Interventional News Issue 83—September 2021 Edition by BIBA Publishing

September 2021 | Issue 83

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Featured in this issue:

Alison Halliday: ACST-2 Fiveyear results

CAVA RCT delivers powerful evidence supporting use of PORTs to supply systemic chemotherapy For most patients receiving systemic anticancer treatment (SACT), totally implanted ports (PORTs) are more effective and safer than both Hickman-type tunnelled catheters (Hickman) and peripherally inserted central catheters (PICCs). The CAVA trial’s results, recently published online in The Lancet, recommend reshaping current guidelines and practice, so that most patients requiring chemotherapy for solid tumours receive a PORT within the UK National Health Service (NHS), foreshadowing a pivot in practice that might be “slow to start with”.

he CAVA (Central venous access devices for the delivery of systemic anticancer therapy) trial is a National Institute for Health Research- (NIHR-) funded open-label, multicentre, randomised controlled trial that compared complication rates and costs of the three devices used to deliver anticancer drugs via a central vein. Reported to be the largest randomised trial to date to compare all three devices, CAVA set out to establish acceptability, clinical and cost-effectiveness of the devices for patients receiving SACT for three months, or more.

Profile: Maureen Kohi

“The bottom line is, for a solid cancer, if you are going to need intravenous chemotherapy for three months or more, you should be offered the option of a PORT. We should try and empower patients so that that this will be something they think will be best for them,” Jonathan G Moss (Institute of Cardiovascular and Medical Sciences, Glasgow, UK), chief investigator, tells Interventional News on the subject of increased PORT take-up. The paucity of good evidence comparing central venous access devices (CVADs) entails that neither the

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European Society of Medical Oncology these devices enabling prompt placement (ESMO nor the American Society of and removal by nurse-led teams, local Clinical Oncology (ASCO) make specific availability of devices, technical issues recommendations regarding the type of such as the avoidance of the vital device to be used. structures in the neck, and perceived CAVA showed that PORTs were lower up-front costs—but there is a associated with a reduction in sketchy evidence base behind this uptick, complication rate of about 50% when the authors say. “PORTs, by contrast, are compared to a PICC line, and the most expensive and least when compared with the frequently used of the three Hickman line. “There was a devices,” Moss emphasises. fairly strong preference for On stemming the tide of PORTs, amongst both the PICC use, the lead author patients receiving them and also continues: “Changing policy the healthcare staff who look in institutions like the after them. These were basically NHS is never easy. There felt to be better devices and the will be all sorts of reasons only downside is the cost and why people do not want to Jonathan G whether these services are set change—with costs being Moss up and geared to deliver these one and who is going to be devices compared to the other putting in the PORTs [being two in a timely manner,” Moss added. another], and how quickly they can be put in. […] There are lots of nurse teams Resetting UK practice may at the moment who have been trained to not be a brisk business place PICC lines. We need to be able to With the exception of five patients in sell the message to them that we are not the PORT group who received a general saying they should not provide a service anaesthetic, all devices were inserted for patients, but trying to persuade them under local anaesthetic. to put in a different device. I think we Moss outlines that decision-making need to try and move away from doctors processes behind the choice of device putting in the PORTs and nurses putting are “poorly understood” globally. in the PICC lines. These are all fairly Eye-catchingly, PICC use has been straightforward procedures to place, captured to be buoyant. “PICC usage has and I have great confidence that we can increased over the past decade and is now empower nursing teams to place all three the dominant strategy in many western devices, but particularly PORTs.” European countries and the USA.” Moss acknowledges that the This spike in PICC popularity may be underpinned by the ease of insertion of Continued on page 2

Wesley hospital becomes first in Australia to achieve IASIOS accreditation in historic global milestone for CIRSE Ten centres have achieved the International Accreditation System for Interventional Oncology Services (IASIOS) accreditation, a benchmark of quality standard and assurance, since 2018. I-MED Radiology, The Wesley Hospital, has just achieved this recognition to become the first clinic in the Southern Hemisphere to do so. Interventional News speaks to Nicholas

CX Aortic Vienna Teams, not silos

COMMENTING ON THE MAIN BENEFITS HE foresees as a result of being granted this recognition, Brown says: “The IASIOS accreditation will allow our centre to promote our high standards to patients, referrers and hospital administrators. The process of seeking IASIOS accreditation allowed us to review and critically appraise our existing practices, and to ensure that how we work is aligned with the international standard. The promise of accreditation provided us with the motivation to examine every facet of our practice, including areas where we needed to improve to comply with the IASIOS requirements.”

Brown (clinical director at I-MED, The Wesley Hospital, Queensland, Australia) on this achievement and how it certifies that this hospital is providing the highest standards of interventional oncology (IO) care. “Personally, I am convinced that IASIOS will bring game-changing renewal and evolution to interventional radiology practice around the world,” he says.

Continued on page 4

September 2021 | Issue 83

Interventional Oncology

CAVA RCT delivers powerful evidence supporting use of PORTs to supply systemic chemotherapy Continued from page 1

complication rates and costs of nurse-led teams placing PORTs was not tested by CAVA, but emphasises that most skill mix is not evidence-tested. “We did not compare different operator groups regarding complication rates as that was not the purpose of the trial. We do know the technical (or periprocedural) complication rates in CAVA were exceptionally low, reflecting well-trained staff using ultrasound guidance. Most of the complications related to these devices arise from their subsequent usage and maintenance. We simply do not have enough events to compare periprocedural complications across operator groups and have no reason to believe, based on this very low complication rate, that any one group (nurses, anaesthetists or radiologists) was technically better than another. We continue to support the concept of nurse-led vascular access teams in order to make widespread practice change practical to deliver.” The authors back the challenge “to change the service delivery model so that PORTs can be provided in a more timely and cost-effective manner. There will still be a small group in whom the other devices are preferred. Guidelines should be updated to reflect this new evidence,” they write. They also probed the issue of cost, which is another factor that will play into service transformation. “We have got to persuade the people that pay for these, the managers, that although the PORT is more expensive at the shop front, at the end of the day, when you look at the total package of care [when dwell time is taken into account], that they actually are no more expensive, or a little bit cheaper. And again, that is sometimes difficult to sell in the NHS because we tend to focus on frontline costs,” explains Moss.

Four-way randomisation in CAVA

CAVA randomised patients with an algorithm taking into account centre, body-mass index, type of cancer, device history, and treatment mode. The trial included adults receiving SACT over a three-month or longer period for solid or haematological malignancy from 18 oncology units in the UK. There were four available randomisation options: Hickman vs. PICCs vs. PORTs (2:2:1), PICCs vs. Hickman (1:1), PORTs vs. Hickman (1:1), and PORTs vs. PICCs (1:1) and these then allowed three 2×2 comparisons, PICC vs. PORT, PICC vs. Hickman and PORT vs. Hickman, to be made. “The primary outcome was complication rate (composite of infection, venous thrombosis, pulmonary embolus, inability to aspirate blood, mechanical failure, and other) assessed until device removal, withdrawal from study, or oneyear follow-up,” the authors report in The Lancet. The triallists screened 2,714 individuals for eligibility, 1,061 were enrolled and randomly assigned (PICC vs Hickman n=424, 212 [50%] on PICC and 212 [50%] on Hickman; PORT vs Hickman n=556, 253 [46%] on PORT and 303 [54%] on Hickman; and PORT vs PICC n=346, 147 [42%] on PORT and 199 [58%] on PICC).

PORTs outpace other CVADs on nearly all fronts

Between 2013 and 2018, 1,061 patients were enrolled and randomly assigned (PICC vs. Hickman n=424, 212 [50%] on PICC and 212 [50%] on Hickman; PORT vs. Hickman n=556, 253 [46%] on PORT and 303 [54%] on Hickman; and PORT vs. PICC n=346, 147 [42%] on PORT and 199 [58%] on PICC). ■ Similar complication rates were observed for PICCs (52%) and Hickman (49%). ■ PORTs were superior to Hickman with a complication rate of 29% vs. 43%. ■ PORTs were superior to PICCs with a complication rate of 32% vs. 47% Painting a picture of the trial’s main findings, Moss and colleagues report: “There was little difference between PICCs and Hickman in terms of complications. CAVA showed that PORTs reduced the adverse event rate by approximately 50% compared with Hickman and PICCs. A device specific quality of life instrument showed no difference between PICCs and Hickman, but a preference for PORTs. PORTs were associated with the highest total costs; however, after allowing for the dwell time of the devices, there was no difference between PICCs and Hickman, but the cost associated with PORTs was lower when compared with PICCs and Hickman.”

The latest from the interventional world

n NEW PACLITAXEL METAANALYSIS: “There appears to be heightened risk of major amputation after use of paclitaxel-coated balloons in the peripheral arteries,” findings from a systematic review and meta-analysis of randomised controlled trials published in the European Journal of Vascular and Endovascular Surgery suggest, based on moderate level evidence.

For more on this story go to page 17. n TARGET LESION REVASCULARISATION DRAWS FIRE AS CLINICAL ENDPOINT: Is target lesion revascularisation (TLR) a meaningful clinical endpoint for research or should it be “tossed as a legitimate endpoint for peripheral vascular disease treatment success in US FDA [Food and Drug Administration] approval trials?” Recent keynote presentations and conference debate on appropriate care for peripheral vascular disease leave overuse of interventional therapy, particularly for claudication, staring down the end of a barrel.

For more on this story go to page 18.

Snapshot of central venous access device placement With the exception of five patients in the PORT group who received a general anaesthetic, all devices were inserted under local anaesthetic

Radiologists

Nurses

Anaesthetists

Hickman lines

46–48%

23–35%

13–20%

PICCs

11–13%

67–73%

3–4%

PORTs

59–78%

2–24%

10–11%

Most commonly placed by:

News in brief

n NO DISTENDED VEIN, NO GAIN FOR SURGICAL AND “ENDO” AVFS: Fist Assist Devices has announced completion of the FACT trial, which evaluated the use of an intermittent pneumatic compression device to promote vein dilation in patients with kidney disease. The trial’s results suggest the device, model FA-1, could enable an increase in the creation of functional arteriovenous fistulas (AVFs) by enlarging superficial veins. Meanwhile, Artio Medical announced in late July that it has completed enrolment in its first-inhuman study evaluating the Amplifi vein dilation system.

For more on this story go to page 31.

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September 2021 | Issue 83

Quality Assurance

Wesley Hospital becomes first in Australia to achieve IASIOS accreditation in historic global milestone for CIRSE Continued from page 1

Interestingly, this landmark achievement traces a trajectory that has come a full circle having started in Australia. The Royal Australian and New Zealand College of Radiologists (RANZCR), through Liz Kenny (one of its past presidents), started this process by providing a set of standards for quality assurance in radiation oncology to the Cardiovascular and Interventional Radiological Society of Europe (CIRSE), which used them as a template for quality assurance standards in IO. Brown is categorical about what prompted I-MED Radiology at the Wesley Hospital to undergo the rigorous IASIOS accreditation process. “The IO service offered at the Wesley Hospital has always

IASIOS […] provides an easy riposte to any outdated attitudes from colleagues who doubt the notion of IRs being true clinicians. If ever we needed proof that IRs are clinicians and not just technicians, IASIOS provides it in abundance.” been comprehensive and progressive, and the IASIOS accreditation now provides us with an opportunity to ensure that our practices are benchmarked against an international quality standard. IASIOS accreditation provides us with the confidence that we are providing the highest standard of care, and will allow us to adopt new and evolving technologies within a quality framework. Furthermore, it will provide confidence to patients and referrers that our centre can be trusted to deliver the best possible care.” The IASIOS award, in addition to being the bright line that separates centres that deliver top quality IO care, has wider implications for the growth and development of IO in Australia and New Zealand. Brown elaborates: “Quality assurance and quality control in interventional radiology and IO is critical. ‘Quality’ is the yardstick by which specialty practice is measured and judged by our clinical colleagues, and demonstrates a mature, professional approach to clinical care. The IASIOS system in Australia will help to ensure that quality standards remain a guiding light as interventional radiology and IO evolve. It particularly demonstrates that specialist IRs should be equals in the multidisciplinary team environment. Quality assurance is the mark of a true clinical speciality, and an accreditation programme that seeks to uphold standards of practice is a tremendous boost towards promoting these in interventional radiology. IASIOS is an effective tool that legitimises the high standards that we all strive for day-to-day, and provides an easy riposte to any outdated attitudes from colleagues who doubt the notion of IRs being true

clinicians. If ever we needed proof that IRs are clinicians and not just technicians, IASIOS provides it in abundance.”

difference and enables us to provide excellent quality care.” An 18-month process, involving hard work and contributions from clinical, A challenging process, nursing, technical, administrative huge achievement and managerial staff culminated and the team’s in a successful accreditation. unforgettable reaction “The whole team was absolutely The IASIOS process is thrilled and rightly proud challenging, as is appropriate Assuring high-quality IO care of this achievement and the for a system designed to set and recognition that it brings. maintain high quality standards (see box). “It provided The affirmation of our high standards of practice a thorough analysis of work practice and required an is both reassuring and motivates us to continue to in-depth review of every part of what we do and how we improve and evolve. We are also very pleased to be interact with patients, referrers and the broader hospital able to share this exciting news with our patients setting. The process also takes longer than anticipated. and referrers, as we look to grow not only our Not all the information required for a successful practice, but represent the capabilities of the broader application will necessarily be readily available, and interventional radiology profession,” says Brown. may have to be reviewed, reproduced or re-written. A Specifically addressing other global centres who critical component—the case audit—is an opportunity might wish to undertake the accreditation process, to demonstrate the depth of specialty practice but it Brown says: “It is good to remember that persistence requires time to compile all the necessary aspects. will pay off, eventually. The Accreditation Certificate The IASIOS process definitely requires a team is just reward for a great effort and lots of difficult effort, but also needs one or two local champions work. Attaining and promoting high quality who can take responsibility for the process standards in clinical care are important ways of and spearhead progress towards a completed supporting your practice and your profession. application. A leadership team that involves “We are extremely grateful to CIRSE clinical, nursing and administrative insights for embarking on the IASIOS journey, is very important. I would like to pay and personally I am convinced it will bring special tribute to our nurse co-ordinator, game-changing renewal and evolution to Stephanie Castree, who was instrumental in interventional radiology practice around the getting our IASIOS application together world. We are also thankful for the confidence and making sure everything was (and patience!) shown to us by CIRSE in done right. Having a dedicated having the Wesley Hospital as a pilot person like Stephanie in our site and encouraging us to complete clinic makes a significant the accreditation programme.” Nicholas Brown

CIRSE signposts the IASIOS process: What is the process of IASIOS accreditation?

The accreditation process begins once a facility has registered. By initiating the process, they receive the first seal—that of an IASIOS Enrolled Centre. With the first step, they have shown that they are dedicated to increasing the quality of the patient pathway in their IO service line. The goal of IASIOS is not to make a judgement on the quality of the department at the time of registration, rather it is to help the centre make the necessary adjustments and changes to bring their service to the level outlined in the core requirements of the Standards of Quality Assurance document. The centre can remain an Enrolled Centre for as long as necessary to make the changes and they can utilise the full support of the IASIOS team along the way. Each application is independently reviewed by two assessors who must both come to the same agreement that compliance has been demonstrated before the seal of IASIOS Accredited Centre has been granted. If there is any doubt on

the answers given in the application form, the facility will be able to provide additional documentation or the assessors may request a remote audit for a detailed discussion. After a centre has been an IASIOS Accredited Centre for four years, they have the option of becoming re-certified, or they can ambitiously aim to demonstrate compliance to every single standard outlined in the Standards of Quality Assurance document, which would grant them the IASIOS Centre of Excellence seal.

How does CIRSE guide centres across the globe through the process?

The IASIOS team is readily available for any questions that may arise or obstacles that may be encountered during the application process, whether by email or video call. We have manuals and guidelines that have been developed, and are constantly gathering feedback and information that we can collect and make available to the centres going through the accreditation process so they can learn from the centres that have gone through the process before them. We have been developing a system that is completely online and digitised so it can be easily

accessed by multiple people and multiple assessors regardless of time zone or location in the world. Our goal is to create a truly global community of people dedicated to advancing IO, learning from each other and increasing its quality of care and recognition. As the community grows further, we will be able to offer enrolled centres guidance from council members and consultants in all areas of the world. We received an overwhelmingly positive response from dedicated IO experts worldwide supporting this initiative and joining the IASIOS community as Council Members.

