SIR annual meeting. The issues being faced by training programmes were becoming more complex, such as turf battles with other specialties, and it was clear we needed a more organised structure. With the support of SIR, we formed the Association of Program Directors in Interventional Radiology (APDIR). The APDIR had a standalone meeting once per year with staff support from SIR. We started to tackle some urgent issues such as consistent participation in the match process and the development of a core IR curriculum. Through APDIR,

We need to embrace subspecialisation and not fear it.” the programme directors were able to coordinate efforts and best practices to deal with the erosion of vascular cases, attracting medical students and residents to IR, and improving non-procedural patient care skills.

You were instrumental to the implementation of the IR residency task force. How did this come about?

In the early to mid 2000s, it was clear that IR was evolving into a specialty caring for a complex array of patient populations and that direct patient care was necessary to foster the growth of these new areas of practice. Delegation of the patient care aspects and just “doing procedures” was not an option. The complexity and diversity of interventions performed was expanding rapidly and the one-year fellowship training pathway was not sufficient to adequately prepare IR trainees for future practice. We formed the Primary Certificate Task Force in 2006, chaired by John Kaufman, with an initial goal of obtaining a standalone IR certificate. It soon became clear that Diagnostic Radiology chairs and the American Board of Radiology and American College of Radiology would not support a pure IR certificate but would support a combined IR/DR certificate. The ensuing process of navigating the politics, obtaining ABMS and ACGME approval, and implementation into the match was exceedingly complex and took over a decade from start to finish. The IR/DR certificate was the first new primary specialty approved by ABMS in over two decades. Now, medical students can match directly

into a six-year IR/DR programme that will prepare them for modern IR practice. By some measures, it is the most competitive specialty in American medicine.

How would you describe the decision to create the Society of Interventional Oncology (SIO) in 2017, and the reaction of the IR community?

The decision to form SIO was made after a very long and thoughtful dialogue that occurred over a few years. The World Conference of Interventional Oncology (WCIO) had been in existence since 2005. WCIO was evolving into much broader activities, including research grants, clinical trial development, and advocacy with various cancer organisations. It was becoming much more than a meeting or conference. We also realised that there would be political ramifications to forming a new society. The last thing we wanted to do was damage or undermine IR as a whole, but felt that a small society focused on IO would have a positive impact on the future of patient care and, ultimately, IO as a subspecialty. The reactions to forming SIO were varied. Certainly, there were some who feared this would weaken IR and might set a precedent for other subspecialties to “break off”.

Interview

Issue 78 | July 2020

17

Fact File

Current positions

2006–Present: Professor, Department of Radiology, Vascular & Interventional Radiology, Medical College of Wisconsin, Milwaukee, USA 2006–Present: Professor, Department of Surgery, Surgical Oncology, Medical College of Wisconsin, Milwaukee, USA 2006–Present: Vice Chair, Clinical Operations, Department of Radiology, Medical College of Wisconsin, Milwaukee, USA

Society positions

2019–Present: President, Society of Interventional Oncology 2014–Present: Member, Board of Directors, Society of Interventional Oncology 2016–Present: Service Line Representation, SIR Service Line Advisory Board, Society of Interventional Radiology 2006–2008: Education Counselor, Society of Interventional Radiology (SIR) Executive Committee 2005–2008: Board of Directors, SIR Foundation In my view, the development of subspecialty groups and societies is part of the natural evolution of IR. This process has occurred in many other medical specialties over time and is predictable. IR practice development is significantly driven by those who focus on subspecialty areas of practice, such as prostate artery embolization (PAE), venous disease, or women’s health. We need to enable subspecialisation and not fear it.

What has been the highlight of your presidency of the SIO?

For me personally, the highlight is to see forward progress on multiple fronts. We have organised expert panels to provide regular comments to disease-specific National Comprehensive Cancer Network guidelines with some early evidence that we have initiated positive changes. We have organised committees working with existing cooperative groups such as ECOG/ACRIN to develop IO trials. Working with industry partners, SIO has awarded US$1.5 million in translational research grants, some of which have led to larger national grants.

We are working with SIR to build IO-CORE, a large and disease-specific registry platform for IO. We also have multiple clinical trials in development.

What are the main considerations when treating patients with cancer during a pandemic?

It is a very challenging situation given that cancer patients are vulnerable and have poor outcomes when infected with COVID-19. However, we also know that their cancer needs treatment and that delaying treatment could result in poorer outcomes. So we must balance the risk and benefit; in the majority of cases, we have proceeded with IO treatments as usual. The exceptions have been renal cell cancer ablations and a low number of very small liver tumours that have demonstrated relative stability on imaging. We have worked diligently, as I am certain all IR practices have, to separate inpatient and outpatient flows to minimise risk for patients coming in for outpatient treatment.

What are your hobbies outside of medicine?

I have a wonderful family, including my wife Kate and my three children, Nicholas, Gabrielle, and Nathaniel.

I love spending time with them and doing anything outdoors: hiking, skiing, fly fishing, boating, running, and still manage to get up and down the basketball court.

Education

1995–1996: Fellowship, Vascular & Interventional Radiology, Northwestern Memorial Hospital, Chicago, USA 1991–1996: Resident, Diagnostic Radiology, Medical College of Wisconsin and Affiliated Hospitals, Milwaukee, USA 1990–1991: Transitional Internship, Virginia Mason Hospital, Seattle, USA 1986–1990: MD, University of WisconsinMadison School of Medicine, Madison, USA 1982–1986: BS, Biochemistry, University of Wisconsin-Madison, Madison, USA

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PERIPHERAL

CIRSE and COVID-19

Issue 78 | July 2020

Interview

CIRSE president: “We need more of a European focus” to protect against viral outbreaks “Europe, including the European Union (EU) and the leaders of its nation states, needs to prepare better for future pandemics. I think we must develop a Europe-wide contingency plan providing clear guidance on effective measures,” says Afshin Gangi, president of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE). Speaking with this newspaper, he outlines the society’s response to the coronavirus pandemic, as well as measures taken by his own institution.

What is CIRSE doing currently to support its membership amidst the coronavirus pandemic?

The health of our members, congress goers, and industry partners has always been our top priority. This is why CIRSE reacted quickly following the outbreak of COVID-19 in Europe, moving our spring meetings to later dates in the year. The European Conference on Interventional Oncology (ECIO) 2020, which was planned for 26–29 April, has been moved to 2–5 November, in Nice, France. The European Conference on Embolotherapy (ET) and the International Conference on Complications in Interventional Radiology (ICCIR) were both going to take place in Austria in June, but since the restrictions on travel and gatherings will still be in place then, they have also been postponed. ET 2020 will take place 16–19 December in Vienna, Austria, with ICCIR 2020 Afshin Gangi running in parallel at the same congress centre from 16–18 December. The courses of the European School of Interventional Radiology (ESIR) are also being moved to autumn and spring 2021, hopefully once again enabling participants from around the world to join us for the comprehensive two-day courses on specific procedures. The CIRSE annual congress will also take place virtually, from 12–15 September.

In addition to these event-related activities, and in order to ensure that the exchange of experiences and medical education does not stop, we have put into action a series of measures to support online information exchange between interventional radiology (IR) professionals. Within a very short timeframe, a CIRSE/Asia Pacific Society of Cardiovascular and Interventional Radiology (APSCVIR) working group put together a joint CIRSE-APSCVIR checklist to prepare IR departments for COVID-19. My special thanks go to main authors Bien Soo Tan and Kiang-Hiong Tay, both from Singapore General Hospital, Singapore, for sharing the knowledge they gained from both the SARS and the COVID-19 pandemics (see page 21).

As the coronavirus continues to spread, it is key to be prepared to carry out emergency procedures in this new environment and treat possibly infected patients. Our knowledge is increasing by the day, which is why CIRSE has also offered a series of freely available webinars, where front-line doctors shared their experience. In the first of these webinars, two Italian interventional radiologists talked about bedside procedures IR provides to COVID-19 patients.

In addition, seven fully CME accredited CIRSE Academy courses have been made freely available, as have almost 200 lectures from previous CIRSE congresses via the CIRSE Library. We are confident that by taking these steps, we will be able to continue providing excellent IR education and supporting information exchange by an increased internet offering for the time being, and again in person once the pandemic has subsided.

CIRSE had to pull together a comprehensive resource centre rapidly.

How did this come about? What needed to be prioritised, and how did you identify key stakeholders to work with?

In an effort to offer a concise and useful information hub amidst the myriad of online content on the pandemic, the CIRSE publications department has put together a collection of the most relevant links.

These include the main stakeholders on an international scale, such as the World Health Organisation and the European Centre for Disease Prevention and Control, as well as articles, webinars, and checklists of particular relevance to interventional radiologists. Many thanks go to the CIRSE team. They really did an excellent job in putting all this together in such a short period of time.

In general, I think the internet is one of the big advantages we have during this pandemic and compared to past outbreaks.

Even in comparison to SARS in 2002/2003, today it is so much easier for medical professionals to quickly share information and their experiences with colleagues from around the globe.

We must develop a Europe-wide contingency plan providing clear guidance on effective measures.”

Is there a COVID-19 learning you wish to share with the interventional community?

I can only report on my own experiences in Strasbourg.

The first major impact of the COVID-19 crisis was the cancellation of many elective interventions.

Unfortunately, among the procedures that were classified as “not urgent” were many oncologic interventions, as well as benign pain management interventions. The delay in receiving their scheduled therapies is very stressful for patients and it will be important to start the interventional service again as soon as possible. I really admire how patients have reacted when learning that their therapies have been postponed. At the moment there is a lot of understanding and strong support for the medical community. However, it is not good to put them off from week to week and I hope that this situation will not persist for too long.

I think another important learning was that we are able, in a very short period of time, to change our workflows and patient pathways. Levels of safety and hygiene needed careful scrutiny and refinement to protect non-infected patients and hospital staff. Sadly, even with our immediate measures, it was impossible

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to avoid that some colleagues got infected and to my deepest regret a few colleagues even lost their lives.

I want to say that the medical and paramedical staff have been remarkable in this crisis, and I have the feeling that we are now even more united than before. In Strasbourg it seems that the peak has been reached and the situation is slowly starting to ease. However, we all know that this pandemic is far from over. We need to be careful not to provoke a second wave until medication, and hopefully a vaccination, against COVID-19 has been developed. Until that time, we will have to get used to our ‘new normal’.

Another important learning is that we need more of a European focus, not less. Europe, including the European Union (EU) and the leaders of its nation states, needs to prepare better for future pandemics. I think we must develop a Europe-wide contingency plan providing clear guidance on effective measures. Maybe there were good intentions from the EU leadership to introduce such a system after SARS in 2002/2003, but it seems that far too little was put into action.

Among the many things that need improvement, I think, is that Europe should rebuild its infrastructure critical to the production of pharmaceuticals and medical equipment. This is essential, and would allow us to be independent and more proactive in the future.

What procedures are interventional radiologists still undertaking in this period?

In my experience, apart from the conventional emergencies such as bleeding, thrombectomies, or abscess drainages, we have of course also noticed more complications in the intensive care units related to COVID-19 patients with epistaxis or vascular damages.

In Strasbourg we also have seen an increase in thrombosis, but not necessarily in thrombectomy cases.

How has your personal daily practice been impacted by the pandemic?

What measures has your hospital implemented?

Our department in Strasbourg has six operating rooms; three of them have been put out of function, with the removal of all anaesthesiologic devices and tools. We are fortunately still able to work in two angiography suites and one CT-angiography suite.

Unfortunately, we have reduced collaboration with our colleagues from anaesthesiology. Outside of emergencies we currently receive their support only once a week. Additionally, all of our nurses have been assigned to other departments dealing with COVID-19 patients. Also, our medical staff has been temporarily reduced.

We are now preparing for the comeback and will be ready to catch up on the many postponed interventions once a regular IR service will again be possible.

What message would you like to give to the wider medical community at this time?

I think that the exchange of information is crucial. This is the first time that we have been confronted with a pandemic of this scale. We are gathering experience and seeing what works in real time, while at the same time having little to no data available on how exactly the virus works, and how it affects the body. We must therefore share all newly gained knowledge as quickly as possible.

Each of us adding a piece of the puzzle on how to respond to and defeat this dreadful disease. It is a great challenge, but I am confident that we will get through this together, emerging stronger as physicians and a community.

Afshin Gangi is an interventional radiologist at the University Hospital of Strasbourg, Strasbourg, France, and is the president of the Cardiovascular and Interventional Radiological Society of Europe.

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A world-class COVID-19 response

Issue 78 | July 2020

21

Six-step plan at the heart of Singapore General Hospital’s COVID-19 response The COVID-19 pandemic will have a deep impact on the future of healthcare, according to Tan Bien Soo, Singapore General Hospital (Singapore). He tells Interventional News how his institution has prepared for and dealt with the pandemic, including a six-step programme for preventing the spread of the SARS-Cov-2 virus, how this response was influenced by Singapore’s experience tackling SARS, and how the pandemic will shape healthcare services into the future.

IR equipment wrapped in plastic sheeting to aid cleaning and to prevent COVID-19 transmission

Singapore General Hospital (SGH) was well-equipped to deal with the COVID-19 outbreak due to previous experience with SARS. Could you detail the similarities and differences between COVID-19 and earlier viral epidemics?

SARS was also a coronavirus spread by droplets, as is the SARS-Cov-2 virus which is the cause of COVID-19. Based on this, we can conclude that the SARSCov-2 virus also spreads by droplets.

However, beyond this, as it is a novel coronavirus, there is much that we still do not know about. We are now, for example, finding out that patients who are infected can have a presymptomatic phase when they can be very infectious.

This is unlike SARS. After our experience with SARS, infection control and prevention has become an integral focus for all staff in Singapore General Hospital and we are constantly training and auditing ourselves to prepare for the next big disease outbreak. We have also, over the years, designed our infrastructure to allow for segregation of patients with different infection risks.

Thus, in Singapore General Hospital, we have different interventional radiology facilities for inpatients and outpatients.

What are the most important steps for interventional radiologists to take when ensuring their departments are ready for COVID-19 patients?

This has been summarised in six

steps that we shared in the peerreviewed journal Cardiovascular and Interventional Radiology. The six steps are: Screen and segregate patients with different infection risks Segregate staff to prevent health care worker infection Prioritise requests to allow for reduction of workload and focus on ramping up infection control measures Minimise movement of isolated patients Review and enhance the workflows for infected patients Adhere strictly to individual infection prevention and control guidelines [The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) and the Asia Pacific Society of Cardiovascular and Interventional Radiology (APSCVIR) also published a checklist to use when preparing an IR department for COVID-19 patients.]

Elective procedures have been postponed or cancelled to mitigate the chances of coronavirus overwhelming the healthcare service. What counts as an elective procedure for an interventional radiologist, and what procedures are essential?