How many centres have achieved accreditation since the 2018 pilot phase?

From the 12 centres that participated in the pilot phase, 10 centres have achieved accreditation and two are undergoing accreditation. These include hospitals from Europe, Asia and the Southern Hemisphere, more specifically: The UK, France, Germany, Switzerland, Italy, The Netherlands, Turkey, Singapore and most recently—Australia. Since the launch of the scheme in April 2021, eight centres have initiated their enrolment and are awaiting administrative approval from their hospitals. These include hospitals from Canada, Switzerland, Italy, Germany, Austria, Sweden, the UK and The Netherlands.

September 2021 | Issue 83

In-person Proctoring

International training and outreach in the pandemic era Robert Morgan Comment & Analysis As we start to emerge from the strictures imposed by the COVID-19 pandemic, it is timely to reflect on the delivery of education and training to interventional radiologists (IRs) around the world, especially those living in countries with limited access to the educational opportunities that are generally available to interventionists in the more developed world, writes Robert Morgan (St George’s University Hospitals NHS Foundation Trust, London, UK).

Before COVID-19

Before the COVID-19 pandemic affected populations worldwide, several major international interventional radiology societies (Cardiovascular and Interventional Radiological Society of Europe [CIRSE], Society of Interventional Radiology [SIR] and Asia Pacific Society of Cardiovascular and Interventional Radiology [APSCVIR]) had spearheaded programmes to deliver education and training in several countries around the world. Some medical device companies had also begun their own initiatives sponsoring senior IRs to visit countries to participate in the training of the local IRs. The concept of training IRs travelling to less well-developed countries and systems—i.e. outreach training—had been going on for some years from the start of this millennium. In the last decade, we saw a significant increase in this practice with ever-larger delegations of training IRs visiting a wider number of countries. These outreach training programmes usually offered exposure to hands-on device training, and in some cases procedural training in addition to more formal teaching through lectures and small group tutorials. Where possible, the local outreach training experience was designed to complement standard training delivered by local senior IRs and online education and attendance at live educational events, where feasible, depending on the financial and political constraints of each country. Although quality education can be delivered remotely, in-person training such as can be provided by outreach training enables valuable interactions and discussions between training faculty and trainees that are difficult to replicate online. My recent experiences as an outreach training faculty in Myanmar serve to illustrate the benefits of inperson outreach training.

Outreach pre-pandemic

In both January 2019 and 2020, I travelled to Myanmar as a member of an intersociety collaborative endeavour to provide training and education in two interventional radiology outreach workshops. The workshops were organised by senior members of the APSCVIR with participating members from CIRSE and SIR in collaboration with senior Myanmar IRs. In each programme, workshops were held in Yangon and in Mandalay General Hospitals. Both hospitals are of moderately large size with over 500 beds each. Each of the radiology

was delivered at both workshops covering a wide range of interventional radiology procedures including transarterial chemoembolization (TACE), radiofrequency ablation (RFA) of liver tumours, uterine fibroid embolization (UFE), haemodialysis interventions, central venous access, lower limb arterial interventions, urological interventions, hepatobiliary interventions and abscess drainage. The workshop programme involved lectures, small group teaching and hands-on device training. In addition, there were several live cases performed by the faculty, including myself. Live case topics included TACE, RFA, lower limb arterial angioplasty and stenting, and haemodialysis access angioplasty and stenting. One less obvious benefit of in-person training was that local IRs strongly encouraged clinicians from other specialties to attend the workshop, particularly specific lectures and live cases that were relevant to their practice. This meant that during each lecture or tutorial, aspects of procedures were highlighted to increase the attractiveness of interventional radiology to these referring clinicians with specific emphasis put on the favourable comparison of interventional radiology procedures with the competing alternative treatments. The desired result of such an interaction would be to increase the number of referrals to interventional radiology by these local clinicians, which in my opinion, was an effective method—and one that is less translatable to an online educational format. In summary, the main benefits of outreach training included: enabling local IRs without the financial resources to attend in-person congresses to receive a programme of tailored education to their

Although quality education can be delivered remotely, in-person training such as can be provided by outreach training enables valuable interactions and discussions between training faculty and trainees that are difficult to replicate online.” departments are well equipped with two or more computed tomography (CT) scanners, at least one magnetic resonance imaging (MRI) scanner, one angiographic machine and general radiographic equipment. The vast majority of the interventional radiology staff at these hospitals had never had the opportunity to attend a major congress, such as APSCVIR, CIRSE or SIR. All visiting international faculty members were impressed by the enthusiasm of the local staff and trainees to learn about interventional radiology. It was very evident that they were highly appreciative of receiving training from the visiting faculty. A comprehensive scientific programme

specific requirements and surroundings; and raising the awareness of the potential of interventional radiology among other clinical specialties, which may result in increased referrals of patients for these minimally invasive, typically outpatient procedures.

Where are we now?

Inevitably, as a result of the effect of the COVID-19 pandemic worldwide and the severe restrictions on international travel, these outreach training programmes have come to a halt. In a similar manner to international congresses, which have currently moved almost exclusively to an online/virtual format, some societies have endeavoured to provide outreach

training online through webinars and live discussion forums. This method of education has similar drawbacks for the delivery of outreach educational workshops as it does for international meetings. These are relatively obvious but are worth stating nevertheless: reduced impact of online lectures compared with live lectures; a lack of interpersonal interactions for educational and networking purposes; reduced opportunity for small group discussions; and the complete absence of hands-on device or procedural training. Finally, a specific disadvantage of online teaching for less well-developed countries is the dependence on the local information technology (IT) structures and ability of the local IRs and trainees to access the internet adequately for online teaching, which may be demanding in terms of the bandwidth required.

Where do we go from here?

The experiences of the past 18 months have reminded us that the internet is an effective method to deliver education and training. However, the majority of doctors, both trainees and trainers, are firmly of the opinion that virtual methods do not, and must not, completely replace in-person educational methods. However, the pandemic is a worldwide phenomenon. Although vaccination programmes in many countries, particularly in Europe and North America are well advanced, this is not the case in Asia, South America or Africa where a significant proportion of outreach programmes take place. It is likely that international congresses will return as live educational events in 2022, but they will be restricted by COVID-19 testing and impacted by the country of origin of delegates. Unfortunately, it may be longer before IRs are able to travel to countries with lower vaccination rates to deliver outreach training. However, this is not to say that this form of training must be abandoned or forgotten. International societies such as CIRSE, SIR, and APSCVIR must continue to commit to the concept of outreach training and to make plans for the day when this valuable training format once again becomes feasible to deliver. In summary, international societies have the ability and an obligation to deliver local education and training to IRs in lower- and middle-income countries. Local in-person outreach training has significant benefits that cannot be provided by the virtual format. Although a return to outreach training workshops may not be feasible for a year or more, this important method of training must not be forgotten and interventional radiology societies must continue to devise schedules for outreach training as soon as this becomes possible again. Robert Morgan is a consultant and reader in interventional and diagnostic radiology. He is deputy editor-in-chief CVIR Endovascular and a past president of CIRSE. He has reported no disclosures relevant to this article.

Issue 83 | September 2021

Remote Training

Photo 45627168 / Medical © Everythingpossible | Dreamstime.com

John Rundback

Remote stroke interventions raise several unique ethical challenges At the Society of NeuroInterventional Surgery’s 18th annual meeting (SNIS; 26–29 July 2021, Colorado Springs, USA and virtual), Jeffrey Saver, professor of Neurology at the University of California, Los Angeles (UCLA) Medical Center and director of the UCLA Stroke Center (Los Angeles, USA), discussed the various ethical considerations that need to be taken into account regarding robotic applications in neuroendovascular interventions, and remote stroke care, stating that “we all need to work together to make sure patients have the best outcome”.

DURING A SESSION THAT Saver outlined was “compromised also saw multiple presentations informed consent” on the patient’s part. demonstrating the potential benefits and He emphasised the criticality of full new possibilities enabled by these novel disclosure of the fact many of these technologies, Saver claimed procedures are fairly new, this is an area that brings and, as such, there is limited up “several unique domains evidence on both their benefits of challenging bioethics”— and their risks. “There is a including the ethics of remote general tendency for patients to care, the ethics of introducing equate newness with increased new surgical techniques and benefit—and we have to Jeffrey Saver training protocols, the ethics counter this tendency when we of robot-assisted procedures, and even talk with them,” he added. Saver also autonomous, artificial intelligence (AI)noted that, while trust in the authority powered robotic systems, which are of the interventionist performing the currently physician-supervised but may given procedure should be encouraged, be unsupervised in the future. The first specific ethical consideration Continued on page 8

September 2021 | Issue 83

New Horizons

Continued from page 7

“humility”—to reflect their oftenlimited experience in performing these procedures compared to more traditional surgeries—is important here too. Saver went on to state that various conflicts of interest on the physician’s side are significant too, and should be fully disclosed to the patient, with these ranging from direct financial benefits and other incentives, and brand loyalty, to the “elevated social status” of being a surgical innovator and bias towards performing a technique in which training has been invested—referring to the phenomenon of “sunk cost” here as well. He noted that harm to the patient, including increased morbidity and mortality, is the “most important” ethical consideration that may be associated

with robotic or remote procedures. “We need stringent QI [quality inspection] and reviews of every case,” Saver added. He went on to state that research burdens should not be placed disproportionately on disadvantaged or poorer communities, despite the fact that patients from these backgrounds may only gain access to advanced care by participating in innovative therapy systems—something he described as a “challenging ethical issue”—and added that these expensive technologies should not take too many resources away from proven care approaches either. Another factor that Saver claimed is especially pertinent to remote intervention is the notion of a “diminished physicianpatient relationship”, whereby the patient has reduced access to the interventionist. “We need to be sure that the interventionist

Five-year ACST2 results: Carotid artery surgery and stenting have similar long-term effects on stroke

maximises their availability to the patient—not just during the case, but by telemedicine pre and post if they are doing a case remotely,” he stated. Saver also noted that there could be a risk for decreased empathy on the part of the physician for patients and families with whom they have never had direct contact. On a similar note, he alluded to the “diffusion of responsibility” that may be seen to be associated with these novel surgeries, referring to a “broader network of interdependent care” than is common in medicine. This network involves the remote interventionist, local physicians and nurses, hardware manufacturers, software coders, the AI system being deployed, and more. “We need to make sure we have an active, continuous partnership,” Saver also said. As well as giving a nod to the

more distant future in this ever-evolving space within neurosurgery—that being the ethics of fully autonomous, robotic interventionists—Saver chose to end his presentation on a more positive note. Firstly, he encouraged the attending audience to consider the future of their own patients, but also future generations of patients who, further down the line, stand to benefit from many of the innovations currently being advanced, adding that “a procedural speciality does require a little bit of risk taking”. Saver concluded his talk by addressing the need to consider the wellbeing of the physicians themselves in this debate— noting that the minimised radiation exposure and reduced lead-wearing risks that neurointerventionists may gain via robotic or remote surgical techniques are “a very important ethical goal” as well.

with carotid procedures used to be “substantial”, the sufficient stenosis to justify intervention); the doctor authors communicate, they have become lower over and patient agreed that a carotid procedure should the years. In fact, they reference nationwide registry be undertaken, but they were substantially uncertain data from Germany showing that, among asymptomatic whether this should be CAS or CEA; and the patient had patients, CAS and CEA are both associated with a risk no known circumstance or condition likely to preclude of approximately 1% of disabling stroke or death. long-term follow-up.” Comparative data are lacking on the long-term Reasons for exclusion included previous ipsilateral protective effects of the two carotid procedures. intervention, unsuitability for CAS (e.g. due to Halliday et al summarise the available data: “The calcification or tortuosity) or CEA, high procedural risk evidence thus far from randomised trials of CAS (e.g. because of recent acute myocardial infarction), versus CEA suggests appropriate similarity of the high risk of cardiac emboli, or any major lifelong-term protective effects of the two procedures, but threatening condition. Patients likely to require other it has involved only limited numbers of asymptomatic surgery could not enter the trial until at least one month patients.” The ACST-2 trial, with a larger number of after the trial’s ompletion. Carotid artery surgery and stenting have participants, aimed to provide more robust comparisons Regarding procedural risks, 1% of patients in both comparable long-term effects on fatal or of the long-term protective effects of CAS versus CEA. groups had a disabling stroke or died within 30 days (15 disabling stroke in asymptomatic patients ACST-2 (the second asymptomatic carotid surgery allocated to CAS and 18 to CEA) and 2% had a nonwith severe carotid artery stenosis, latetrial) is the largest study to date comparing the long-term disabling procedural stroke (48 allocated to CAS and 29 breaking ACST-2 data presented in a Hot effect of CAS versus CEA on stroke in asymptomatic to CEA). Line session at the European Society patients with a severely narrowed carotid artery that The main outcome was five-year non-procedural of Cardiology’s 2021 congress (ESC had not yet caused a stroke. However, Halliday et al see stroke; fatal or disabling stroke occurred in 2.5% of 2021; 27–30 August, virtual) and published the study size as the chief limitation of the trial. They patients in each group, for a rate ratio (RR) of CAS simultaneously in The Lancet revealed. elaborate: “This is the largest carotid intervention trial versus CEA of 0.98 (95% confidence interval [CI] 0.64– yet conducted, but still it must be considered together 1.48; p=0.91), and any non-procedural stroke occurred atients with severe carotid artery stenosis are at with all other trials of CAS versus CEA.” in 5.3% of the CAS group versus 4.5% of the CEA elevated risk of stroke, and both carotid artery The international, multicentre, randomised group (RR 1.16; 95% CI 0.86–1.57; p=0.33). A stenting (CAS) and carotid endarterectomy ACST-2 trial enrolled patients with severe meta-analysis of this and all other major trials (CEA) can restore patency and reduce the longcarotid artery narrowing found by of CAS versus CEA yielded a similarly nonterm risk of stroke. chance, but with no recent stroke significant result for any stroke (RR 1.11; “ACST-2 is the world’s largest randomised or other neurological symptoms. 95% CI 0.91–1.32; p=0.21). trial of carotid procedures to date, Participants were thought by Halliday concluded at ESC: “We have representing the work of many surgeons, their doctor to need CAS or shown that, for patients with a severely radiologists and stroke doctors,” principal CEA but both doctor and patient narrowed carotid artery, stenting and surgery investigator Alison Halliday (University of were substantially uncertain about have similar effects on the chances of having Alison Halliday Oxford, Oxford, UK) tells Interventional which procedure was preferable. a disabling or fatal stroke. The risk from each News. “The follow-up will continue Between 15 January 2008 and 31 procedure is about 1%. After that, however, the annual until 2026, when the final results will be December 2020, a total of 3,625 patients risk over the next five or more years is halved, from 1% The risk from reported.” were enrolled from 130 centres in 33 down to 0.5% per year.” each procedure Writing in The Lancet, Halliday and countries. Participants were randomly is about 1%. colleagues detail that, in North America, allocated 1:1 to CAS or CEA and followed Research in context After that, some 100,000 surgery or stenting up for an average of five years. The main “ACST-2 has randomly allocated 3,625 asymptomatic however, the procedures are done each year to treat outcomes were procedural risks (morbidity patients with severe carotid stenosis to CAS or CEA annual risk over carotid artery narrowing, and numbers and mortality within one month after the with good compliance and, thus far, a mean of five the next five or are similar for Europe. About half are to procedure) and, most importantly, nonyears of follow-up,” the authors summarise. Putting more years is prevent recurrent stroke in symptomatic procedural stroke, subdivided by severity. this into context, they stress that the trial has more than halved, from 1% patients and half are for primary stroke The authors expand on the inclusion doubled the number of asymptomatic patients in trials down to 0.5% per year prevention in asymptomatic patients, with criteria for the study: “Patients were eligible of CAS versus CEA. However, they acknowledge that the proportion varying from one country if they had severe unilateral or bilateral the randomised evidence from both asymptomatic and to another. “Successful CEA approximately carotid artery stenosis (generally 60% or symptomatic patients is relevant to any comparison halves the long-term risk among asymptomatic higher on ultrasound); this had not caused any between the two procedures. “With ACST-2 included, patients with severe (e.g. 70–99%) stenosis,” the relevant neurological symptoms in the preceding there is now as much evidence among asymptomatic authors note. six months; there was computed tomography (CT) or patients, and the findings in both types of patients are However, both CAS and CEA carry a short-term risk magnetic resonance imaging (MRI) confirmation of remarkably similar, with CAS about as effective as CEA of stroke, which is about twice as great for symptomatic suitability for CAS and for CEA (which would also have at reducing the annual risk of stroke, at least for the first as for asymptomatic patients. While the risks associated been used to exclude from trial entry any patient without few years,” they conclude.