At Singapore General Hospital, we prioritise all clinically urgent and all inpatient procedures so that hospital length of stay can be shortened. For outpatient elective procedures, priority is given to patients with cancer who

We now have to start thinking about the ‘new clinical practice norm’ in the post COVID-19 era.” need treatment. Non-cancer related procedures that can be safely deferred (such as fibroid embolization, fallopian tube recanalisation, and arteriovenous malformation embolization) have been postponed.

Interventional radiologists have raised concerns over disposable sterile supplies.

What actions did SGH take to conserve supplies, and was there pressure from regulators to use them?

We quickly reviewed our existing guidelines for personal protective equipment (PPE) to ensure alignment with our institutional practice, and commenced refresher training in infection control. We stressed the need for appropriate use of PPE, and discouraged wastage. We also tracked our PPE stocks daily. That way, we have been able to maintain adequate supply.

On reflection, how do you feel Singapore has handled the COVID-19 outbreak?

What lessons can other countries learn from the response in your country?

What will the next few months look like?

In my opinion, we have handled the pandemic well. Even though we are now seeing a surge in case numbers, our hospitals are not overwhelmed, and mortality rate remains low. The response is co-ordinated nationally among all stakeholders, and not limited to just the healthcare sector. I feel that this holistic response will be the key to eventually overcoming this pandemic.

In your opinion, how will the COVID-19 pandemic impact the future of healthcare and interventional radiology?

This pandemic will have a deep impact on the future practice of healthcare.

Much like how we in Singapore have learnt from SARS, which changed our practice and infrastructure to cater for future disease outbreaks, we now have to start thinking about the ‘new clinical practice norm’ in the post COVID-19 era by learning from our current experience.

This pandemic has created a global crisis and brought significant suffering upon millions of people, but I am confident that we will find a way to overcome it and emerge stronger, better, and more resilient.

Tan Bien Soo is chair of the Division of Radiological Sciences, and senior consultant, Department of Vascular and Interventional Radiology at Singapore General Hospital, Singapore.

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Bedside IVC filter placement

July 2020 | Issue 78

Bedside IVC filter placement by interventional radiologist in COVID-positive patient preserves PPE and avoids transporting patient through hospital Kevin Stadtlander Comment & Analysis Kevin Stadtlander outlines how his institution is benefitting from the “creativity” of interventional radiologists during the coronavirus pandemic, here providing a step-by-step account of a bedside inferior vena cava (IVC) filter placement for a COVID-19-positive patient in intensive care.

A

38-year-old male with past medical history of hypertension, admitted for complications of COVID-19, required mechanical ventilation and extracorporeal membrane oxygenation (ECMO). The patient developed an intracranial parenchymal haemorrhage felt to be related to ECMO, with fluctuating haemodynamics, while on intravenous (IV) heparin protocol.

After removal of the ECMO venous cannula from the right groin, the patient was also found to have right iliac vein and femoral deep venous thrombosis (DVT), as well as belowknee DVT. The patient was referred to interventional radiology (IR) for inferior vena cava (IVC) filter placement, with a contraindication to systemic anticoagulation due to his intracranial bleed.

Given the ongoing COVID-19 pandemic, we had already implemented a plan that included having a designated IR procedure room in the department.

Our IR plan included the directive to try to do as much as possible at beside in COVID-positive patients. For this IVC filter placement, we quickly mapped out both options, and decided to take the care directly to the patient room.

We located a portable C-arm with digital subtraction angiography (DSA) capability and did a trial in an empty intensive care unit (ICU) room to ensure that the C-arm would fit under the bed, and that images would be clearly visible through the ICU bed. These goals were both accomplished, but it did necessitate maximum ICU bed height to fit the C-arm. The COVID patient room was negative pressure and separated from

the hallway (considered dirty) by sliding glass doors. Since no true anteroom was available, we used the empty ICU room as a staging room across the hall. The entire procedure plan was first reviewed in a huddle with all team members.

We chose to have one IR physician and two radiology technologists in the room for the procedure. We were also accompanied by IR nurses (outside the COVID room), who helped with staging and acted as buddies for donning and doffing. The sterile procedure tray for the IVC filter was made up in a second empty ICU room and covered. Informed consent was obtained via telephone from a family member.

The IR physician and two technologists donned their personal protective equipment (PPE) and lead aprons in the staging room with the help of the nursing buddies. The C-arm, the C-arm monitor, and the ultrasound unit were covered with a plastic barrier, and then taken into the COVID-positive patient’s room by the “dirty” technologist (who was wearing full PPE, excluding sterile surgical gown and gloves). The second technologist (wearing full PPE and designated as procedure scrub technologist) then wheeled the procedure tray into the room, put on her surgical gown and gloves, and began prepping the patient’s left groin. We chose the left groin due to a thrombus in the right iliac vein, and in order to stay away from the head of the bed. The IR physician then entered the room, put on a sterile gown and gloves over full PPE, and helped to complete patient preparation.

Importantly, a step stool (covered in plastic) was used by the physician during

Kevin Stadtlander and two radiology technologists during the procedure

IR creativity allows for procedures to be performed ‘portably’.” the procedure, as bed height necessary for C-arm made this a requirement. Sign in/time out was performed, IVC filter placement was completed in 10 minutes, and sign out was performed. Throughout the procedure, the patient’s ICU nurse monitored the patient and controlled his IV sedation via drips that were outside the room as per COVID protocol.

The surgical scrub gowns and top layer of gloves were removed in the normal fashion in the room and discarded.

The procedure tray breakdown was quickly performed, and all items were disposed of in the room trash. Plastic wraps were removed from equipment and discarded in the room as each unit was moved from room to hallway.

Each unit was terminally cleaned with X-ray machine bleach wipes. Each of

the three caregivers then performed careful doffing of PPE (with our nurse buddies using a checklist) at the door threshold, ultimately leaving only N95 mask and bottom layer eye goggles on as they exited back to the staging room.

Lead aprons were removed and wiped down with a lead X-ray apron cleaner disinfectant. N95 mask and goggles were then removed, and caregivers were free to head to the surgical locker room for scrub change and shower. A debrief huddle with all team members was then performed.

This case illustrates how IR creativity allows for procedures to be performed “portably” at the bedside in a manner safe for both caregivers and patients, while having the added benefit of preserving PPE. By way of follow-up, this patient ultimately came off the ventilator, became COVID-negative, and a CT brain scan has since demonstrated resolution of the intracranial bleed.

The patient has been discharged from hospital.

Kevin Stadtlander, MD is an interventional radiologist at the Cleveland Clinic Florida, Weston, USA.

Neurointerventions

Issue 78 | July 2020

CIRSE calls for “further Europeanwide initiatives” to establish stroke thrombectomy training programmes for interventional radiologists Despite being “perfectly placed” to help meet the increasing demand for stroke thrombectomy, there is not an established training structure for interventional radiologists wishing to perform the procedure in Europe. The findings of a recent online survey conducted by the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) on stroke thrombectomy provide, according to the society, a “mandate [for] further European-wide initiatives” to establish such training programmes.

WRITING TO THE EDITOR of CardioVascular and Interventional Radiology, CIRSE past president Robert Morgan (St George’s University Hospitals NHS Foundation Trust, London, UK) et al state that current barriers to interventional radiologists becoming key players in European stroke management, identified by CIRSE leadership, include “the absence of an established training structure for interventional radiologists performing stroke thrombectomy, a strong dependence on local conditions, limited 24/7 coverage, as well as varying opinions on the desired involvement of interventional radiology [IR] in stroke thrombectomy”. Therefore, to assess the level of interest and involvement by interventional radiologists in stroke thrombectomy across Europe, CIRSE conducted

an anonymous online survey on the current situation of stroke thrombectomy practice among European interventional radiologists.

Stroke thrombectomy was performed in 74.5% of the respondent’s centres, with an expected predominance in university hospitals, tertiary care hospitals, and private hospitals, although the procedure was also performed in 52.5% of general hospitals. There was an increasing tendency for the procedure to be performed in larger hospitals.

In centres where stroke thrombectomy is performed, it was most frequently delivered by interventional radiologists in 70.1% and by neuroradiologists in 48%. Stroke thrombectomy was provided by both interventional radiologists and neuroradiologists in 21% of centres. “Collaboration with other specialties appeared to be good throughout the obtained sample,” the letter says, “as interventional radiologists perform stroke thrombectomies in collaboration with other medical specialties in almost 90% of centres.”

It continues: “Training for stroke thrombectomy

Delivery of stroke thrombectomy services by discipline

by interventional radiologists was either provided by a neuroradiologist at the same centre (47.7%) or was obtained by interventional radiologists independently (46.2%). However, opportunities for training in stroke thrombectomy are relatively limited for interventional radiologists, especially where there was reluctance by neuroradiologists to involve interventional radiologists in the stroke thrombectomy service, and almost a quarter of respondents who perform stroke thrombectomies indicated that they were ‘trained in another way’, indicating a large variety in training modes and options and reconfirming the need for more standardised training

Transradial access may be safer than transfemoral access for flow diversion to treat cerebral aneurysms Transradial, as opposed to transfemoral access, may be a safer approach for flow diversion procedures to treat cerebral aneurysms at a wide range of locations. This conclusion was reached by Yangchun Li from the University of Miami Miller School of Medicine (Miami, USA) and colleagues, as their retrospective study, published online in the Journal of NeuroInterventional Surgery (JNIS), found that both access site complication rate and overall complication rate were lower for transradial access flow diversion.

T

he investigators used a large multicentre registry to retrospectively analyse flow diversion cases for cerebral aneurysms from 14 institutions from 2010 to 2019.

Pooled analysis of proportions was calculated using weighted analysis with a 95% confidence interval (CI) to account for results from multiple centres. Access site complication rates and overall complication rates were compared

between the two approaches.

Of the 2,285 patients included in the study who underwent flow diversion, 135 (5.85%) were treated with transradial access, and 2,151 (94.14%) via transfemoral access. Li and the team reported that the two groups shared similar patient and aneurysm characteristics. “There were no access site complication in the transradial access group,” they write. However, they add

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pathways and dedicated courses for IR.” The survey also reported a broad consensus among respondents that “a significant growth in the demand for stroke thrombectomy was expected, due to factors such as improved infrastructure and service availability, increased awareness of this treatment option among referrers, better clinical evidence, and broader inclusion criteria”.

Speaking to Interventional News, Morgan says: “This survey confirms that in many countries, interventional radiologists already have a significant role in the delivery of intraarterial stroke therapy. This was already known by CIRSE but had not been confirmed previously by a formal survey of CIRSE members.

“We all know that there are not enough interventional neuroradiologists to provide intraarterial stroke therapy in Europe in the volumes that are required by patient demand for this procedure. I would like the future of stroke thrombectomy to be a comprehensive service satisfying the widespread demand by patients and delivered by doctors who have been adequately trained to perform the procedure. Interventional radiologists would be key players in the stroke thrombectomy service, working alongside our colleagues in interventional neuroradiology.

“To bring this about, we need to form even better collaborative working relationships with our interventional neuroradiological colleagues. These improved relationships should be encouraged by our colleagues and not hampered by any counterproductive issues such as turf. Another important requirement is the recognition by leaders of national health systems that interventional radiologists can provide stroke thrombectomy and should be encouraged to do so in their country’s hospitals.”

CIRSE received a total of 601 valid responses, which the society claims is “a very high response rate (11.5%) for a CIRSE member survey”. Of these, 109 came from Germany, 87 from Italy, 68 from the UK, 38 from The Netherlands, 36 from Turkey, 32 from Spain, 28 from Belgium, 26 from Austria, 25 from Greece, and the remaining quarter from other European countries—“the sample was considered to be representative of CIRSE’s European membership in terms of geographical spread, centre type, and level of experience”. However, the letter writers acknowledge a potential bias that interventional radiologists involved in stroke thrombectomy may have been more likely to respond.

that the rate of access site complications for the transfemoral approach was 2.48% (95% CI, 2.4–2.57%, vs. 0%; p=0.039).

Of note, one death resulted from a femoral access site complication.

The overall complication rate was also higher in the transfemoral group (9.02%; 95% CI, 8.15–9.89%) compared with the transradial group (3.73%; 95% CI, 3.13–4.28%; p=0.035).

Why the authors advocate for transradial access

These findings, Li et al say, help alleviate the apparent lack of neurointerventional literature directly comparing complication rates between the two approaches. Whilst the field of cardiology has conducted large randomised trials that have shown lower morbidity and mortality, as well as higher patient preference and cost reduction associated with transradial access, the same depth of investigation has yet to be applied to neuroendovascular medicine.

Moreover, Li and colleagues write: “Reducing access site complications is relevant to flow diversion for two reasons. First, flow diversion employs larger bore access systems, which may

increase the likelihood of access arterial injury, bleeding or occlusion. Second, prolonged dual antiplatelet therapy is administered to patients undergoing endovascular flow diversion along with heparin, which increases the risk of access site bleeding. Additionally, the smaller diameter of the radial artery raises the question of whether a transradial access approach is uniformly feasible for flow diverting procedures.”

The investigators state that the current study is “the largest series to date comparing transradial and transfemoral access for this type of neuroendovascular procedure”. Additionally, they argue that the study demonstrates a significant safety benefit with transradial access flow diversion, alongside the feasibility of treating both ruptured and unruptured aneurysms via transradial access at a wide range of locations.

The team surmise: “Combining both these findings with other benefits of transradial access, including high patient preferences, elimination of postprocedural bed rest and decreased cost, we continue to advocate for the transition to a radial-first approach for endovascular flow diversion.”

Market watch

Issue 78 | July 2020 Metastatic bone disease Primary lung cancer Renal cancer Superior vena cave (SVC) stenting for treatment of malignant obstruction Completing each course earns the participant CME (continuing medical education) credits.

Industry News Rexgenero acquires the key technology and programme assets of aratinga.bio SAS Group

Rexgenero, a regenerative medicine company developing advanced cell therapies to treat chronic limbthreatening ischaemia (CLTI), has announced the acquisition of all the key assets of aratinga.bio SAS Group, a preclinical-stage immunotherapy biotechnology company based in Paris, France.

The acquisition, which follows the recent approval by the French Commercial Court, includes all patent applications and related intellectual property, the exclusive license agreement for polymeric nanoparticle technology and the bioproduction facilities of aratinga.bio SAS Group, as well as the entire aratinga.bio team.

Straub Medical acquired

by BD

Straub Medical has approved a full acquisition by Becton, Dickinson and Company (BD). The acquisition was completed on 20 April 2020. Straub Medical manufactures, develops, and sells medical devices for the treatment of arterial and venous diseases that are used worldwide by vascular surgeons and interventional specialists in radiology, angiology, and surgery.