September 2021 | Issue 83

10 Shifting Landscape

SIR to CMS: Protect access to patient care, reverse devastating Medicare Physician Fee Schedule cuts Proposed cuts to physician reimbursements could shutter practices and leave thousands of medically vulnerable patients without access to care, the Society of Interventional Radiology (SIR) said in a comment letter submitted to Centers for Medicare and Medicaid Services (CMS) in September. THE LETTER WAS SUBMITTED IN RESPONSE to the July 13 proposed rule for the 2022 Medicare Physician Fee Schedule (MPFS). Under the proposal, interventional radiologists (IRs) could see an aggregate cut of 13% for all interventional radiology treatments, with certain procedures performed in office-based lab settings experiencing cuts greater than 20%. Treatments with the highest cuts include limb-saving peripheral arterial disease treatments, clot-busting venous treatments, venous stenting and other vascular work. “The rule represents a perfect storm resulting from CMS’s decision to allow their labour rates and product cost tables to lag behind inflation,” said SIR President Matthew S Johnson, an IR and Gary J Becker Professor of Radiology Research at Indiana University School of Medicine, USA. “In many cases, practice costs have not been updated in 20 years. Due to purported budget neutrality, CMS made apparently arbitrary cuts rather than reimburse all practices and specialties at their true cost of care.” While CMS considers such cuts “budget neutral” they disproportionately affect procedures performed by IRs in office-based settings, such as treatment of venous ulcers and dialysis access. More importantly, the services most affected treat diseases that disproportionately affect patients of colour, such as peripheral artery disease, venous disease, renal disease and cancer. “As a result, the profound cuts will negatively affect health equity in communities who have already been particularly hard hit by the COVID-19 pandemic,” said Johnson. “By making it difficult for outpatient, officebased labs to continue to operate, patients seeking care will have to do so in hospital settings, which are still

reeling from COVID-19. For some patients, this could mean traveling hours outside of their community to receive treatment.” Throughout the pandemic, office-based facilities have allowed hospitals to focus on the sickest COVID-19 patients while allowing lifesaving cancer treatments and limb-saving vascular procedures to continue. The cuts may make some practices unsustainable, directly impacting readiness for future COVID-19 surges or new pandemics. In addition, officebased lab facilities deliver quality care to patients far from major hospital centres. Community-based, outpatient care allows patients to return to their normal lives sooner. “We must protect patients’ access to that crucial care and prevent private practices from closing down, especially in underserved areas,” said Johnson. SIR is joining with other healthcare organisations, such as the American Medical Association (AMA), the American College of Radiology (ACR), the CardioVascular Coalition (CVC) and other medical for all specialty societies, to interventional combat these cuts and radiology plead with CMS and treatments, Congress to: ■ Reverse the cuts. ■ Suspend sequestration.

An impressive launch for the first IR Juniors Global Summit

The idea of this summit was suggested by the newly formed Residents, Fellows, and Students (RFS) committee in the Pan Arab Interventional Radiology Society (PAIRS), matching with the general theme of the PAIRS “Investing in Youth” write Gregory Makris (London, UK) and Rana Khafagy (Cairo, Egypt).

Gregory Makris Rana Khafagy Comment & Analysis

Maintain for 2022 the COVID-19 related increase to the conversion factor to ensure that what is reimbursed better reflects the real cost of healthcare in a pandemic world. ■ Avoid implementing clinical labour pricing revisions at this time. If they must implement it, phase the new rates in over four years to minimise the effects on private practices. ■ Adopt unique, multispecialty with committee (AMA/ certain procedures Specialty Society performed in officebased lab settings RVS Update experiencing cuts Committee [RUC]) greater than reimbursement recommendations for specialty and practice expense codes. ■

Under the proposal, interventional radiologists could see an aggregate cut of

13%

INTERVENTIONAL RADIOLOGY (IR) has been growing at an impressive pace during the last few decades. From a relatively unknown specialty it has become one of the most dynamic and competitive specialties to get into. The specialty has been steadily attracting a different kind of trainee than the traditional radiology programmes. More trainees with a surgical background or mindset have been joining or want to join the specialty and the international community of young and ambitious interventional radiologists-in-training has exploded with many national and international junior committees having been formed and playing an active role in forming the future landscape of IR. With such a rapidly evolving and expanding specialty, the necessity to include the fresh minds of young interventional radiologists into the game became essential. The start was made by the two biggest IR conferences in the world; the annual Cardiovascular

20%

and Interventional Radiological Society of Europe (CIRSE) and Society of Interventional Radiology (SIR) conferences have been offering, for a few years now, dedicated junior and student sessions within their main programmes so far with great success. We thought it was about time to move to the next step and have a conference, dedicated to the junior IR community. The idea of this summit was suggested by the newly formed Residents, Fellows, and Students (RFS) committee in the Pan Arab Interventional Radiology Society (PAIRS), matching with the general theme of the PAIRS “Investing in Youth”. This initiative was welcomed by several international IR junior committees who all agreed to organise the summit in collaboration with each other recruiting as many societies as possible from around the globe. The summit was co-organised by the junior sections of CIRSE, SIR the British

Issue 83 | September 2021

Cost Analysis 11

Cost utility analysis of the FEMME trial reports uterine artery embolization as not cost-effective over myomectomy Dikshyanta Rana Comment & Analysis

ikshyanta Rana of the Institute of Health and Wellbeing at the University of Glasgow (Glasgow, UK) discusses the key findings of an economic evaluation of the FEMME randomised controlled trial (RCT), and an accompanying mini commentary, which were published in the BJOG: An International Journal of Obstetrics & Gynaecology recently. The economic evaluation included a cost-utility analysis (CUA) which compared uterine artery embolization (UAE) and myomectomy for women with symptomatic uterine fibroids wishing to avoid hysterectomy. CUA is a form of economic evaluation which allows estimation of cost per preference-based valuation of outcome. The CUA was performed from the perspective of the UK National Health Service (NHS) at two-year and four-year follow up. It included 254 women who were randomised to UAE (n=127) and myomectomy (n=127). Direct medical costs were estimated. QALYs, which is a summary measure that quantifies the quality

and quantity of life-years gained from a treatment, were used to express the healthrelated quality of life (HR-QOL) outcome. It was calculated using the utility score obtained from a preference-based quality of life instrument, EuroQoL 5D 3L. The results indicate UAE as not a cost-effective alternative to displace myomectomy. We observed that UAE patients had higher costs and lower QALYs compared to myomectomy patients. Our analysis also showed that at a willingness-to-pay (WTP) threshold of £20,000, myomectomy had a 98% and 96% probability of being cost-effective at two-and four-years follow-up. In the UK, the National Institute for Health and Care Excellence (NICE) has specified a maximum WTP threshold of £20,000– 30,000 per QALY. Any treatment which is over this threshold is judged as not cost-effective and therefore, not recommended for adoption by the NHS. Initially, treatment costs were lower for UAE patients as the procedure itself is cheaper and requires a shorter stay in

Society of Interventional Radiology (BSIR) and the IR Juniors in the UK. This collaborative one-day summit was held virtually on 17 July 2021 and was hosted by the PAIRS platform. The programme involved some toptier panelists and eminent speakers from around the globe including Europe (UK, Slovakia, Italy, France, and Spain), the USA, Middle East, Canada, Australia, Japan, China, India, and Tanzania. Topics of the meeting were tailored to help the target audience to know more about the specialty and how to start their career mainly highlighting the IR training status and the training opportunities worldwide along with introducing the PAIRS RFS, CIRSE European Training Forum (ETF), the SIR RFS, and other junior committees in different countries in Europe, China, and Japan. This session was followed by two inspiring talks about women in IR then a keynote lecture titled “Clinical comprehensive care: Lifelong

longitudinal vascular and interventional radiology”. The final sessions were mainly attributed to current IR juniororiented projects across the globe with the announcement of the inaugural International IR Junior games, powered by PAIRS. The summit statistics were quite impressive making the inaugural IR junior summit a success. Streaming to 61 different countries from six continents with 627 attendees including juniors, students, and diagnostic radiologists. The top six countries in terms of attendance figures were Egypt, Saudi Arabia, the USA, UK, India, and United Arabic Emirates, respectively.

the hospital for recovery compared to myomectomy. However, UAE patients started accumulating higher costs after discharge. The reason behind this was an increased utilisation of healthcare resources in the form of general practitioner (GP) visits, outpatient appointments and inpatient admissions during the follow-up period. The increase was also associated with reinterventions for fibroid removal. With regard to QALYs, both treatments led to an improvement in the quality of life of women. A closer look at the EQ5D domains showed that women who underwent myomectomy experienced a greater improvement in terms of pain/ discomfort and anxiety/depression. The study emphasises that the differences in costs and QALY between the two procedures were small and statistically insignificant. The cost difference over two years and four years was £645 and £352, respectively. QALY difference was -0.09 for both years. Converting the QALY difference between the two treatments to days in perfect health shows that myomectomy added only 33 days on average, compared to UAE. Interestingly, it is difficult to establish if 33 days creates a meaningful difference in women’s lives or not. Though QALYs are a valid and reliable measure for expressing health outcomes, they may not always be sufficiently sensitive to capture non-health related preferences of individual patients for various treatment processes. Thus, the CUA framework is restrictive here. Our trial design did try to capture women’s preferences for non-health outcomes by asking questions like ‘would you have your operation again?’ and ‘would you recommend the operation to a friend?’ to women at various follow-up time points. The results were favourable to both treatments, although myomectomy was viewed more favourably. Nevertheless, an inclusion of more formal quantitative methods for eliciting patient preferences, such as a discrete choice experiment (DCE) would have added value.

The post-summit feedback was also very positive with 98.9% respondents reporting that this summit had fulfilled their expectations. IR Juniors Global Summit 2021 was just the beginning—a small step in a series of global projects dedicated to our juniors in the field and the future of our specialty. We hope that this summit can promote even further the bonds between the various national and international junior committees helping them to learn from each other and create these vital networks that can allow our specialty to continue growing by attracting the best possible talent. Hopefully, the future

With such a rapidly evolving [...] specialty, it is necessary to include fresh minds of young interventional radiologists into the game.”

The comparison of non-invasive, nonsurgical treatment UAE and invasive, surgical treatment myomectomy for women with symptomatic uterine fibroids is long overdue. There are few existing RCTs which compare both treatments, however, they have small samples and together provide inconclusive results. Our trial has overcome this hurdle of recruitment and successfully achieved its aims. Relatedly, the current economic literature includes studies based on inconclusive clinical evidence and do not directly compare UAE and myomectomy. We hope that our economic evaluation will fill this gap by using robust data obtained from the largest, multicentre trial of its kind.

It is crucial that the preferences of well-informed patients are considered when choosing between UAE and myomectomy. ” Above all, we must remember that symptomatic uterine fibroids are a genuine issue for women of reproductive age as it impacts their quality of life. Therefore, it is crucial that the preferences of well-informed patients are considered when choosing between UAE and myomectomy. All women should have the option to choose between the two procedures.

Dikshyanta Rana is a research assistant at the Institute of Health and Wellbeing at the University of Glasgow, Glasgow, UK.

summits will be even better attended, with more global participation outside Europe and the USA. Having this summit on an annual basis in a physical or a hybrid form is our next goal and we hope to make this event the primary event for all doctors who are thinking of doing IR or are in the IR training process. None of this would have happened without the amazing support of the executive committees of CIRSE, PAIRS, SIR and BSIR. Gregory Makris is a consultant in Endovascular Therapies and Interventional Radiology at King’s Health Partners, London, UK. He is the past chair of the CIRSE ETF. Rana Khafagy is an interventional radiology consultant at Ain Shams University Hospitals, Cairo, Egypt. She is also the head of the PAIRS Residents Fellows and Students (RFS) committee.)

September 2021 | Issue 83

12 Novel Devices

EShunt system offers promise for endovascular treatment of hydrocephalus “I have tried several devices in the last 10 or 20 years, but I think this is absolutely different—this is the first time that we have treated non-vascular problems [using an] endovascular solution,” Pedro Lylyk (Clinica Sagrada Familia, Buenos Aires, Argentina) told attendees at the Society of NeuroInterventional Surgery’s 18th annual meeting (SNIS; 26–29 July 2021, Colorado Springs, USA and virtual), documenting first-in-human experience with the eShunt system (CereVasc)—an investigational device for the treatment of communicating hydrocephalus (CH).

ylyk is the principal investigator in the ETCHES I (Endovascular treatment of communicating hydrocephalus with the eShunt system) trial assessing the use of the device, which is implanted through a leg vein using X-ray guidance. EShunt is described as the first minimally invasive treatment for CH—the abnormal build-up of fluid in the brain. The current standard of care for CH is the ventriculoperitoneal (VP) shunt, Lylyk told SNIS attendees during the late-breaking abstract session in which he presented the results of the first-in-human case. VP shunts have been shown to have high complication and failure rates, Lylyk added, with reports describing that >40% of VP shunts fail within the first two years of implantation. Therefore, Lylyk and colleagues believed that, using modern fluoroscopic imaging and 3D vascular visualisation, a less-invasive option may be viable. EShunt is designed to eliminate the need for a craniotomy or surgical opening into the skull, passage of a catheter through white matter of the brain, or subcutaneous tunnelling across the chest and abdomen for placement of a long outflow catheter into a second surgical incision in the abdomen. The shunt consists of a subarachnoid space (SAS) anchor, a shunt body of 35mm in length, and a slit proximal valve, Lylyk described in his presentation,

noting that the delivery system is comprised of two components: one distal, that stays at the cavernous sinus; and one proximal, which is a 4Fr penetrating catheter with a 20G needle, protected by a retractable needle guard. Describing the case, Lylyk told SNIS attendees that the patient, an 84-year-old female, was referred five days after subarachnoid haemorrhage (SAH) and developed neurological deterioration after a further five days. CH was detected on computed tomography (CT), prompting the implantation of the eShunt. The patient died 59 days after occurrence of the SAH after developing sepsis secondary to a respiratory infection progressing to renal failure, but Lylyk described early experience with the device as encouraging. “We achieved the early communication between the CSF [cerebrospinal fluid] and the blood,” Lylyk told Interventional News in an interview following his SNIS presentation, in which he discussed the procedure. “We dropped the pressure inside the brain [which returned] within the next 36 hours up to normal, so that was a big achievement. The patient had improved ICP [increased

Brain-computer interface technology opens up “whole new world” of therapies

“We are starting to help patients in ways that we did not think were possible,” Thomas Oxley (Mount Sinai Hospital, New York, USA) tells Interventional News, referring to the potential of brain-computer interface (BCI) technology. Alongside his role as a vascular and interventional neurologist, Oxley is chief executive officer of Synchron, developer of the Stentrode motor neuroprosthesis. The Stentrode is an implantable BCI device that, according to Oxley, is the first of its kind to be in the early feasibility clinical stage in the USA following US Food and Drug Administration (FDA) approval of Synchron’s investigational device exemption (IDE) application last month. Following a presentation on the topic at the Society of NeuroInterventional Surgery’s 18th annual meeting (SNIS; 26–29 July 2021, Colorado Springs, USA and virtual), Oxley gives an overview of the COMMAND early feasibility study, anticipates key results, and considers more generally how BCI technology could shape the future of deep brain stimulation.

“THE GOAL OF WHAT WE ARE doing is to get to a pivotal trial,” Oxley states, detailing that the Stentrode is a Class III device and so needs premarket approval (PMA) from the FDA. In order to begin a pivotal study, it is first necessary to go through a feasibility study. “I believe we are the only company with an implantable BCI in the early feasibility clinical stage in the USA,” he informs Interventional News. “We are collecting data on the safety and efficacy that will enable us to shape the

pivotal trial to come in the next couple of years in order to head towards approval and then get the technology out to the market.”