Gido Karges, CEO of Straub Medical, comments: “BD is the ideal strategic addition to Straub Medical. With its complementary product portfolio and established global sales channels, BD offers treatment solutions for vascular specialists around the world to advance the world of health.”

“With our extensive expertise in endovascular technologies and our strong global infrastructure, BD is the right company to offer Straub Medical products worldwide as an important building block of our modern treatment solutions,” says Steve Williamson, president of BD’s Peripheral Intervention business. “We are committed to improving the quality of life for the more than 200 million people worldwide who are affected by occlusive diseases of the peripheral arteries. We are also committed to providing more instruments for treating venous diseases. The acquisition of Straub Medical makes it possible to help physicians worldwide treat even more affected patients.”

ABR announces November dates for Core Exam

The American Board of Radiology (ABR) has announced that its Core Exam for diagnostic radiology (DR) and interventional radiology (IR/DR) will be held in November.

The ABR originally had the Core Exam scheduled for May and June, but it was forced to postpone the tests due to

CIRSE 2020 to take place online

the novel coronavirus outbreak. The new dates for the DR and IR/DR exams will be 5–6 November and 9–10 November, respectively, in Chicago and Tucson, USA. Eligible candidates for the exam will receive invitations no later than 24 August.

At the same time, the ABR said it is making progress toward scheduling the Medical Physics (MP) and Radiation Oncology (RO) oral exams in Tucson.

The organisation has identified new dates and is waiting for confirmation from the hotel where the exams will take place.

Finally, the American Board of Radiology said the MP and RO initial qualifying exams are scheduled to take place as planned in July and August.

Six CIRSE Academy courses currently free to access

The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) has made six of ts Academy courses free to access online.

On its website, the society states: “While much of our regular routines have come to a halt as a result of the current crisis, your IR [interventional radiology] education should not have to.

In an effort to support our community during these challenging times, CIRSE has now made six CIRSE Academy courses free to access. This offer is only available until 24 July, so do not wait up! Find the courses that interest you, add them to your cart and check out— you will be enrolled at no cost!

“In addition, CIRSE has made more than 190 lectures from CIRSE congresses of the past year, including ECIO, ET, and CIRSE 2019 available free of charge.”

The six online current courses currently available are: Hepatocellular carcinoma Management of acute arterial gastrointestinal haemorrhage

The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Annual Scientific Meeting will be taking place online 12–15 September. Read the full press release from the society below.

“It has been several months since the beginning of the COVID-19 pandemic and although infection numbers in some countries have declined, others are currently in the middle of experiencing the devastating effects of the virus.

The situation remains uncertain and as governments struggle to find ways to prevent a second wave of infections, we all have to accept the new situation.

Governments have imposed travel bans and strict limits on in-person meetings, which often means that we—at least for the time being—have to change the way we interact with others.

“It is for these reasons that the CIRSE Executive Committee has decided to hold CIRSE 2020 as an online event from September 12–15 instead of the physical meeting originally planned to take place in Munich. By offering a virtual event, CIRSE will provide a safe and reliable platform for knowledge exchange to IRs [interventional radiologists] around the world, regardless of the situation in their country or their ability to travel.

“We look forward to offering the usual high-quality sessions featuring the field’s top experts and the latest research further enhancing the evidence-base of our specialty. We would particularly like to thank our many faculty members for their patience and their unwavering commitment, as well as our corporate partners, who have been very supportive during the pandemic and will of course also form an important part of the CIRSE 2020 Summit.

“We invite all interested parties to access the CIRSE website, sign up for the CIRSE e-newsletters and join the CIRSE social media channels to stay up-to-date as we continue to plan an outstanding CIRSE 2020 Summit.

“We look forward to a lively knowledge exchange at the CIRSE 2020 Summit and to talking to you via its interactive platforms!”

RSNA launches online resource for COVID-19

The Radiological Society of North America (RSNA) launched a web page in April 2020 to help radiology

25

professionals amid the ongoing COVID-19 outbreak.

The COVID-19 Resources webpage includes guidance, research, and a collection of images to help radiologists and other professionals.

The society state: “RSNA is committed to connecting radiologists and the radiology community to the most timely and useful COVID-19 information and resources. Stay in the know. Get COVID-19 updates sent directly to your inbox. We will send you the most important announcements and useful resources to help you manage the COVID-19 public health crisis.”

GEST to take place virtually in September 2020

The Global Embolization and Oncology Symposium Technology (GEST) has announced that it will take place virtually this year. Previously planned to be hosted in New York, USA, on 2–5 September, the event will now be online from 4–6 September 2020.

In an email addressed to the “GEST Community”, the GEST course directors write: “After careful consideration, GEST 2020 will go Virtual to protect the health and safety of our global community.

“GEST Meets Virtual 2020 will include both live interactive virtual sessions and an on-demand e-library.

The GEST committees and faculty have been working diligently finalizing the virtual program. Stay tuned over the next week for the updated program!

“Our commitment to global education, innovation, research and improving patient care is stronger than ever. Please join us and take advantage of all the virtual content GEST has to offer. We hope you will join us virtually in September.”

MHRA: Warning to be added to paclitaxel device IFUs in Europe In a field safety notice, the UK Medicines and Healthcare products Regulatory Agency (MHRA) stated that a warning and clinical summary section will be added to the instructions for use (IFU) of 12 paclitaxel-coated balloons and paclitaxel-eluting stents used in the treatment of peripheral arterial disease (PAD) of the lower limbs.

The medical devices that will be affected by the changes are BioPath (Biosensors International), ELUVIA (Boston Scientific), IN.PACT Admiral (Medtronic), IN.PACT Pacific (Medtronic), Luminor (iVascular), Lutonix (BD), Passeo-18 Lux (Biotronik), Ranger (Boston Scientific), Ranger SL (Boston Scientific), SeQuent Please OTW (B Braun), Stellarex (Philips), and Zilver PTX (Cook Medical).

Market watch

Issue 78 | July 2020

Clinical News Temporary spur stent system

Enrolment begins in DEEPER LIMUS study of Reflow Medical’s temporary spur stent system

The first patients have been enrolled in the single centre DEPPER LIMUS clinical trial, Reflow Medical has announced. The non-randomised pilot study will evaluate the temporary spur stent system for the treatment of lesions in the infrapopliteal arteries using a limus-based drug-coated balloon.

According to the company, the DEEPER LIMUS study is expected to enrol up to 30 patients for approximately six months at a single centre outside the USA. It will follow primary and secondary endpoints for safety and efficacy.

“This gives us an opportunity to truly understand how differently anti-restenotic drugs can treat infrapopliteal disease,” the trial’s principal investigator Marianne Brodmann (Medical University of Graz, Graz, Austria) comments. “The unique design of the spur device may enable the antiproliferative drug to reach the medial layers of the arterial wall, without leaving anything behind, and minimising the need for follow-up procedures.”

The retrievable temporary spur stent system is designed to treat long, diffuse, and severely calcified infrapopliteal disease. The device has a series of radially expandable spikes intended to create multiple pathways to allow the increased uptake of antiproliferative drugs into the vessel wall and facilitate acute luminal gain, without leaving anything behind, state Reflow Medical.

First case completed in STAND study, the pivotal clinical trial of MicroStent

Micro Medical Solutions has announced the first implantation of the MicroStent vascular stent in the US Food and Drug Administration (FDA) randomised, multicentre pivotal clinical study, STAND (A Clinical Evaluation of the MicroSTent PeripherAl Vascular SteNt in subjects with Arterial Disease Below the Knee). The 25 leading medical institutions and outpatient centres designated across the USA are now enrolling patients in STAND. The first procedure was performed 25 March 2020 by the study’s lead investigator, Robert E Beasley of Mount Sinai Medical Center in Miami Beach, USA. “With a very successful MicroStent procedure and positive early results from the feasibility study showing a 90.9% patency rate at one

year, I am delighted that the STAND study is now underway,” Beasley comments. “MicroStent offers hope for limb salvage, better health and quality of life to patients at risk for below-theknee amputation, and the clinical trial will bring us closer to offering this new solution to thousands more candidates.”

MicroStent is a vascular stent, with both a 3Fr and 4Fr delivery system that allows for multiple access points, designed to achieve and maintain vessel patency and improve blood flow in order to reduce below-the-knee amputations for patients with critical limbthreatening ischaemia (CLTI) resulting from peripheral arterial disease (PAD).

Micro Medical Solutions received Investigational Device Exemption (IDE) approval from the FDA after completing a three-centre, 15-patient feasibility study in which MicroStent met all primary endpoints for both safety and efficacy. When complete, the STAND study will include approximately 177 patients at up to 25 sites across the US. MicroStent has already obtained CE mark approval for use outside the USA. Micro Medical Solutions CEO, Gregory Sullivan, adds, “Our leadership team and scientific advisory board have worked diligently to design and plan the STAND trial, with encouraging response from the FDA every step of the way. This first case is a source of great pride and inspiration as we continue to work toward FDA approval, which will help save many patients with CLTI from the devastation of below-the-knee amputation.”

First patient enrolled in Dragon trial investigating double vein embolization

The first patient has been enrolled in the Dragon trials, investigating the safety and feasibility of a novel, double vein embolization procedure in the treatment of patients with colorectal liver metastases.

Resection of liver metastases from colorectal cancer improves survival compared to chemotherapy alone and may lead to cure in up to 40% of patients. Commonly, the volume of the future liver remnant post-resection is too low to carry out the procedure, and liver growth needs to be stimulated to reduce the risk of post-procedural liver failure.

Portal vein embolization (PVE) is the current gold standard for inducing liver regeneration prior to resection of liver metastases in patients with colorectal cancer. However, the triallists propose that as embolization of both the portal vein and the hepatic vein on one side

of the liver leads to “faster and more extensive” liver growth, it could be an alternative to PVE. To test this hypothesis, the investigators are conducting an international, prospective, multi-centre pre-trial—Dragon 1—to explore the safety and feasibility of the double embolization approach, and to test enrolment capacity. All participating centres have to include three patients.

Currently, four centres are fully initiated into the study, nine have ethical approval but are not yet initiated, and a further 27 are awaiting ethics approval. Dragon 1 will then form the basis of a randomised controlled trial comparing PVE with hepatic vein embolization (HVE) to PVE alone—Dragon 2. Dragon 2 is expected to start in 2021.

Describing the combined embolization option, the clinicaltrials.gov page for the two Dragon studies notes: “PVE/HVE combines simultaneous embolization of the portal main branches into the

Erik Schadde and Christoph Binkert

tumour-bearing liver and the hepatic vein draining them. The tissue in the part of the liver treated with PVE/HVE stays viable because the hepatic artery continues to supply the liver deprived of portal and hepatic veins.”

Speaking to Interventional News, Christoph Binkert (Kantonsspital Winterthur, Winterthur, Germany), the international coordinating investigator for interventional radiology in the Dragon trials, comments: “The first double vein embolization in the Dragon 1 trial went very well. From our clinical experience, we always treat the right portal vein first in order to have good antegrade flow within the portal vein.

We used a mixture of Lipiodol [Guerbet] and Glubran [Gem] as an embolic agent.

In the same session, the hepatic veins were embolized with Amplatzer plugs.

There were two main right hepatic veins and a prominent vein draining segment six, which was also embolized. The patient tolerated the procedure well and left the hospital the same afternoon.”

Earlier preclinical studies in pigs have demonstrated the feasibility of this method, and human case series show accelerated and increased liver growth.

Binkert enthuses: “The Dragon trial is a true international and interdisciplinary trial researching the potential of double vein embolization. The idea is to reach a faster growth of the future liver remnant without additional risks to the patient.

After several months of intensive preparation, it is good to finally get patients involved. I am convinced that

27

soon other centres will also start enrolling.”

Positive two-year data from ALPS registry of LimFlow system published

LimFlow SA has announced publication of positive two-year data from the ALPS registry of the LimFlow percutaneous deep vein arterialisation (pDVA) system.

Results were published in the Journal of Endovascular Therapy.

The ALPS Registry is the largest study to date of no-option chronic limbthreatening ischaemia (CLTI) patients treated with the LimFlow system reporting mid- and long-term results.

“In this complex group of patients, pDVA using the LimFlow device has shown to be feasible and safe with high technical success and good amputationfree survival at six months up to 24 months coupled with good wound healing,” says the paper’s lead author, Andrej Schmidt (University Hospital, Leipzig, Germany). “In selected patients with no-option CLTI, pDVA is a safe and effective treatment to prevent amputation and heal wounds.”

“Patients with this disease suffer with chronic ulcers, often including gangrene, recurrent pain, and a very poor quality of life. CLTI is associated with poor mid- and long-term survival, and no-option patients often face the worst outcomes,” comments Roberto Ferraresi (San Carlo Clinic, Milan, Italy), co-author of the paper. “These patients desperately need an option to avoid amputation and improve their life, and LimFlow offers a very promising alternative for them.”

The ALPS Registry is a multicentre, retrospective study conducted at centres in Alkmaar, The Netherlands; Leipzig, Germany; Paris, France; and Singapore encompassing 32 end-stage—or “nooption”—CLTI patients.

All patients had non-healing wounds on the target foot and no arterial target for surgical or endovascular revascularisation. Among them, 66% had diabetes, 53% had renal insufficiency, and 16% were dialysis dependent. The majority of patients had experienced failed prior attempts at revascularisation.

The registry reported major amputation-free survival of 84%, 71%, and 67%, respectively, at six months, one year and two years. Additionally, a positive trend of successful wound healing was demonstrated, with 73% of wounds completely healed at two years.

Technical success was 97%.

“It is very gratifying to see these durable results being demonstrated by the LimFlow system in a real-world setting with consecutive patients,” says LimFlow CEO Dan Rose. “For these no-option patients, the next intervention for their leg was going to be major amputation, with the associated morbidity and high mortality risk that comes with amputation. Instead, two years later, the vast majority of patients are alive, with almost three-quarters of them experiencing completely healed wounds.”

Market watch

Issue 78 | July 2020

Product News

Advance Serenity PTA catheter

INFINITY Angioplasty Balloon Catheter receives 510(k) clearance

The Infinity Angioplasty Balloon Company has announced that its balloon platform—the INFINITY Angioplasty Balloon Catheter—has been cleared by the US Food and Drug Administration (FDA) for percutaneous treatment of peripheral arterial disease.

“The INFINITY catheter represents a game changing innovation in percutaneous angioplasty balloon design and utility,” states founder and vascular surgeon, John Pigott. “A single SKU to treat lesions from 40–250mm in length, is adjustable, to the millimetre, in vivo assuring Precision Angioplasty, while addressing over 95% of real-life clinical cases.”