“The biggest challenge”: Quantifying a new metric

The aim of the feasibility study is twofold, Oxley communicates. “On the safety side, we are first and foremost demonstrating that it is safe to leave a stent electrode inside a venous system and inside the brain,” with thrombosis

intracranial pressure] of the brain, so that was the first achievement.” However, Lylyk also commented that the proof of the concept also potentially opens the door for its wider usage. “This is a fantastic new solution for [treating] non-vascular problems by endovascular means,” he said. “This is the first case in which we achieved the percutaneous endovascular transluminal access to the central nervous system and that may have nice implications for an access platform. “We can deliver gene therapy, brain stem cells, or do endovascular surgery that way. Also, we achieved the first transdural venous to cisternal punctures safely, without any haemorrhage inside the brain,” he noted. “I think we have proved the concept that we can join the CP [cerebellopontine] angle, the cistern of the CP angle, with the IPS [inferior petrosal sinus] with rapid and sustained decreases of ICP.” Lylyk added that he is “very excited” about the potential of the device. “I think this is a new avenue for us for the endovascular treatment Pedro of many other diseases. It is just the first Lylyk step, but I think it is a big step,” he told Interventional News.

I think this is a new avenue for us for the endovascular treatment of many other diseases. It is just the first step, but I think it is a big step.” Pedro Lylyk

and stroke being the two key events to watch out for. “We have had neither of those events so far,” he says. “On the efficacy side, the question is how to quantify the utility of a BCI, or a motor neuroprosthesis,” Oxley relays. “The biggest challenge of the feasibility study is to identify the performance metric to quantify the effectiveness of the motor neuroprosthesis in the study to come.” In order to assess the aims of the COMMAND study, researchers will be recording shifts in frequency when patients attempt to move their arms or legs, translating these shifts into outputs that become digitised. These digitised outputs, Oxley explains, will then be used to control technology platforms like Google, Microsoft, and Amazon, to enable patients who are paralysed to region control over those systems. Oxley specifies that the team is focusing initially on paralysis and then epilepsy, but that ultimately “all deep brain stimulation targets should be accessible”.

“We can access all regions of the brain”: Expanding neurointervention horizons

“The most exciting aspect of the emergence of neurointerventional electrophysiology is that we can access all regions of brain,” Oxley remarks, adding that once the technology is small enough and safe enough, he sees a future where the neurointerventionists are

Thomas Oxley

placing multiple devices inside the brain. In addition, Oxley predicts a change in who will deliver such a treatment, seeing in the future a neurointerventional electrophysiology room and not just a typical neurointervention suite. Concluding, Oxley believes that the development of BCI technology and the “incredible amount of information” it will provide should help to address unanswered questions across many areas—from epilepsy and movement disorders to depression and sleep. “I think there is going to be a whole new world opened up of therapies that have only been in the domain of the craniotomy, but now we can bring that into a minimally invasive approach. We are starting to help patients in ways that we did not think were possible.”

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September 2021 | Issue 83

14 Ablation Advances

SIR publishes new position statement and quality improvement document on percutaneous lung ablation The Society of Interventional Radiology (SIR) has issued a new position statement on percutaneous lung ablation in the August edition of the Journal of Vascular and Interventional Radiology (JVIR), along with an accompanying quality improvement document, which establishes performance thresholds for patient safety. MARK BAERLOCHER, SIR’S STANDARDS image-guided thermal ablation to treat these tumours. division councillor and an author of the position The method of ablation should be determined by lesion statement and quality improvement document, said: characteristics and risk mitigation, according to the new “Minimally invasive, image-guided thermal ablation document. offers patients with early stage, non-small-cell lung SIR president, Matthew Johnson, said: “Evidencecancer, recurring lung cancer, and metastatic disease a based position statements are important means of safe and effective treatment option. improving patient outcomes. Future comparative “The two publications provide physicians with studies on the use of thermal ablation to treat guidance on everything from patient selection these forms of lung cancer will help improve to treatment delivery and post-treatment care the evidence base and allow us to make and follow-up, ensuring high-quality care that stronger recommendations to the benefit improves patients’ lives,” added Baerlocher, of patients.” an interventional radiologist at the Royal The position statement was developed Victoria Hospital in Ontario, Canada. by a multidisciplinary group of authors Lung cancer is the second most common Matthew Johnson including interventional radiology, newly diagnosed cancer in the USA, with medical oncology, thoracic surgery and an estimated 228,000 new cases diagnosed in 2020. It is radiation oncology specialists. It is endorsed by the also the leading cause of cancer-related death. Canadian Association for Interventional Radiology, the Interventional radiologists use image-guided thermal Cardiovascular and Interventional Radiological Society ablation to treat primary and secondary lung tumours. of Europe and the Society of Interventional Oncology. Based on the current evidence, the position statement recommends that radiofrequency ablation, cryoablation Read the full position statement and quality and microwave ablation are all appropriate forms of improvement document on jvir.org

Why histotripsy may be the next leap forward in ablative therapy Histotripsy, which was invented at the University of Michigan (Ann Arbor, USA), uses pulsed sound waves to destroy tissue. It is a non-invasive and non-thermal mechanism that is currently being studied for its “completely different mechanism for ablating tissue, which […] we hope to leverage to our advantage in treating cancer,” says Fred T Lee Jr, a professor (tenure) of Radiology, Biomedical Engineering and Urology, the Robert A Turrell professor of Imaging Science, and the chief of Abdominal Intervention at the University of Wisconsin (Madison, USA). In an interview with Interventional News, Lee asserts that histotripsy could overcome some of the limitations of thermal ablation. MORE EVIDENCE IS NEEDED and there is a “still a lot of work to be done,” he cautions, while suggesting that, in the future, histotripsy could be used as an immune primer in conjunction with checkpoint inhibitors. It might, therefore, be useful in treating patients with very advanced tumours or multiple tumours that “we ordinarily would not be able to treat with ablation,” he says.

Thermal ablation: Strengths and weaknesses

While thermal ablations “work pretty well” and have few limitations, Lee remarks that the interventional radiology community has “reached somewhat of a plateau” in the development of this technique. Lee elaborates on two of the biggest drawbacks that specialists are trying

to overcome with some of the newer thermal ablation technologies in development, namely complications linked to the puncture and a lack of temperature control. “One of the main limitations of thermal ablations has to do with the percutaneous approach,” he tells this newspaper, adding that many of the complications associated with thermal ablations relate to the puncture needed to insert a needle into the tumour. He comments: “It would be ideal to eliminate the need to place a needle into the tumour.” Another limitation Lee mentions is the lack of control interventional radiologists have over the temperature of thermal ablation modalities, which intrinsically use heat or cold to destroy tissue. “Once we apply radical temperatures inside the human body,

Evidence-based position statements are important means of improving patient outcomes. Future comparative studies on the use of thermal ablation to treat these forms of lung cancer will help improve the evidence base and allow us to make stronger recommendations to the benefit of patients.”

we are at the mercy of physics,” he says. “The temperatures that we apply at the needle are either very hot or very cold, and as you radiate out from the needle you start losing the extreme temperatures. That is something that is ruled by physics, not by the applicator itself, and is a major limitation over which we have minimal control after we power the needle to cause heating or cooling.”

The workings of histotripsy

Lee explains that histotripsy is focused ultrasound that is applied in very high amplitude pulses. He details that these pulses are at a low-duty cycle, meaning that the pulse is on for only a very short period of time and then the remainder of the time it is off. “The duty cycle is 1% or less with histotripsy, and this allows us to get away from heating the tissue.” He elaborates on how the technique ablates tissue: “At the focal zone, cavitation occurs, which is basically when bubbles are pulled out of the tissue by very high negative pressures, and these bubbles rapidly expand and collapse. This process causes tremendous stress and strain on the tissues in which the bubbles are being formed, and the high pressures that are formed in the tissue, combined with the high stress and strain from the creation and destruction of these bubbles eventually causes tissue breakdown. That mechanical force is what we use to destroy tissue with histotripsy.” “This is a completely different way of

destroying tissue than what we are used to,” Lee tells Interventional News. “It is not thermal and it is not radiation. It is a completely different mechanism of ablating tissue and therefore it has some very interesting properties that, if we are fortunate, we will be able to leverage to our advantage in treating cancer.”

Histotripsy: An immune primer?

Lee points out that histotripsy has multiple potential benefits in the arena of ablative therapy. “It turns out that histotripsy not only releases neoantigens that allow the body to recognise some of the tumour cells that are in the liver or the kidney, or whatever target you are focusing on, but it also works well with some of the checkpoint inhibitors and other immune strategies that are being developed around the world,” he states. Lee highlights the fact that the technique has been looked at primarily in animal models so far and that “there is still a lot of work to be done,” but stresses that histotripsy shows promise. “As I look into the future,” he ponders, “I wonder if histotripsy will be able to be used in patients with very advanced tumours or multiple tumours that we ordinarily would not be able to treat with ablation.” “It seems that it may be possible to use histotripsy as an immune primer or some sort of adjunct with other therapies, which will allow our community to be important in treating patients with more advanced tumours than we currently do today.”

Issue 83 | September 2021

Ablation Advances 15

Cast the die for randomised evidence comparing percutaneous ablation with surgery and prepare for the flood of renal cell carcinoma patients

Christopher S Morris Comment & Analysis Despite the well-known obstacles, it is time for a prospective, randomised clinical trial comparing percutaneous ablation (PA) and partial nephrectomy for the treatment of small renal cell carcinomas— and re-thinking the common practice of watching and waiting, rather than intervening, is long overdue, writes Christopher S Morris (Larner College of Medicine, University of Vermont, Burlington, USA).

urrent studies with a moderate level of evidence have already confirmed decreased complications and similar effectiveness of PA compared to surgery in treating small renal tumours. Interventional radiologists (IRs) everywhere should be prepared for an increasing influx of patients seeking treatment of their small renal cell carcinomas with PA. In developed countries, the incidence of renal cell carcinoma has increased over the past 20 years, mainly due to the increase in cross-sectional imaging and improving life expectancies. More than 50% of these tumours are diagnosed incidentally. In 2021, it is estimated that there will be more than 76,000 new kidney cancers diagnosed and almost 14,000 deaths attributed to kidney cancer in the USA alone. Like many solid malignancies, renal cell carcinoma is most effectively treated while small and prior to local and regional invasion, and certainly before the progression to distant metastatic disease. Although the standard treatment of renal cell carcinoma is nephrectomy and partial nephrectomy, IRs have been treating small T1a (<4cm) renal cell carcinomas with PA, either cryoablation, radiofrequency ablation (RFA), or microwave ablation (MWA) for more than 20 years. Despite the proven safety and efficacy of PA for small renal tumors, less than 10% of these lesions are treated with PA. In addition, studies

have shown that patients with small renal cell carcinomas are often surveilled with imaging, rather than treated with PA. Therefore, better awareness of the advantages and utility of PA in treating T1a renal cell carcinomas is needed. Last year, the Society of Interventional Radiology published a Position Statement on the role of PA in renal cell carcinoma, which was endorsed by the Canadian Association for Interventional Radiology and the Society of Interventional Oncology.1 The writing group consisted

RFA, and MWA. Regarding efficacy, four large database studies have shown that patients with small renal tumours treated with PA had acceptable, but mostly lower overall survival rates than those patients treated with surgery.2,3,4,5 However, when looking at cancer specific survival, two of the four studies showed no significant difference between PA and surgery. One study reported no difference in five-year overall survival between PA and surgery. These results reiterate the necessity for a randomised controlled trial comparing PA and surgery for small renal cell carcinomas, as these database studies may be biased by patient selection and other confounders. Despite the fact that a randomised clinical trial is often hampered by funding restraints, difficulties in recruitment of eligible patients, and political obstacles, it will be essential in further establishing safety and efficacy of PA.

Wind-down “watch and wait”

Multiple database studies have demonstrated the utility of adopting PA in lieu of active imaging surveillance.4,6,7 All studies showed that cancer-specific survival was higher for patients treated with PA than those subjected to surveillance and one study also demonstrated significantly greater overall survival rates for PA over active surveillance. These results seem to argue against the common practice of active imaging surveillance of small renal tumours, which would present large numbers of patients who would be more appropriately treated with PA. One of the greatest advantages of PA compared with surgery is its safety. Simply put, PA is associated with significantly fewer complications than surgery. Multiple cohort, registry-based studies, and systematic reviews have confirmed that complication rates and post-procedure renal function outcomes are better with PA than surgery in treating small renal tumours.3,4,8,9,10 As PA is often performed as an outpatient procedure, the length of stay is shorter for PA than surgery. In the cohort

One of the greatest advantages of percutaneous ablation compared with surgery is its safety.” of a multidisciplinary collection of experts who reviewed the pertinent literature. Although currently there are no randomised controlled trials comparing PA with surgery in renal cell carcinoma, the writing group found many population-based registry studies and systematic reviews of small cohort studies. The writing group concluded that PA is an acceptable treatment option for stage T1a renal cell carcinomas in carefully selected patients and can be offered over active surveillance. Of the three different PA modalities, the writing group found no significant differences in safety and efficacy between cryoablation,

and registry-based analyses, significantly lower complication rates were found for PA than surgery in the treatment of small renal cell carcinomas, with complications following PA ranging from 6 to 21% and the complications from surgery ranging from 29 to 40%. In one study, patients treated with PA had lower rates of acute renal failure when compared to surgery. Acute renal failure associated with PA was 3%, whereas it was 7% with partial nephrectomy and 11% with radical nephrectomy. A systematic review of 107 studies demonstrated lower rates of urine leak, acute kidney injury, and other urologic

complications, as well as shorter median hospital stay and decreased median blood loss in patients treated with PA vs. surgery.9 Another systematic review of 15 studies reported lower perioperative complications with PA than surgery.10 In addition, the surgery (partial nephrectomy) group was associated with decreased renal function at six-month and one-year follow up, compared to the PA patients. A large registry database study of 773 patients compared outcomes of PA of T1a tumours performed with cryoablation vs. thermal PA (either RFA or MWA)6. No significant difference in cancer-specific survival was found between cryoablation or thermal PA. The writing group also determined that a biopsy of a small renal tumour should be performed prior to PA at any time, either during the first part of the PA procedure or as a separate prior procedure. In addition, there may be a role for PA in treating some T1b (between 4 and 7cm in diameter) renal cell carcinomas and distant oligometastatic renal cell carcinoma in selected patients. Overall, PA appears to offer similar cancer-specific survival with fewer complications compared to partial nephrectomy for the treatment of small renal cell carcinomas. In addition, patients with T1a renal cell cancers tend to fare better when treated with PA compared to management with active surveillance. Although a randomised controlled trial is needed to further confirm the promising results of these population-based registry studies and systematic reviews of small cohort studies, IRs should expect a greater demand for PA of small renal tumours in the future. Christopher S Morris is a professor of Radiology and Surgery at Larner College of Medicine at the University of Vermont, Burlington, USA. He has reported no relevant disclosures. References 1 Morris CS, et al. Society of Interventional Radiology position statement on the role of percutaneous ablation in renal cell carcinoma: Endorsed by the Canadian Association for Interventional Radiology and the Society of Interventional Oncology. J Vasc Interv Radiol 2020, 31:189–94 2 Zhou M, et al. SEER study of ablation versus partial nephrectomy in cT1A renal cell carcinoma. Future Oncol 2018, 14:1711–9 3 Talenfeld AD, et al. Percutaneous ablation versus partial and radical nephrectomy for T1a renal cancer: A population-based analysis. Ann Intern Med 2018, 169:69–77 4 Xing M, et al. Comparative effectiveness of thermal ablation, surgical resection, and active surveillance for T1a renal cell carcinoma: A surveillance, epidemiology, and end results (SEER)–medicare-linked population study. Radiology 2018, 288:81–90 5 Uhlig J, et al. Ablation versus resection for stage 1A renal cell carcinoma: National variation in clinical management and selected outcomes. Radiology 2018, 288:889–97 6 Uhlig A, et al. Treatment for localized T1a clear cell renal cell carcinoma: survival benefit for cryosurgery and thermal ablation compared to deferred therapy. Cardiovas Interv Radiol 2018, 41:277–83 7 Larcher A, et al. Population-based assessment of cancer-specific mortality after local tumour ablation or observation for kidney cancer: A competing risks analysis. BJU Int 2016, 118:541–6 8 Larcher A, et al. Mortality, morbidity and healthcare expenditures after local tumour ablation or partial nephrectomy for T1A kidney cancer. Eur J Surg Oncol 2017, 43:815–22 9 Pierorazio PM, et al. Management of renal masses and localized renal cancer: systematic review and metaanalysis. J Urol 2016, 196:989–99 10 Hu X, et al. Partial nephrectomy versus ablative therapies for cT1a renal masses: A Systematic Review and meta-analysis. Eur J Surg Oncol 2019, 45:1527–35

Issue 83 | September 2021

Signal or Sludge? 17

Latest meta-analysis on paclitaxel in peripheral arterial disease provokes mixed reception “There appears to be heightened risk of major amputation after use of paclitaxel-coated balloons [PCBs] in the peripheral arteries,” findings from a systematic review and metaanalysis of randomised controlled trials (RCTs) published in the European Journal of Vascular and Endovascular Surgery (EJVES) suggest. However, the authors clarify that the level of evidence is graded moderate, not high, due to scarce events in some studies.

nd, leading physicians propose that the methodology used needs to be carefully considered and scrutinised before these conclusions are accepted. Clarifying at the outset that he is not an expert on statistical methodology, globally recognised leader in the development of new less-invasive procedures, Barry T Katzen, founder and medical director of Miami Cardiac & Vascular Institute, Miami, USA, and the president of the CLI Global Society, tells Interventional News: “As a physician engaged in multidisciplinary limb salvage with a view to improving quality of life by preventing amputations and death due to critical limb ischaemia, the conclusions from this meta-analysis are of concern, of course, and need to be taken seriously. However, in parallel I have questions about the complex

From a practical point of view, before accepting the conclusion regarding the risk of paclitaxel drugcoated balloon use, there needs to be a significant discussion and analysis of the methodologies employed in this paper.” Barry T Katzen

methodologies used in this paper to arrive at a finding that prospective RCTs have not demonstrated. From a practical point of view, before accepting the conclusion regarding the risk of paclitaxel drug-coated balloon use, there needs to be a significant discussion and analysis of the methodologies employed in this paper. This needs to be undertaken by appropriate statistical experts before these findings change practice, if they do so at all.” This latest meta-analysis, authored by Konstantinos Katsanos (Patras University Hospital, Patras, Greece) and co-authors from France, Germany, Finland and The Netherlands, drills down on the longterm risk of major amputation alone associated with use of PCBs in the lower limbs. The findings point to a significantly higher long-term risk of major limb loss using these devices in the femoropopliteal and/or infrapopliteal arteries. Anna Maria Belli, a former consultant radiologist and professor of Interventional Radiology at St. George’s Hospital and Medical School in London, UK, a past president of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE)

and proponent of evidence-based trials, comments: “It is essential that we have publications such as this interrogating data on new technologies in an unbiased way. There is a natural tendency to believe new technologies will provide better results than old ones. It is only by pooling results from published trials that enough numbers are amassed to detect trends which might be missed by individual trials. Katsanos and colleagues are to be commended for highlighting the increased risk of amputation with PCBs and, as they say, this now needs to be confirmed or refuted by further investigations.” Commenting on the publication in EJVES, Younes Jahangiri, statistical editor of the Journal of Vascular and Interventional Radiology (JVIR), says: “The manuscript has used a robust search strategy and metaanalysis techniques. Nevertheless, there are a considerable number of back-calculations and imputations that have been performed for data generation, which might not necessarily fit with real-world data. Additionally, exclusion of studies with no events in both arms, especially if the studies were of high quality and adequate follow-up, might have led to overestimation of the crude risk in both groups and potentially to the statistical significance of betweengroup differences. Although the meta-analysis itself suggests an alarming signal in a heavily computational way, confirmation of accuracy and adequacy of the signal would still require real-world targeted data.” The harm signals suggested for paclitaxel devices from previous meta-analyses have not been

87 2,216

41 1,544

Barry T Katzen

Anna Maria Belli

substantiated by a wealth of real-world datasets that have shown no long-term safety concerns, and instead suggested increased benefits with the use of paclitaxelcoated devices. Importantly, an interim mortality analysis of the SWEDEPAD registry randomised trial did not confirm a heightened mortality risk in cases of paclitaxel treatment, as noted in the EJVES paper. As reported in EJVES, the investigators performed a literature search last updated on 20 February 2021 to analyse 21 RCTs with 3,760 lower limbs treated nearly equally for intermittent claudication (52%) and chronic limb threatening ischaemia (CLTI; 48%). The median follow-up period was two years. Authors report 87 major amputations in 2,216 limbs in the paclitaxel arm (4% crude risk) compared with 41 major amputations in the 1,544 limbs in the control arm (2.7% crude risk). The risk of major amputation was significantly higher for paclitaxel-coated balloons with a hazard ratio (HR) of 1.66 (95% confidence interval 87 major [CI] 1.14–2.42; p=0.008, amputations in one stage stratified Cox model). The 2,216 limbs in the observed amputation paclitaxel arm risk played out equally (4% crude risk) across femoropopliteal (p=0.055) and infrapopliteal (p=0.055) arteries. The number 41 major amputations needed to harm was in 1,544 limbs in the 35 for CLTI. In this control arm (2.7% systematic review and crude risk) meta-analysis, authors suggest the summary effect demonstrated a 66% higher relative risk of major amputation in the limbs treated with PCBs, and call for further investigations. Further, Katsanos and colleagues write that there was good evidence of a significant non-linear dose relationship with accelerated risk per cumulative paclitaxel dose (chi square model p=0.007). The results were also stable across sensitivity analyses (clarified as pertaining to different models and subgroups, based on anatomy and clinical indication and excluding unpublished trials). Ziv Haskal (University of Virginia, Charlottesville, USA), the former editor (2011–2020) of the JVIR tells Interventional News: “Dr Katsanos and the research team stand, again, to shake-up the PCB planet with a suggested finding of worse amputation—the same goal paclitaxel was intended to make better, and with a dose-dependent effect. Unsurprisingly, it is a rigorous and clear-headed analysis. But there are interpolations, intercalations and imputations, likely to bring out critics, with force. This may be a curtain raiser, but the main play is yet to unfold.”

Ziv Haskal

September 2021 | Issue 83

18 Peripheral Vascular Intervention

Target lesion revascularisation in the firing line Is target lesion revascularisation (TLR) a meaningful clinical endpoint for research or should it be “tossed as a legitimate endpoint for peripheral vascular disease treatment success in US FDA [Food and Drug Administration] approval trials?” Recent keynote presentations and conference debate on appropriate care for peripheral vascular disease leave overuse of interventional therapy, particularly for claudication, staring down the end of a barrel. They also trigger a conversation around TLR becoming a target in and of itself.

im Hodgson, the 2019–2020 Society for Vascular Surgery (SVS) president, delivered a “delayed-due-to-COVID-19” presidential address at the 2021 Vascular Annual Meeting (SVS VAM 2021; 18–21 August, San Diego, USA and online) laying out a path to champion appropriateness in vascular care. He wasted little time in conveying the message he has long sought to convey to SVS members: that the threat posed to vascular surgery by a small number of “bad actors” carrying out inappropriate procedures is real—and that it is long past time to address the issue. The day after Hodgson introduced the concept during the Crawford Issues Forum, data were presented by Caitlin W Hicks, associate professor of Surgery at Johns Hopkins Medicine in Baltimore, USA, and colleagues at VAM on the overuse of early peripheral vascular interventions for claudication. Since then, further research has built upon the charge that outliers are performing inordinate levels of certain procedures, including atherectomy carried out in the office-based lab (OBL) setting. The impact of the explosive growth of atherectomy on patients and healthcare finances is problematic and growing exponentially, Hodgson lamented. He turned to further findings from Hicks showing that of the roughly US$267 million reimbursed by Medicare for first-time femoropopliteal peripheral vascular interventions in 2019, 90% was for atherectomy, “leaving only US$26 million to pay for all of the other therapies that actually have evidence showing that they work.” Hodgson called out what he called “the enablers” of this type of practice—“people or constructs that encourage or enable negative behaviour in others.” The Centers for Medicare & Medicaid Services (CMS) was one, with “distorted reimbursement incentives” contributing to the problem, he argued.

Left to right: Kim Hodgson, Caitlin W Hicks, Jim A Reekers, Joseph Mills

Another enabler is the FDA, Hodgson said, calling for TLR to be “tossed as a legitimate endpoint for peripheral vascular disease treatment success in FDA approval trials.” Hodgson also called out vascular surgery’s industry partners. He said they should be “the canary in the coalmine for inappropriateness. You are uniquely positioned to spot abuse early—before patients are harmed. You know every one of the outliers in vascular care.” Jim A Reekers, professor emeritus of Radiology at Amsterdam University, Amsterdam, The Netherlands, is currently the editor-in-chief of CVIR Endovascular and has served as president of several national and international organisations, such as the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) and the interventional radiology division of the European Union of Medical Specialists (UEMS). He tells Interventional News: “I read with great interest the address of Dr Hodgson during the 2021 iteration of VAM about inappropriateness in care. I fully agree with the content, and I am happy with this initiative for change. I truly hope that his address will mark the start of a new era where the patient will be again the focus of our work and not only the patient’s lesion. As mentioned by Dr Hodgson, there has never been any scientific evidence for atherectomy while there is overwhelming highquality evidence for SET [supervised exercise therapy], and there has been for a long time. Dr Hodgson also touched on the holy grail of TLR, which is instrumental to what he says about inappropriateness in care. TLR is a flawed and constructed pseudo endpoint for peripheral vascular disease treatment success, without any relation to real clinical patient outcome, benefitting only commercial trials (as published by Reekers in The Lancet in 2019). His idea that industry partners are uniquely positioned to spot abuse is true and needs no further discussion.”

Speaking at a separate VAM sponsored session on paclitaxel safety, which drew a mix of sceptical and cautious responses to the latest meta-analysis from interventional radiologist Konstantinos Katsanos and colleagues (Patras University Hospital, Patras, Greece), that reported a heightened risk of major amputation after use of paclitaxel-coated balloons (PCBs) in femoropopliteal and infrapopliteal arteries, Joseph Mills, professor and chief, Division of Vascular Surgery and Endovascular Therapy, Baylor College of Medicine, Houston, USA, and SVS vice president, made the point that there was a real need for studies that are redesigned to look at […] clinically significant endpoints for patients.” As specialists interested in patency, Mills continued, vascular providers tend to think that if a treated lesion stays patent for a bit longer, then the treatment “has got to be better for the patient. But the actual endpoint for a claudicant would be how far they can walk, what their quality of life is; and, for a chronic limb-threatening ischaemia (CLTI) patient, it is going to be: do they heal? do they have recurrent wounds? Those questions are a little bit different than the actual lesion-specific focus. I think if we can do anything from this, it would be to get industry to start looking at different endpoints.”

Sun continues to rise on SET app Hodgson also touched on another feature of his presidential year—the development of an SVS SET app. A simple, inexpensive means of treatment contrasted against expensive interventions, it lingers large over discussion of inappropriate care and overutilisation of certain procedures. “That supervised exercise therapy, or SET, works is perhaps the most solidly supported therapy in vascular care,” he said. “A 2017 Cochrane Review determined that ‘High-quality evidence shows that exercise programmes provide important benefit compared with placebo or usual care in improving both pain-free and maximum walking distance in people with leg pain from intermittent claudication.’ SET has also been shown to have considerable potential for savings in healthcare spending.” Why, asked Hodgson—with robust evidence of its effectiveness—is SET not used more often? “I think we all know that lack of reimbursement is just a minor part of the answer. Traditional SET requires patients to schedule an appointment, get at least a little bit cleaned up, travel to a facility, find a parking spot, and, because it is done in a gym setting, can be boring.” These types of drawbacks to traditional SET prompted the SVS leadership to establish a Health Information Task Force, now a standing committee, and ultimately develop the SVS SET app, Hodgson said. “We are currently enrolling in a randomised controlled trial to demonstrate the efficacy of the app in reducing or delaying the need for revascularisation, and a National Institutes of Health (NIH) grant application has been submitted by committee chair, Judith Lin, to further study the role of the SVS SET app as the initial treatment for claudication,” he added.

September 2021 | Issue 83

20 Advertorial THIS ADVERTORIAL IS SPONSORED BY ARGON MEDICAL DEVICES

Reliability, ease-of-use and availability have made SkaterTM drainage catheters a go-to product Placing a drain is an important, quotidian, “bread and butter” procedure that often has a tremendous impact on patients’ lives. “A drain is a drain until it is not,” says Sean Calhoun, who outlines the benefits of the Skater all-purpose, nephrostomy and biliary drainage catheters (Argon Medical Devices). He hones in on their anti-kinking and locking mechanisms, ease of insertion and transition and compatibility with both alcohol and doxycycline. Calhoun also shares his excitement about the recent commercial launch of the Skater mini-loop drainage catheters in the USA and the European Union, telling Interventional News: “I am hopeful that this will eliminate the problem of losing access to the abscess cavity by having the catheter track smoothly through the wall and into a small cavity. It is also going to be very helpful for external biliary drains.”

“T

he Skater drainage catheter is consistent, reliable, extremely easy to use and is visualised well under fluoroscopy due to its good radiopacity,” says Calhoun, vice chair of the Radiology Department and an interventional radiologist, Atlantic Health System, Morristown, USA. “Additionally, the locking mechanism is simple,

Case 1:

Lymphocoele drainage and sclerosis with Skater all-purpose drainage catheter 57-year old male post robotic prostatectomy with right pelvic lymphocoele and infected left pelvic lymphocoele. The patient underwent CTguided drainage with placement of a 10Fr Argon Skater drainage catheter on the left yielding 40ml cloudy lymphatic fluid and an 8Fr Argon Skater pigtail drainage catheter on the right yielding 90ml of lymphatic fluid. After the acute infection had cleared, bilateral lymphocoele sclerosis was performed with 98% dehydrated alcohol. The Skater drainage catheter is compatible with alcohol, minimising the risk of catheter breakdown and alcohol extravasation. One day later, contrast studies through the drainage catheters revealed near complete resolution of the lymphocoeles with no further output from either catheter. Both catheters were removed intact. A subsequent CT performed for prostate cancer surveillance demonstrated complete resolution of both lymphocoeles.

intuitive and designed for patient comfort in that it is not bulky. The break-off tab is very easy to use and very easy to undo when it is time to remove the catheter—these catheters are also perceived to have excellent patency rates, which are the key features for any drainage catheter,” he adds. Drainage is often seen as a quotidian, relatively routine procedure, with interventional radiologists placing five to 10 drainage catheters a week under different imaging modalities depending on the location. Drains are placed under imaging guidance for a wide variety of indications, including abscesses, biliary and ureteral obstructions, pleural effusions and pneumothoraces, Calhoun, who is also programme director for the Radiology Residency, indicates.

Case 2:

Skater mini-loop drainage catheter 80-year-old female with history of ovarian cancer and complicated sigmoid diverticulitis causing obstruction of distal left ureter. The patient underwent left percutaneous nephrostomy and antegrade ureteral stent placement. Due to the small renal pelvis, it was difficult to reform the pigtail of a standard nephrostomy tube. Therefore, a Skater mini-loop drainage catheter was used as a covering nephrostomy tube and was easily reformed in the small renal pelvis without disturbing the proximal loop of the ureteral stent.

An important point he emphasises is that while a drain is seen as a standard piece of equipment, there are subtle differences that are not appreciated until you have a drain that fails, commenting that “a drain is a drain until it is not”. This is when you really appreciate the differences in the technology and design and the many advantages offered by drains such as Skater, he notes. Calhoun particularly draws attention to the hydrophilic coating, resistance to kinking and accordioning—three things that contribute to the ease of insertion and the reliability of the device. “During insertion, drains can certainly accordion because the multiple side holes create a relative weakness in the catheter. I have had catheters in the past in which the side holes accordion, particularly in tight biliary strictures. This makes it very difficult to advance the drain. The Skater catheter seems to track very well through firm cirrhotic livers. When using other catheters in the past where there was challenging cirrhotic liver and a tight stricture, I recall going through several catheters that just continually weakened; that has almost never been the case with the Skater line. Those difficult situations now seem like distant memories, because we have been using this product for 10 years. “The concept of durability and not having the catheter break down necessitates patients having to come in for avoidable changes, particularly when we start using the catheters for things like lymphocoele sclerosis and cyst sclerosis with alcohol, during which some catheters can break down and fragment. I have also seen patients come in with their catheters in all sorts of disarray; they can have kinks, be twisted and become occlusive. While many patients keep them in pristine condition, others do not, and we have observed that the catheter is twisted and wrapped around and coiled under a dressing that has not been well cared for, oftentimes with the catheter not draining in that situation. This might lead the physician to believe that the catheter is occluded, but in fact, there is a kink in the catheter under the dressing; we have seen that with other manufacturers in the past. The Skater catheter appears to be much more resistant to kinking.”