“Adopting the INFINITY platform reduces inventory needs and costs from dozens of SKU’s to two, it reduces space requirements, inventory management time, and trunk stock, while delivering the assurance that the right balloon size will always be on the shelf—INFINTY is a highly differentiated product,” reports CEO Gary Smith. “This is an ideal product for both office-based labs and hospitals.”

While initially launching an uncoated angioplasty balloon, the company intends to follow quickly with a drug-coated balloon platform of similar design.

Surmodics receives CE mark for its SurVeil drug-coated balloon Surmodics recently announced it has received CE mark certification in the European Union for its SurVeil drugcoated balloon (DCB).

“I am excited about the potential of the SurVeil DCB to improve the treatment of PAD,” said Professor Marianne Brodmann, interventional cardiologist at Medical University Graz (Graz, Austria) and a principal investigator in TRANSCEND, Surmodics’ pivotal clinical trial for the SurVeil DCB. “Drug-coated balloons have been widely utilised in Europe as a frontline treatment for PAD.” The SurVeil DCB, a next-generation device that utilises best-in-class technology in the treatment of peripheral artery disease (PAD),

includes a proprietary drug-excipient formulation for a durable balloon coating and is manufactured using an innovative process to improve coating uniformity. Preclinical data have shown a more evenly distributed and durable drug effect, and lower incidence of downstream drug particles compared to the control drug-coated balloon.

“This CE mark is a critical milestone and an exciting step forward for Surmodics as we continue to demonstrate industry leadership in the development of pioneering vascular medical devices,” said Gary Maharaj, president and chief executive officer of Surmodics. “The design of the SurVeil DCB reflects our dedication to providing innovative solutions that bring real clinical value—benefitting both clinicians and the patients that they treat.

Congratulations go out to the entire Surmodics team on this well-deserved achievement.”

In February 2018, Surmodics entered into an agreement with Abbott that provided Abbott with exclusive worldwide commercialisation rights for the SurVeil DCB. Pursuant to the terms of the agreement, Surmodics received a US$25 million upfront payment and a US$10 million milestone payment for the completion of patient enrolment in the TRANSCEND clinical trial. As a result of CE mark attainment, Surmodics will receive an additional US$10.8 million milestone payment. The company will recognise approximately US$6.5 million as revenue in its fiscal third quarter and could earn up to an additional US$45 million for future product development milestones.

Surmodics is not forecasting material revenue from the sale of its SurVeil DCB product over the remainder of its fiscal year ending 30 September 2020.

Under the agreement, Surmodics will be responsible for the manufacture and supply of clinical and commercial quantities of the product and will realise revenue based on initial product sales to Abbott as well as a share of profits resulting from third-party sales. The SurVeil DCB is not available for sale and is for investigational use only in the USA.

Lipidol Ultra-Fluid receives approval for use in cTACE by China NMPA Guerbet has announced the approval of an additional indication for Lipiodol Ultra-Fluid by the China NMPA (National Medical Products Administration) for use in transarterial chemoembolization (cTACE) for hepatocellular carcinoma (HCC) at intermediate-stage in adult patients in the People’s Republic of China.

HCC is the most common primary liver cancer and the fourth biggest cause of death due to cancer worldwide. China alone represents more than 50% of all

primary liver cancers globally since the country has the highest liver cancer prevalence in the world according to the WHO with about 330 000 cases.

“Guerbet is honoured to receive the NMPA approval for this indication for Lipiodol Ultra-Fluid in China.

This registration reflects a strong positive endorsement from Chinese interventional oncologists and provides them with an additional NMPA endorsed therapy for managing patients with HCC in China. This is also evidence of our commitment to making cTACE available to as many HCC patients as possible.” commented David Hale, Guerbet’s CEO. “Development of image-guided procedures is a top priority for Guerbet’s Interventional Imaging Business Unit as we work to enhance liver cancer patients’ prognosis and quality of life in China and worldwide.”

Lipiodol Ultra-Fluid is used in interventional oncology for conventional transarterial chemoembolization, a minimally invasive procedure which consists of mixing Lipiodol Ultra-Fluid with an anticancer drug. The mixture is injected trans-arterially in the liver as a locoregional targeted chemotherapy for unresectable liver tumors (HCC).

Lipiodol UltraFluid acts as a contrast agent, a drug vehicle, and a dual arterioportal transient embolic.

For interventional oncology procedures, Lipiodol Ultra-Fluid is approved for cTACE indication in

Lipiodol Ultra-Fluid

EMEA (Austria, Belgium, Czech Republic, Denmark, France, Hungary, Iran, Ireland, Luxembourg, Portugal, Switzerland, the Netherlands, Tunisia, Turkey), in the Americas (Argentina, Colombia, Brazil, Chile, Mexico, Peru, Uruguay) and in Asia-Pacific (Australia, Brunei Darussalam, Cambodia, Hong Kong, India, Mongolia, New Zealand, Philippines, South Korea, Sri Lanka, Taiwan, Thailand, Vietnam).

Lipiodol Ultra-Fluid is approved for Imaging of patients with known HCC in the USA, in Canada and in Germany.

Lipiodol Ultra-Fluid is approved for adjustment of Epirubicin hydrochloride for transarterial injection in Japan.

New balloon catheter available in USA for use in the treatment of PAD patients

The Advance Serenity Hydrophilic percutaneous transluminal angioplasty (PTA) balloon catheter is now available to physicians in the USA. The catheter is manufactured by Surmodics and distributed by Cook Medical.

Advance Serenity is a hydrophiliccoated angioplasty balloon catheter

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designed to meet the technical needs of clinicians for treatment of patients who suffer from peripheral arterial disease (PAD) which includes belowthe-knee disease. The catheter portfolio includes both a 0.014- and an 0.018-inch diameter wire guide platform and will be available in a wide variety of balloon lengths and diameters.

“Now that we have added Advance Serenity to our product portfolio of vascular solutions, physicians have one more tool in their toolbox to help treat patients who have PAD,” says Mark Breedlove, vice president of Cook Medical’s Vascular division.

Cook Medical has said it is working to make Advance Serenity balloon catheters available to physicians in Europe in the coming months.

FDA clears Transit Scientific’s XO Score PTA scoring sheath platform

Transit Scientific has received US Food and Drug Administration (FDA) clearance for the XO Score percutaneous transluminal angioplasty (PTA) scoring sheath platform for use in iliac, iliofemoral, popliteal, infra-popliteal, and renal arterial plus synthetic and/ or native arteriovenous haemodialysis fistula.

Angioplasty is performed with expandable polymer balloon catheters to dilate stenoses, or narrowed, vessels.

Calcified, fibrous, and/or resilient stenosis may require special scoring or cutting angioplasty balloons with integrated wires or blades on the balloon. The added features focus and improve dilating force but result in large crossing profiles and limited deliverability while increasing cost and inventory, Transit Scientific said in a press release announcing the regulatory approval.

“XO Score transforms regular PTA balloons into scoring and cutting systems,” said Greg Method, president of Transit Scientific. “Clinicians insert an off-the-shelf PTA balloon into the XO Score tableside and then the system can be used over-the-wire to dilate calcified plaque and prep vessels.”

VasQ external support awarded breakthrough device designation by the FDA

The US Food and Drug Administration (FDA) has designated Laminate Medical’s VasQ external support for the creation of arteriovenous fistulas (AVF) in haemodialysis patients as a breakthrough device.

According to a press release, the designation was based in part on the breadth of clinical evidence collected so far for VasQ that consistently demonstrates improvement over the standard of care for creating functional AVFs for haemodialysis treatment.