Skater is compatible with both doxycycline and alcohol

One major advantage of the Skater catheter is that it is compatible with both alcohol and doxycycline. Calhoun explains why this dual compatibility is important: “Patients who have undergone drainage of a symptomatic cyst, a symptomatic renal cyst, or a hepatic cyst, or postoperative lymphocoele, will often be sclerosed to avoid cyst recurrence or

Case 3:

Skater biliary drain

75-year-old male with obstructive jaundice secondary to adenocarcinoma of the head of the pancreas and a history of endoscopic retrograde cholangiopancreatography-induced pancreatitis. Leftsided approach percutaneous biliary drainage was performed with placement of a 10Fr Skater biliary drainage catheter which passed easily across the common bile duct obstruction.

Issue 83 | September 2021

Advertorial 21

promote healing. The primary compound it has been our perception that the Skater that we use is alcohol, but doxycycline is catheters have a much lower rate of early another popular alternative these days with occlusion than some of the other catheters alcohol becoming less available due to that we have used in the past.” manufacturing shortages. Many of the other non-compatible catheters will break down Skater mini-loop launch during this sclerosing procedure. You hear received with enthusiasm horror stories of interventional radiologists Commenting on the recent commercial chasing catheter fragments in the cyst cavity, launch of the Skater mini loop catheter, an Sean Calhoun and trying to retrieve them can be very expansion of Argon’s Skater all-purpose difficult. Fragmentation is not only cumbersome, it and nephrostomy drainage portfolio, which uses a 40% puts the patient at risk. So, being able to confidently smaller loop to help secure the catheter and drain fluid use alcohol, or doxycycline, knowing that the catheter from smaller cavities, Calhoun says: “I have often been is going to stay intact is huge,” Calhoun elaborates. disappointed with the mini pigtail catheters available He also calls out the flow rates as being important. because the transition at the tip is unfortunately not “The fact that the Skater catheter has a consistent lumen even at the hub means that you avoid the problem of effectively putting in a smaller catheter than what you think you are putting in.”

Biliary drains and occlusions

Biliary drains can frequently be “management headaches” as patients, who are very sick with sepsis and life-threatening infections, can come in with occlusions. Early occlusions are very problematic for patients as they can lead to life-threatening infections. Other times it is just an inconvenience for the patient, notes Calhoun. “If there is poor drainage, it is often due to occlusion of the catheter side holes, so I think the skived side holes of the biliary drainage catheters certainly help to reduce the occlusion rates. All catheters are going to be subject to some rate of reocclusion, but

We have expanded our Skater inventory as there are multiple sizes and diameters available. We can always count on that catheter being on the shelf and having plenty of stock and it has now become our go-to product.”

Two “promising” new devices for venous valve replacement presented at SVS VAM

Photo 143676056 / Medical © Solarisys13 | Dreamstime.com

The progress of two “promising” new devices in the venous valve replacement space was outlined during a special session at the Society for Vascular Surgery’s Vascular Annual Meeting (SVS VAM 2021; 18–21 August, San Diego, USA and online) co-hosted by the American Venous Forum (AVF). ELLEN DILLAVOU, ASSOCIATE professor of Vascular Surgery at Duke University Medical Center in Durham, USA, placed a lens over the BlueLeaf system (InterVene) and the VenoValve (Hancock Jaff Laboratories). “The history of venous valve replacement is long and usually not successful,” Dillavou told attendees. Both autogenous and non-autogenous valves have been tried for years to replace those that have been damaged or congenitally absent in the leg, she continued, but “on the horizon we now have two very promising new products.” The BlueLeaf system, Dillavou explained, is an endovascular means to create a mono- or bicuspid valve. The system “takes the thickened intima of a post-thrombotic vein that is damaged and, with a dissector, gets a wire through that thickened vein wall, and then uses hydrodissection, balloon dissection and a mechanical dissector to form a pocket,” she said, adding: “Intravascular ultrasound (IVUS) is critical during the procedure—both in choosing the vein site as well as looking at the final result.”

Early results, which are in publication, indicate a 93% technical success rate “of creating at least a monocuspid valve,” with the researchers testing the system producing a mean of 1.3 valves per patient. The investigators reported having 10 patients at one-year followup, with no thrombotic events recorded, Dillavou noted. “Although they did not have a difference in the popliteal reflux time, they did have a decrease in the Venous Clinical Severity Score (VCSS).” Additionally, nine out of nine venous ulcers either healed or improved at the last follow-up, she added. Two-year post-VenoValve implantation data were reported by Jorge Ulloa (Fundacion Santa Fe-Universidad de los Andes, Bogota, Colombia), the principal investigator for the first-in-human VenoValve trial. Key highlights from Ulloa’s presentation indicate that: ■R eflux decreased from an average of 1.95 to an average of 0.72 (a 63% improvement) ■D isease manifestations (measured by revised Venous Clinical Severity

ideal to get into a small abscess cavity. In these small cavities, you do not have a lot of guidewire purchase, so you want the catheter to track smoothly and easily through the wall, so that you can situate it without losing purchase. In my experience the transition is much smoother and uniform with the Skater range than the other catheters out there, so I am hopeful that this will eliminate that problem. It is also going to be very helpful for external biliary drains. If it performs the same as the other catheters in terms of drainage and reliability, then we have hit a home run.”

Product support and availability matter

While the pandemic seems to have impacted the availability of product ranges across the board, the Skater device has been relatively unaffected. “My technologists are regularly flagging back orders. Matters can come to a head when a patient is already here, and we have to pivot to find other alternatives. That has not been the case with Skater catheters, or any of the Argon products, which are all manufactured in the USA. They have always been available and the product support has been excellent. We have expanded our Skater inventory as there are multiple sizes and diameters available. We can always count on that catheter being on the shelf and having plenty of stock and it has now become our go-to product,” says Calhoun.

Score [rVCSS]) decreased from an average of 13.38 to an average of 5.38 (a 60% improvement) ■P ain (measured by Visual Analogue Scale [VAS] scores) decreased from an average of 7.25 to an average of 0.5 (an improvement of 93%) ■T here were no safety issues or venous ulcer recurrences The data reported are for a group of eight patients who participated in the VenoValve first-in-human study and who agreed to participate in a one-year poststudy follow-up. Three additional first-inhuman patients elected to not participate in the one-year post-study follow-up but reported no negative VenoValve-related events during the one-year follow-up period. The average post-VenoValve implantation time for this cohort of patients is two years, and the comparative results are based on pre-VenoValve levels compared to the patients’ most recent office visit. Marc Glickman, Hancock Jaffe’s

Structure of normal and varicose veins

senior vice president and chief medical officer stated, “These data are exactly the results that we were looking for as we begin our VenoValve SAVVE [Surgical anti-reflux venous valve endoprosthesis] pivotal trial.” The SAVVE US pivotal trial for the VenoValve will include 75 patients at up to 20 sites. The primary endpoints will be the same as for the first-in-human trial: the primary safety endpoint is the occurrence of a major adverse event (MAE) in less than 10% of patients at 30 days post-VenoValve implantation, and the primary effectiveness endpoint is improvement of reflux equal to or greater than 30% at six months following VenoValve surgery. MAEs are defined as the composite of all-cause mortality, deep wound infection, major bleeding, ipsilateral deep vein thrombosis (DVT), or pulmonary embolism. Improvement of VCSS and VAS scores are also included in the SAVVE study as secondary endpoints.

September 2021 | Issue 83

22 Interview

PROFILE

Maureen Kohi

“I strongly believe that you cannot be what you cannot see. If you want more women or under-represented minorities (URMs) to enter the field and be at the table, then we need more women and URM leaders in the field,” Maureen Kohi (Chapel Hill, USA) tells Interventional News.

My ‘a-ha’ moment that drew me into a career in vascular and interventional radiology was during my third year of medical school. I had observed countless prolonged open surgeries, and then scrubbed into one of my first cases of endovascular aneurysm repair of the abdominal aorta. I was moved by the precise and delicate deployment of the stent graft by a ‘vascular and interventional radiologist’ who forestalled a major abdominal surgery and resulted in the patient experiencing a quicker post-procedure recovery, faster hospital discharge, and lower complication rates. I loved the innovation of the field, the efficiency of the procedures, the delicate and yet deliberate procedural dance, and the monumental impact on clinical care provided through a pinhole. I knew I would be destined to become a vascular and interventional radiologist.

Who have been your mentors?

I owe my entire career to my mentors and sponsors along the way, as I truly believe we stand on the shoulders of giants, and I am forever grateful for their support. My most impactful mentor was Ernie Ring, who showed me the glorious world of academic interventional radiology. At the University of California, San Francisco (UCSF), I owe my research and academic success to my research mentors Karen Ordovas and Sharmila Majumdar who taught me how to become a physician-scientist and a research mentor. I also felt so incredibly supported and promoted by my chairman, Ron Arenson, who encouraged me to pursue a leadership career in radiology. During my junior faculty years, I was very fortunate to meet several luminaries who took me under their wing and helped to mentor and sponsor my career. I am forever indebted to Anne Roberts, Barry Katzen, Dan Sze, Jafar Golzarian, Jim Benenati, Jim Spies, Laura Findeiss, Mahmood Razavi, Mike Dake, Mike Darcy, Kathy Krol, Lindsay Machan and Ziv Haskal. During my transition from division chief to department chair, I relied a great deal on support and mentorship from Alan Matsumoto, Bob Ryu, Chuck Ray, Jim Spies, John Kaufman, Matt Mauro, and Reed Omary. Throughout my career, I have been very fortunate to have tremendous women peer mentors and I do not believe I could be where I am without the love and support of Kari Nelson, Theresa Caridi, Nadine Abi-Jaoudeh, Alda Tam, Alex Barnacle, Gloria Hwang, Janice Newsome, Nishita Kothary, Isabel Newton and Tze Wah.

Has COVID-19 provoked new ways of working for the interventional radiologist long-term? In the clinical realm, we have learned a great deal about telehealth and the ability to offer our services to remote areas. In education, we have learned to leverage virtual platforms for conferences, grand rounds, and guest speakers. However, as good as we have become at assembling virtual meetings, I feel we all crave the inperson experience of socialising and networking. While the virtual component is ‘good enough’, it does not come close to the ideal of in-person meetings. In short, COVID-19 has taught us how to pivot, be nimble, and evolve, but some things are best left in the ‘old world’ such as meeting in-person, without social distancing,

and masks. I really hope we can get back to that ‘old normal’ real soon!

Could you share a positive and negative experience you have had as a woman leader, and how you dealt with both?

As a female leader, I find any interaction where I promote or recruit a woman into the field of radiology or interventional radiology or within its leadership as a positive experience. Most recently, my most positive experience was my privilege to name Gloria Salazar as the very first woman Latin X division chief of Vascular Interventional Radiology at University of North Carolina and also nationwide. I have been fortunate in not having encountered many negative experiences as a female leader. However, the one that comes to mind is being repeatedly mistaken as a medical student, resident, fellow, nurse, or technologist. Once I was written up by a patient who felt I was a resident who placed her chest port when I was a first-year junior faculty. It reminds me of the eternal unconscious bias that as a young-appearing woman interventional radiologist, I look like every other member of the team, except for the attending physician or the leader of the team.

While the virtual component is ‘good enough’, it does not come close to the ideal of inperson meetings. In short, COVID-19 has taught us how to pivot, be nimble, and evolve.” Could you describe your interventional radiology-suite personality?

I am a very efficient and fast-paced person who plans multiple steps ahead and enjoys a brisk procedural dance. I also like to set a relaxed and social procedural environment where I can teach my trainees about how I do a variety of procedures and also use the time to learn more about them. However, when the procedure gets more complicated or things are not going according to plan, I become quieter and more deliberate, knowing that as the attending, I set the cadence in the room. The calmer I am, the more relaxed the environment. The patient is always the focus of our work and the closer and more connected we are as a team, the more successful we will be at delivering excellent patient care.

What is the most exciting way of attracting women and URMs to the interventional radiology table?

I strongly believe that you cannot be what you cannot see. If you want more women or URMs to enter the field and be at the table, then we need more women and URM leaders in the field. We only have one woman interventional radiologist as department chair and currently there are no URM IRs as department chairs.

alisonlang.com

What attracted you to a career in interventional radiology?

There are no women or URM IRs as deans or CEOs of medical centres. However, we are seeing numerous women IRs become division chiefs and programme directors. This is the first step to bridging the gender and racial gap to ensure we have excellent role models at the table to attract the next generation of leaders, particularly women and URMs into the field.

In the last year, which new research paper has caught your attention?

One of the most interesting manuscripts was the publication of the FEMME (Fibroids with either embolisation or myomectomy to measure the effect) trial, which was a randomised controlled trial comparing quality of life associated with the two treatments among women wishing to avoid hysterectomy. The primary outcome of this trial was the change in the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire after two years. This trial was the very

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Interview 23 first of its kind to have a very diverse population with a large number of African American participants, women with large uteruses, and severe fibroid symptoms. The trial demonstrated that the myomectomy group had a longer hospital stay and almost double the complications than the uterine fibroid embolization (UFE) group. While both groups demonstrated improvement in their UFS-QOL scores after therapy, the myomectomy group demonstrated a slightly higher improvement compared to the UFE group. Overall, the trial demonstrated that UFE and myomectomy are more alike than different. In addition, it demonstrated that compared to myomectomy, UFE resulted in post-embolization syndrome, shorter hospital stay, quicker return to work, fewer severe adverse events, and potentially comparable fertility outcomes.

Could you describe a memorable case?

I was consulted about a 23-year-old female who had presented with massive vaginal bleeding due to a uterine arteriovenous fistula (AVF) following a dilation and curettage (D&C). She underwent UFE with particulate embolization, which was unsuccessful and continued to experience severe vaginal bleeding and was planned to undergo a hysterectomy. I was fortunate to have been consulted to see if there was any way to preserve her fertility. I was able to embolize the AVF by directly puncturing and embolizing the nidus using ethylene vinyl alcohol copolymer. She went on to have a quick recovery and then become pregnant and give birth to a healthy baby. The case taught me that the innovative spirit of interventional radiology lives in all of us. In addition, it reminded me that we should not be so quick to recommend hysterectomy. Instead, we should take a step back and think of what else we can offer to preserve fertility and avert hysterectomy. We would never do a nephrectomy for a renal AVF or a pneumonectomy for a pulmonary arteriovenous malformation. So why remove a woman’s uterus because of a fistula? Go direct and obliterate the fistula, retain fertility, and avoid hysterectomy.

What interests you outside of medicine? I most enjoy spending time with my 11-year-old son, husband, dog and our friends. I also love all things athletic: running, biking, hiking, kayaking, jet skiing, or going to a baseball or basketball game. I am a huge Tar Heel fan, so anything that applies to the University of North Carolina. I am inspired by music and played trombone in the Stanford band. My other interests include baking, travelling, and wine. Reading a book (anything by Jane Austen) at the beach with my feet in the water while my son and husband body surf is a favourite pastime. As I grew up in Northern California, I love wine tasting and learning about how wine is made. Moving to the South my interests have expanded into visiting breweries and distilleries and learning more about Southern cooking.