“I have been anxious to get my hands back on VasQ ever since I reached the maximum enrolment for a site in the US clinical study,” said Jason Burgess of the Surgical Specialists of Charlotte (Charlotte, USA). “I am excited that

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Market watch

July 2020 | Issue 78

Product News the FDA has recognised the urgency we have as surgeons to improve the woeful outcomes that plague fistula creation.”

VasQ is currently in a US investigational device exemption (IDE) pivotal clinical study that is expected to have completed follow-up for its primary endpoints by August 2020 and will be evaluated by the FDA through the de novo pathway.

As of 4 February 2020, the singlearm study has prospectively enrolled its entire 144 male and female patient cohort from 15 sites across the USA. Both current and pre-dialysis patients referred for fistula creation where included in the study for either a brachiocephalic or radiocephalic fistulas with VasQ. The patients will be followed for two years with the primary efficacy endpoint of unassisted primary patency to be analysed at six months. The FDA will consider the results from the study as

well as the breadth of clinical evidence collected from use of the device around the world in its decision to grant US market clearance.

“This is a significant milestone for VasQ that will enable a faster and smoother regulatory process for the US market as well as support the necessary reimbursement for the use of the device in clinical practice to benefit patients,” stated Orit Yarden, vice president of Clinical and Regulatory Affairs for Laminate.

Transluminal biliary biopsy forceps set and Zilver 635 biliary stent now available in USA

The Transluminal Biliary Biopsy Forceps Set (BBFS) and a new 40-centimetre delivery system line extension of the existing Zilver 635 Biliary stent (both from Cook Medical) are now commercially available in

The Transluminal Biliary Biopsy Forceps Set

the USA. “We are excited to make these products available to physicians to provide more treatment options for biliary duct procedures. This continues our efforts to bring products to physicians that fill the unmet clinical needs for patients,” comments Mike Williams, director of Cook Medical’s vascular programmes.

According to a company press release, the Transluminal Biliary Biopsy Forceps Set is designed to facilitate percutaneous acquisition of accurate tissue samples

for biopsy.

Cook Medical go on to state that biopsy samples obtained during biliary procedures “must be sufficient and precise to reflect accurate diagnosis”.

BBFS was developed to include an introduction system coupled with a “cup and jaw” forceps design to retrieve biopsy specimens.

Supporting the use of the BBFS design, a study published in Cardiovascular and Interventional Radiology reported a 94.2% diagnostic accuracy, with appropriate technique, when evaluating malignant biliary strictures using BBFS. The Zilver 635 Biliary Stent is designed for cases of abnormal constrictions of the biliary tree (biliary neoplasms). The product helps to restore the natural flow of the biliary duct system, Cook Medical claims in a statement on the product launch.

The flexible stent is also resistant to shortening, helping to provide precise placement.

Having a 40-centimetre long delivery system permits ease of access for placement of the stent in biliary neoplasms.

Calendar of events 15–19 July European Society of Radiology (ESR) Annual Meeting Virtual www.myesr.org

2–5 September Global Embolization Cancer Symposium Technologies (GEST) US Virtual www.embolization.com

8–11 September CX Aortic Vienna Virtual event www.cxsymposium.com/cxaortic

12–15 September Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Annual Meeting 2020 Virtual event

2–4 December British Society of Interventional Radiology (BSIR) Annual Meeting 2020 Glasgow, UK

17–20 January International Symposium on Endovascular Therapy (ISET) Hollywood, USA

www.bsir.org/meetings

www.iset.org

9–11 October Symposium on Clinical Interventional Oncology (CIO) Miami, USA

16–18 December The International Conference on Complications in Interventional Radiology (ICCIR) Vienna, Austria

26–29 January 2021 Leipzig Interventional Course (LINC) Leipzig, Germany

www.theiomeeting.com

www.cirse.org/events/iccir

2–5 November European Conference of Interventional Oncology (ECIO) 2020 Nice, France

16–19 December European Conference on Embolotherapy (ET) 2020 Vienna, Austria

www.ecio.org

www.etconference.org

www.cirse.org/events

www.leipzig-interventional-course.com

5–8 February 2021 Society of Interventional Oncology (SIO) Annual Meeting San Francisco, USA www.sio-central.org

Event details correct at time of publication. Please check www.interventionalnews.com/events for updates in the wake of COVID-19.

Mar

Issue

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ues’ report with and colleag Katsanos ed mortality signal al an increas in the femoropoplite r 2018, paclitaxel 6 Decembe published arteries and meta-

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AGUES learning with a random analysed at it was compellinFDA evaluation is focusingwith data the g machine AND COLLE patient death, differences were pooled trials integratin LETZEN The ongoing ent, AI can risk d controlled in IR: “By wrote. preliminary ratios and randomise evidenced vision of AI , treatment, and managem uality the authors on US-based can validate. The FDA’s reported by trials have the highest-q effects model,” body ed controlled signal significantly into diagnosis s to provide that meets regulatory the mortality said the FDA’s physician Previous randomis balloons and stents lesion confirmed efficient manner Whereas empower -coated and target at VLF, Buckley (PMA) trials evaluation care in an that paclitaxel of vessel restenosis al. Speaking t approval tal clinical practice. personalised ysis interventions.

Katsanos et rates pre-marke of modern on incremen extremity ed of five US reduce the it [the meta-analall after lower the demands traditionally focused (28 randomis own analysis to where we feel like for a new has d between revascularisationall-cause patient death t we still have , AI allows medicine was similar research, has “converge a statistical glitch—bu rapidly analysed vs. all the statistical At one year, not 4,432 patients) hypothesis-based‘big data’ can be have arms (2.3% n as well with findings] is trials with and control where us informatio years controlled that may otherwise paradigm -coated devices death at two this incongruo have gone through.” new insights USA) called was , trials.” paclitaxel ng All-cause 17 ve we uncoveri risk of death). trials with 2,316 patients) of prospecti the data analysis that Peter Schneider (Honolulu of 2.3% crude g to review the Society vs. control required decades Also at VLF, ed controlled is undertakin paclitaxel meeting of year features deaths (12 randomis in case of that the FDA and spot on”.

[SIR] this The annual vs. 3.8% [35 the process tly increased providers Radiology interventional rward patients] ional significan healthcare straight-fo 1,397 eeded-to, in to Intervent a letter deaths in number-n “judicious learning IR summit FDA issued evaluating the “recent (7.2% [101 risk of death, Long-term its first machine and the BOLD-A Indeed, the long-term it was CI: 19–59]). patients] crude April, New ed session, stating that for increased - in 919 NYU (24 patients [95% years (three randomis oncology in January the potential or paclitaxel [NNH]: 29 Stanford and five in y and ethical by to balloon harm up n regarding further regulator initiated death informatio increased paclitaxel-coated pliteal artery for will tackle risk of all-cause with 863 patients) for AI research. on page 4 following York, USA) in 529 patients] mortality” trials in the femoropo(PAD). The agency g to data use Continued deaths out controlled treatments of death, (14.7% [78 issues pertainin crude risk eluting stent arterial disease FDA case of paclitaxel in 334 patients] peripheral ongoing, the treated deaths patients with the data review was vs. 8.1% [27 ce” for patients [95% CI: 9–32]).that meta-regression 2 that said that whilst d surveillan in the letter on page NNH: 14 patientscolleagues wrote ds “continue body stated for Continued recommen Katsanos and . The regulatory to outweigh the risks” with paclitaxel continue the “benefits indications. it believes within their approved devices

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