Selected honours and awards Current and past appointments

2020–present: Chair, Department of Radiology, University of North Carolina, Chapel Hill, USA 2020–present: Ernest H Wood Distinguished professor and chair, Department of Radiology, University of North Carolina, Chapel Hill, USA 2017–20: Chief, Interventional Radiology, University of California, San Francisco, USA

2021: Inducted as Fellow of the Cardiovascular and Interventional Radiological Society of Europe (FCIRSE) 2020: Volunteer Service Award, American Board of Radiology 2020: Women of UCSF Health Spotlight Award, University of California, San Francisco 2020: Inducted as Fellow of the American Heart Association (FAHA) 2017: Certificate of Merit for an Educational Exhibit, Radiological Society of North America 2017: Inducted as Fellow of the Society of Interventional Radiology (FSIR)

Medical education

2011–12: Fellowship, University of California, Women’s Imaging, University of California, San Francisco 2010–11: Fellowship, University of California, Vascular and Interventional Radiology, University of California, San Francisco 2006–10: Residency, University of California, Diagnostic Radiology, University of California, San Francisco 2005–06: Internship, California Pacific Medical Center, San Francisco, USA, Internal Medicine 2001–05: MD, New York Medical College, Valhalla, USA

24 WavelinQTM EndoAVF System: The radial approach from a vascular surgery perspective / Advertorial

September 2021 | Issue 83

The WavelinQ™ EndoAVF System takes an innovative approach in creating endovascular AV fistula (endoAVF) for dialysis patients. Rethink fistula creation and maintenance with Tobias Steinke, Ounali Jaffer, Panagiotis Kitrou and Robert Jones in this four-page advertorial, sponsored by BD.

Minimally-invasive, outpatient WavelinQ offers an alternative to open surgery According to Tobias Steinke, head of Vascular and Endovascular Surgery, Schoen Klinik Duesseldorf, Duesseldorf, Germany, patients are often keen to undergo minimally invasive procedures and may prefer these to open surgical options. As a vascular surgeon, the WavelinQ System offers additional anatomic sites for percutaneous arteriovenous fistula (AVF) creation that may not compromise surgical alternatives, which is a really important aspect, according to Steinke.

multidisciplinary team involving nephrologists, vascular surgeons, interventional radiologists, anaesthetists, nurses and vascular technologists is key to approaching decision-making before AVF creation, says Steinke. “It is quite important that all the physicians involved in creating, using and maintaining AVFs communicate with each other. How quickly is this access required for needling? Which options allow the quickest needling of the access?” These are examples of questions that generate multidisciplinary discussion, he notes. “In our practice, if there is time and the patient is young, we prefer to begin with a surgical creation of a radiocephalic fistula, because long-term, if it works as intended, this will be the best option. If we have a Parallel: Access from upper arm (brachial artery/ brachial vein)

Target Creation Site

WavelinQ offers the option of creating EndoAVF at multiple creation sites in the forearm

patient who needs an access quite quickly, we usually move to the level of the elbow and again, surgically create a brachiocephalic fistula, which often has a shorter maturation time. The EndoAVF options can be used for patients who have vessels with accepted criteria, Tobias Steinke and work very well as they are positioned in the “middle ground” between the two surgical options at the wrist and above the arm,” explains Steinke. WavelinQ EndoAVF creation offers versatility in enabling multiple creation sites. “There are several anatomical options: lateral radial vein; medial radial vein; lateral ulnar vein; medial ulnar vein; and the location of the perforator plays a role as well. The target creation site should be as close as possible to the perforator to create conditions for the outflow to enable large amounts of blood to pass through these vessels for dialysis,” elaborates Steinke. “The case I am about to discuss involved a patient with end-stage renal disease. He had a surgically created radiocephalic fistula, which failed over time.

The next distal option to create another AVF, before going directly to the level of the elbow to create a brachiocephalic surgical fistula was at the lateral radial vein in direct connection with the perforator. The patient’s vessels were highly suitable for WavelinQ EndoAVF creation with the perforator optimally located to create a radial-radial fistula. In assessing vessel suitability for EndoAVF creation I always look at the diameter of vessels, location of the perforator and calcification. “Vessel mapping is mission critical. Operators really do have to understand the relationship between the arteries and veins in the arm and how the deep venous system is connected to the superficial venous system, especially with reference to the perforator vein. You have to construct a three-dimensional mind map of the venous and arterial system to establish the ideal location to create the AVF. So, proper vessel mapping, and really knowing how those veins are connected to each other is essential to be successful,” he concludes.

WavelinQ EndoAVF creation results in little or no disfigurement, which often convinces patients, especially those who refuse open surgery, to undergo the procedure.”

My procedural considerations

Target Creation Site

• Practising ultrasound puncture techniques is critical. There is a learning curve associated with this aspect, especially when puncturing the vein. Therefore, practice makes perfect. Moreover, procedural success also rests on puncturing the radial artery, which is usually pretty small (2mm) and this can also be challenging.

Parallel: Access from wrist (ulnar artery /ulnar vein or radial artery/radial vein)

• Always consider coiling during the procedure if the anatomy allows. Coils should be placed proximally to the created EndoAVF so that the venous outflow into the deep venous system is embolised and you direct the flow up to the superficial system. This can help facilitate maturation. • Always check the deep radial veins in different views that is parallel to the brachial artery above the elbow.

Anti-Parallel: Access from wrist (ulnar vein) and upper arm (brachial artery)

• Use the several connecting bridges from the medial to the lateral radial vein, which allow crossing from one side to the other to get the best parallel wire position during the procedure. Interventionalists may use those bridges to cross over with a guidewire to find the best catheter position. Some operators prefer to puncture the vein and then go straight up.

Target Creation Site Figure 1. Advancing venous catheter using a valve crosser to protect the electrode. Figure 2. The tissue gap before and after the delivery of radiofrequency energy. Figure 3. Post-creation fistulogram

• Aim to create the AVF as near as possible to the perforator.

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Advertorial / WavelinQ™ EndoAVF System: The wrist approach from an interventional radiology perspective 25

Patients’ wishes and multidisciplinary approach central to EndoAVF creation with WavelinQ “I am a firm advocate of informed patient choice whereby every patient is actively involved in the treatment that they actually receive. In the case described below, the patient went to see his nephrologist, having seen an article in the local newspaper about our hospital being the first to offer the endovascular arteriovenous fistula (EndoAVF) creation procedure within the UK’s National Health Service (NHS).

“T

he patient was then referred to our multidisciplinary clinic and all options were presented by the appropriate specialists, after which he remained set on having an WavelinQTM EndoAVF System,” says Ounali Jaffer, interventional radiologist and Interventional Radiology Research and Innovation lead at Barts Health, London, UK. “The rationale for choosing the EndoAVF approach in this particular patient was driven by the fact that he actively sought out the procedure but most importantly because it was the right option for him. While there were several other centres who had performed this procedure in a research setting, we at the Royal London were the first in the UK to offer the service on the NHS. The ensuing publicity, and our engagement with local patient groups have helped spread the message of this relatively novel treatment,” explains Jaffer, who is My procedural considerations • Adhere to the recommended guidelines in terms of vessel size—2mm or more in diameter at the access as well as the creation site for both the ulnar and the radial artery and concomitant veins. Outflow veins such as the cephalic need to be at least 2.5mm to allow for maturation. When screening, always start with assessment of the perforator vein as this may not be present in up to 15% of patients and ensure that is greater than 2mm. Especially when starting out, you have to be disciplined in the cases you pick by adhering to the guidelines and thereby minimising potential problems and maximising the chance of success in the first few cases.

My patient selection flowchart Patients considered healthy enough to have a standard endovascular procedure and an arteriovenous fistula qualify for further assessment

• Consider vascular anomalies. Sometimes there is more than one perforator. • When using the wrist approach, assess that both anatomically and physically (i.e. Allen’s or Barbeau test) to make sure it is suitable. • Ensure that postprocedure aftercare is very standardised. If reintervention is required, this should be done at the most optimum timepoint to reduce the risk of arterialisation to the deep veins or any maturation challenges. • When you perform a venogram and are unsure about the anatomy, especially above the elbow, remember you have an ultrasound in your hand. Use the two imaging modalities in conjunction to problem solve.

Perform ultrasound assessment – Tourniquet up – Patient has normal hydration

Confirmation of the creation site with identification of the perforator

also deputy director, Research, Group Clinical Services at the hospital.

Multidisciplinary team invested in EndoAVF critical to success

Jaffer also emphasises how vital the multidisciplinary approach is to the successful creation of EndoAVF. “We have a very defined, focused multidisciplinary team approach with nephrologists, vascular access surgeons, interventional radiologists, and very importantly clinical nurse specialists, lead dialysis nurses and vascular scientists. All of us are focused on building the success of the programme and ensuring it is patientcentric; at every stage, the patient’s voice will be heard and passed on to the other groups when relevant to do so. We have a weekly vascular access meeting in which all EndoAVF cases performed are discussed and all future options assessed.” Jaffer particularly draws out that decision-making is underpinned by the Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines in that the fistula creation is geared to deliver the “right access, in the right patient, at the right time, for the right reasons”. From a practical standpoint, EndoAVF creation relies firmly on an incredibly robust ultrasound screening programme to ensure that the patient’s vasculature is suitable as anatomy obviously drives the choice of percutaneous device quite strongly, he clarifies. The team at Barts Health favours starting with the radiocephalic surgical option. “If this is a no-go, or has been used, then we always consider a percutaneous option before we go above the elbow. I think as time evolves, there will be an algorithm, which is specific to how we incorporate endovascular AVF creation, both in terms of the particular device used and how it fits in with surgical options,” Jaffer opines.

Ounali Jaffer

Avoidance of scars and additional anatomic locations for AVF creation

There are certain aspects that make the WavelinQ a very attractive option, and Jaffer particularly draws out the lack of creation scarring, versatility in terms of future surgical options and ease of use. “We cannot underestimate or discount the impact of haemodialysis on a patient’s life. Often, life has been turned on its head for patients. They are suddenly having to go to a hospital or a dialysis centre thrice a week, which has a tremendous psychological effect. With the percutaneous Upper arm vein(s) ≥2.5mm diameter?

Perforator present, feeding upper arm vein(s)?

Perforator vein on ultrasound

Post-creation arteriogram

approach, firstly, you avoid surgical creation scarring, which is an important factor for many people, and it might be the reason that they are refusing to have a surgical option and choose instead to stay on a line, which traditionally has much higher rates of morbidity and mortality. “Secondly, with the WavelinQ EndoAVF System, you can get a split flow, or maturation of two veins, which may lead to a longer length than you would with above-arm fistulas in terms of areas that you can cannulate. The procedure I performed did not take away future surgical options. Indeed, it simply provides choices for AVF creation for patients who have a finite number of alternatives. In my opinion, the WavelinQ device is user friendly in terms of the actual procedure,” he says. Furthermore, WavelinQ is a complete programme in that the screening, AVF creation and post-procedural aspects such as maturation and cannulation are equally important. “Every aspect along the entire pathway has to be completely on the ball to get to that patency rate that you are looking for. There is obviously a learning curve, as with any device, but this is relatively quick and the support from the company, for the procedure, preprocedural planning, and the postprocedural maturation and cannulation aspects is very good,” he notes. Brachial, radial or ulnar artery ≥2mm diameter? At least one brachial vein ≥2mm diameter?

Not an EndoAVF candidate

At least one ulnar or radial vein ≥2mm diameter?

EndoAVF candidate

Not an EndoAVF candidate

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26 WavelinQTM EndoAVF System: The antiparallel approach / Advertorial

Screening with ultrasound and vessel mapping prerequisite to success with WavelinQ™ EndoAVF System Focusing on the importance of vessel mapping and its impact on his team’s choice of WavelinQ for EndoAVF creation, Panagiotis Kitrou, assistant professor in interventional radiology at Patras University Hospital in Patras, Greece, says: “Screening of the patient with ultrasound is a prerequisite. This is true not only for percutaneously created fistulas but also for those created surgically.”

“W

hen using WavelinQ in particular, apart from being the main exam for eligibility, it also offers the ability to plan the procedure in terms of access. There is also the advantage of coming up with a back-up plan, as in most cases, more than one access option is available.”

Emerging evidence in support of EndoAVF

Commenting on the data evolving in 2021 to back EndoAVF, Kitrou asserts that this is “still in its infancy”. “There are few studies available, and the number of patients recruited in these studies is still small, but the initial results are very encouraging. However, BD has an extensive clinical programme regarding WavelinQ with two studies, the CONNECT-AV in the USA and the WAVE-Global, set to recruit more than 400 patients and aiming to provide a significant amount of evidence regarding the technology. CONNECT-AV is a prospective, single-arm, open-label study that will follow patients treated with My procedural the WavelinQ EndoAVF considerations System for 24 months. The study’s dual primary • No shortcuts! Because of the effectiveness endpoints are versatility of options the percentage of patients provided both for dialysing using successful creation and access two-needle cannulation for with WavelinQ, one should respect all at least 75% of the dialysis the steps of the sessions over a continuous procedure. 28-day period at six months, and the patients

maintaining primary patency at six months. The primary safety endpoint is freedom from device and procedure-related serious adverse events through 30 days. The trial is expected to enrol 280 patients in the USA. Panagiotis Kitrou Similarly, WAVE-Global is a prospective, single-arm, open-label study that will follow patients treated with the WavelinQ EndoAVF System for 24 months. The primary endpoints are the number of interventions needed post-creation to facilitate and/or maintain AV fistula use at six months, and the proportion of participants with freedom from clinical events committee adjudicated device- or procedure-related serious adverse events at 30 days. The trial is expected to enrol 150 participants globally (outside of the USA).

Choosing EndoAVF and the antiparallel approach

An important consideration when making the choice to perform percutaneous AVF creation, for Kitrou, is that it is not antagonistic to surgical fistula creation. “It is complementary and provides additional options for AVF creation for the patient. The WavelinQ device in particular offers four potential added sites for anastomosis. Moreover, EndoAVF creation may not compromise future surgical options.” Specifically commenting on the different approaches, Kitrou says: “Once the vessels of creation are decided, the vessels of access should be chosen. I prefer accessing

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the wrist vessels. In the case of the artery, the wrist is more superficial, enabling an ease to post-intervention compression. When venous puncture is undertaken, wrist access is antegrade to venous flow. This may offer better opacification of the venous network and better valve negotiation compared to brachial access. If one of those is not possible, then brachial access is the next choice and this leads to the antiparallel approach. Again, I would like to emphasise that vessel mapping is a prerequisite and a key to success.” Kitrou explains how the development of EndoAVF has provided interventional radiologists with the option to perform fistula creation. “In my centre, as an interventional radiologist I was not involved in fistula creation in the past. This percutaneous option has allowed our discipline to get involved. We have extensively discussed the matter in our dialysis multidisciplinary meeting and decided to include WavelinQ into our algorithm three years ago. Every decision we make to create an EndoAVF is a multidisciplinary decision. Additionally, when patients are offered a less-invasive option, they often prefer it to the surgical option. We have now treated more than 40 patients, in a hospital that was never a reference centre for AVF creation, and the results, so far, are encouraging.”

Percutaneous AVF creation is not antagonistic to surgical fistula creation. It is complementary […] WavelinQ, in particular, offers four potential extra sites for anastomosis.”

Figure 1. Image of the patient’s left hand. Arrows show the antiparallel approach with the arterial puncture from the wrist (ulnar artery) and the venous puncture from the upper arm (lateral brachial vein) Figure 2. Catheter alignment at the level of the forearm prior to activation Figure 3. Final fistulogram showing the different parts of the vascular access circuit. Following the blood flow: ulnar artery > anastomosis > lateral ulnar vein > perforator > cephalic vein/median cubital vein – basilic vein. The coiled lateral brachial vein is also indicated

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Advertorial / WavelinQ™ EndoAVF System: Secondary interventions 27

Utilising angioplasty to treat stenosis post EndoAVF Reinterventions following WavelinQ™ EndoAVF System creation may be required. The go-to procedure remains balloon angioplasty. Angioplasty in this setting is occasionally needed to treat stenosis of the perforator and deep vein segment adjacent to the arteriovenous (AV) communication.

obert Jones, consultant interventional radiologist at the Queen Elizabeth Hospital, Birmingham, UK, says: “Our experience has revealed that secondary interventions—primarily angioplasty, are effective if a stenosis develops and, less commonly, embolization of venous tributaries is required for diverting flow superficially to aid fistula flow and maturation. In a data-scarce field, a “typical” timeframe for reinterventions is hard to pinpoint with accuracy at this stage. We have learnt a lot about secondary interventions after WavelinQ EndoAVF at my centre and are in the process of analysing our data.” The two main categories that secondary reintervention fall into, in Jones’s practice, are those aimed at promoting maturation, and those to maintain patency, such as angioplasty of problematic stenoses. He also clarifies that some WavelinQ EndoAVF failing to mature may be the result of stenosis that develops early on. With increasing experience and understanding in the relatively new and novel space of EndoAVF creation and maintenance, the approach to secondary treatment is evolving, he clarifies. “Early on, when we identified small numbers of EndoAVF that failed to mature, we followed a protocol of coil embolizing deep veins or collaterals to promote maturation. I now wonder whether we were overlooking underlying subtle stenosis at the time,” says Jones, who is also the treasurer of the Vascular Access Society of Britain & Ireland (VASBI). With the WavelinQ EndoAVF system offering many options for fistula creation at multiple anatomical sites in the proximal forearm (ulnar-ulnar vein or radialradial), Jones makes the point that further experience will be required to determine whether there is a difference regarding the types of problems that emerge, and reinterventions needed between the two sites of fistulas. Explaining the evaluations used to guide any secondary interventions, Jones identifies reviewing fistula creation angiograms; relevant ultrasound findings; assessing the clinical status of the patient; and the functional status of the fistula as key considerations before planning the procedure. “The first thing I would want to review is the imaging from the original fistula creation. Secondly, I would assess the current clinical

and dialysis information in conjunction with previous imaging. Was the patient dialysing well before the problem arose, or is this an issue of poor function and maturity from the beginning? Then, I would look at any Robert Jones current and relevant ultrasound findings to assess whether the fistula is still patent or not, because that is an important consideration,” he says. Jones elaborates that while the principles of reintervening in surgical fistulas are similar to those created percutaneously. With the latter, the approach needs to be more tailored to the individual patient in terms of the configuration of the fistula and location of problem. “With WavelinQ EndoAVF, the AV communication is side-to-side, there are multiple outflow veins and therefore the anatomy is very different to the traditional wrist or above elbow surgical fistula. Traditionally, for a dysfunctional surgical fistula, we would perform an

ultrasound/Doppler in the first instance to establish whether there is a stenosis or occlusion. With a WavelinQ EndoAVF, because there are multiple outflow veins, and the location of the AV communication is deeper, the problem can be more challenging to precisely identify with ultrasound but this is still an important, non-invasive, first-line investigation, especially in assessing brachial artery inflow rates. A subtle stenosis in the deep veins in proximity to the AV communication could easily be overlooked with ultrasound. You really need an

• Carry out a diagnostic fistulogram from the arterial side in the first instance and it is useful to have a higher digital subtraction angiography frame rate when performing the angiogram, with oblique projections often helpful.

• If there is a stenosis, it is often observed in the juxta-arteriovenous communication deep vein or perforator, rather than the outflow veins. Scrutinise this region in detail. • My preferred approach to intervention is a separate venous access to avoid upsizing the arterial access. • Aim for a ‘straight-shot’ to the problem—plan to treat any stenosis or coil embolizations via the straightest possible route, as it can be challenging to negotiate tortuous anatomy, especially via the AV communication.

Case for secondary intervention

The patient is a 70-year-old man with a left ulnarulnar WavelinQ EndoAVF created in 2018. The patient had had previous secondary interventions, previous angioplasties of the perforator vein and juxtaanastomotic lateral ulnar vein since fistula creation to treat recurrent stenosis. Each of these interventions resulting in significantly improved dialysis function. He recently reported difficulty in needling the fistula and poor thrill. There was also a drop in brachial artery flow demonstrated on ultrasound from a baseline of 1,600ml/min to 450ml/min. These were the indications for intervention.

WavelinQ™ Venous and Arterial Catheter

My procedural considerations

• Carefully ascertain whether there is a stenosis; or are there competing venous outflow issues?

angiogram from the arterial side to get a clear idea of what is happening. “Firstly, I either puncture the relevant artery at the wrist, or the brachial artery above the elbow, with a micropuncture set and carry out a diagnostic fistulogram to establish whether there is a stenosis and to assess the outflow dynamics to ascertain if there are competing deep veins or collaterals that may have developed that could be stealing flow from the superficial veins. This diagnostic fistulogram then allows planning of interventions—angioplasty (to treat stenosis) or coiling (to embolize deep veins or collaterals to promote more superficial flow to the cannulation sites). Often, a second access point is called for. So rather than approaching a stenosis, for example, from the arterial access that has been gained to obtain the diagnostic angiogram, we might need to obtain access in the relevant outflow vein,” he emphasises.

Figure 1. Pre-angioplasty angiogram

Figure 2. Post-intervention angiogram demonstrating improved appearances

Following a diagnostic fistulogram from the arterial side, Jones gained retrograde access in the cephalic vein in the upper arm and performed an angioplasty of the perforator stenosis in a straight-line fashion, without having to cross the AV communication (Fig 1 and 2).

The go-to procedure remains balloon angioplasty. Angioplasty in this setting is occasionally needed to treat stenosis of the perforator and deep vein segment adjacent to the arteriovenous (AV) communication.”

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28 Advertorial

Disclaimer: Please consult Becton, Dickinson and Company product labels and inserts for any indications, contraindications, hazards, warnings, cautions and instructions for use. The opinions and clinical experiences presented herein are for informational purposes only. The results from this case report may not be predictive for all patients. Individual results may vary depending on a variety of patient specific attributes. The clinicians have been compensated by Becton, Dickinson and Company to participate in this presentation.

WavelinQ™ EndoAVF System (WavelinQ™ System, WavelinQ™ or REF WQ4305) Components

INDICATIONS: The WavelinQ™ EndoAVF System is intended for the cutting and coagulation of blood vessel tissue in the peripheral vasculature for the creation of an arteriovenous fistula used for hemodialysis. CONTRAINDICATIONS: Known central venous stenosis or upper extremity venous occlusion on the same side as the planned AVF creation. Known allergy or reaction to any drugs/fluids used in this procedure. Known adverse effects to moderate sedation and/or anesthesia. Distance between target artery and vein > 1.5 mm. Target vessels < 2 mm in diameter.

WARNINGS: The WavelinQTM EndoAVF System is only to be used with the approved commercially available devices specified in the IFU. Do not attempt to substitute non-approved devices or use any component of this system with any other medical device system. The WavelinQTM EndoAVF System catheters are single use devices. DO NOT re-sterilize or re-use either catheter. Potential hazards of reuse include infection, device mechanical failure, or electrical failure, potentially resulting in serious injury or death. Use caution when performing electrosurgery in the presence of pacemakers. Improper use could damage insulation that may result in injury to the patient or operating room personnel. Do not plug device into the electrosurgical pencil with ESU on. Keep active accessories away from patient when not in use. Do not permit cable to be parallel to and/or in close proximity to leads of other devices. Do not wrap cable around handles of metallic objects such as hemostats. Consult the ESU User’s Guide on its proper operation prior to use. Do not use closure devices not indicated to close the artery used for access. CAUTIONS: Only physicians trained and experienced in endovascular techniques should use the device. Adhere to universal precautions when utilizing the device. Do not kink, pinch, cut, bend, twist, or pull excessively or with excessive force on any portion of the devices. Damage to the catheter body may cause the device to become inoperable. Avoid sharp bends. This may cause the device to become inoperable. Do not pinch or grasp the catheter

with excessive force or with other instruments. This may cause the device to become inoperable. Do not bend the rigid portion of the catheter near the electrode or backstop. Do not touch or handle the active electrode. Electrode dislodgement may occur. Always use the hemostasis valve crosser to assist insertion of the venous catheter through the introducer sheath. Insertion into introducer sheath without hemostasis valve crosser may damage electrode. Do not attempt to remove the hemostasis valve crosser located on the venous device. Device damage or fracture may occur. PRECAUTIONS: Care should be taken to avoid the presence of fluid on the ESU. Care should be taken during handling of the arterial and venous catheters in patients with implantable cardiac defibrillators or cardiac pacemakers to keep the distal 3 inches of the catheters at least 2 inches from the implanted defibrillator or pacemaker. Care should be taken to avoid attempting fistula creation in a heavily calcified location of a vessel as fistula may not be adequately formed. The safety and performance of this device has not been established for pediatric patients. If the device does not perform properly during the creation of the endovascular fistula it is possible that a fistula will not be created or there may be some vessel injury. Keep magnetic ends of catheters away from other metallic objects which may become attracted and collide with devices.

POTENTIAL ADVERSE EVENTS: The known potential risks related to the WavelinQ™ EndoAVF System and procedure, a standard AVF, and endovascular procedures may include, but are not limited to: aborted or longer procedure; additional procedures; bleeding, hematoma, or hemorrhage; bruising; burns; death; electrocution; embolism; failure to mature; fever; increased risk of congestive heart failure; infection; numbness, tingling, and/ or coolness; occlusion/stenosis; problem due to sedation or anesthesia; pseudoaneurysm; aneurysm; sepsis; steal syndrome or ischemia; swelling, irritation, or pain; thrombosis; toxic or allergic reaction; venous hypertension (arm swelling); vessel, nerve, or AVF damage or rupture; wound problem. Please consult product labels and instructions for use for all indications, contraindications, hazards, warnings and precautions.

0344

BD Switzerland Sarl, Terre Bonne Park – A4, Route De Crassier, 17, 1262 Eysins, Vaud. Switzerland.

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Issue 83 | September 2021

Guidelines 29

Perks and pitfalls: Making the most of social media as an IR “In interventional radiology, there is a strong online presence already—particularly on Twitter and LinkedIn, I would say—so it is a great way to market the practice, but also to network and meet people,” says Agnieszka Solberg, the founder of female advocacy organisation RadChicks, and a vascular and interventional radiologist at Catholic Health Initiatives (CHI) St Alexius Health in Bismarck, USA. Solberg spoke to Interventional News to outline how interventional radiologists (IRs) can utilise social media to the fullest while also avoiding some potential banana skins surrounding patient confidentiality and misinformation. DISCUSSING THE BENEFITS OF social media for IRs, Solberg continues: “It is especially great for trainees trying to get into the field—in particular for women and other underrepresented minorities hoping to get their name out there and meet some of the folks in interventional radiology. It is really nice to see people who look like you in the profession that you want to be in. I have found so many women in the field that are now my friends through social media—they have been an inspiration to me, and we have been an inspiration to others as well.” She goes on to note that it is particularly important for fields like interventional radiology, as well as neurosurgery, orthopaedics, and others, in

which there are not a lot of women and other minority groups, to embrace social media. Solberg admits that it can be challenging for physicians to do this through public posts and online

interactions, due to the restricting “social norms” that perceived professionalism has often dictated in the past. She adds, however, that physicians in this space are increasingly using social media in relation to their practice—and presenting themselves as more relatable in the process, while maintaining their lofty professional standards. She goes on to state that one way physicians can do this is by avoiding the most common pitfall associated with social media use, that being patient privacy issues. Online posts that include too much detail about a procedure or case may inadvertently identify patients, compromising their confidentiality, while physicians also need to be wary in certain instances about posting specific photographs or scans without gaining the patient’s consent to do so. “You have to be really careful about

There is so much misinformation out there at this time, so we really need more doctors and professors on these platforms to educate the public about certain things, and to help make it a more positive force.”

European Society of Hypertension position paper highlights renal denervation as a third option for hypertension management

have been consistently demonstrated across a wide spectrum of patients with uncontrolled HTN, in the absence and presence of prescribed antihypertensive medications. “RDN represents an evidence-based option to treat HTN, in addition to lifestyle changes and blood pressure lowering drugs. RDN expands therapeutic options to address the first objective of HTN treatment, to effectively reduce elevated blood pressure and achieve blood pressure targets,’’ said Konstantinos Tsioufis, professor of Cardiology at the University of Athens, Athens, Greece, and immediate past president of ESH. “Heightened cardiovascular risk such as evident organ damage or established disease like coronary artery disease or heart failure might be pointing towards treatment priority with RDN in hypertension. Additionally, patients who are unable or unwilling to take medication might be another RDN group, especially in the first stages of the hypertensive disease.” THE EUROPEAN SOCIETY OF Approximately half of individuals with hypertension Hypertension (ESH) presented an updated position do not meet guideline-directed blood pressure goals. paper on renal denervation (RDN) in a pre-ESH “Many patients with uncontrolled hypertension congress satellite symposium (10–11 September, Athens, struggle to adhere to lifelong drug therapy for a variety Greece). The paper was recently published in the of reasons and may look to other options that September issue of the Journal of Hypertension. complement traditional treatments,” said This position paper, written by an ESH expert Reinhold Kreutz, professor of Clinical Working Group, confirms that RDN is considered Pharmacology and Hypertension at a safe endovascular procedure without significant the Charité Universitaetsmedizin short-term or long-term adverse effects based on in Berlin, Germany and president data available up to three years. of ESH. “In light of the recent publication of several At the Athens pre-ESH meeting, second-generation sham-controlled clinical experts discussed various hypertensive trials, we thought it was important to provide Konstantinos Tsioufis profiles that could benefit from an updated position paper on RDN and its role RDN including those unable to in treating uncontrolled hypertension (HTN),” achieve blood pressure control said Roland Schmieder, professor of Internal despite application of guidelineMedicine, Nephrology and Hypertension at the recommended therapies, and those University Hospital Erlangen, Erlangen, Germany with high baseline cardiovascular risk and chairman of the ESH Working Group on or comorbidities or poor tolerance to interventional treatment of hypertension. medications. In recent sham-controlled randomised trials and “The shared decision-making registries, clinically favourable effects of RDN Reinhold Kreutz process is important and it is during

Agnieszka Solberg

when you post and how you post, and also what you post, because it may be interpreted as being sexist or racist even if that is not your intention,” Solberg says. “Always read your post twice, or even three times—sometimes I have somebody look over mine just to be sure—because, unfortunately, screenshots last forever.” “Like anything in the medical community, social media has the potential to be both positive and negative,” she concludes. “There is so much misinformation out there at this time, so we really need more doctors and professors on these platforms to educate the public about certain things, and to help make it a more positive force.”

File photo of renal denervation

that process that patients could select RDN as a treatment option in addition to lifestyle changes and blood pressure lowering drugs.

RDN represents an evidence-based option to treat HTN, in addition to lifestyle changes and blood pressure lowering drugs. RDN expands therapeutic options to address the first objective of HTN treatment, to effectively reduce elevated blood pressure and achieve blood pressure targets.”

Issue 83 | September 2021

Vascular Access 31

No working vein, no gain: New devices gather data on boosting vein enlargement to aid functional AVF creation With vein preservation and enlargement being a desired goal for functional fistula creation, recent clinical data in the form of a randomised controlled trial and a first-in-human study are emerging with two devices designed to promote enlargement. These data may spark the question: how do the results of these devices stack up against exercise to achieve the same aim? Or, can there be gain in vein without pain?

Improved rates of arteriovenous fistula creation and maintenance rest on the avilability of adequate, usable vein. Bottom left: Fist Assist FA-1 device, and bottom right; Amplifi device.

invasive EndoAVF procedures. These data could and should even drive Centers for Medicare & Medicaid Services (CMS) reimbursement as larger superficial veins will help improve outcomes, which drastically reduces the cost burden on patients, providers, and the entire healthcare system.”

P-FACT reports significant perforator vein dilation for improved EndoAVF success

The company also announced that data associated with the p-FACT cohort, a subset of the FACT trial, show clear evidence that the Fist Assist device dilates the perforator vein to enable creation of all types of AVFs, and to ensure the safety of the device in this patient population. “These are very important data as they not only show that the FA-1 device is safe, but also demonstrate that intermittent pneumatic pressure dilates superficial veins including, most importantly, the perforator vein needed for EndoAVF success. Condition of the perforator vein is critical for EndoAVF planning, and we can now show without a doubt that the Fist Assist FA-1 device can dilate that clinically important vein and have a key role in endoAVF consideration and planning,” said Tej Singh, chief executive officer and founder of Fist Assist Devices. FACT investigator John Lucas (Greenwood Leflore Hospital, Greenwood, USA) said:“Larger veins not only make vascular access surgery easier and more likely to succeed, but a larger, dilated perforator vein is essential for the EndoAVF to mature properly. Both EndoAVF technologies presently approved and available for treatment of end-stage renal disease utilise the perforator vein as a key component of the procedure. The statistically significant p-FACT data demonstrate that intermittent compression results in a larger perforator vein for stage four patients.”

Enrolment completion announced of first-in-human trial investigating Amplifi vein dilation system

FACT trial reports significant superficial arm vein dilation with intermittent compression

Fist Assist Devices has announced completion of the FACT trial, which evaluated the use of an intermittent pneumatic compression device, model FA-1, to promote vein dilation in patients with kidney disease. The trial’s results suggest the device could enable an increase in the creation of functional arteriovenous fistulas (AVFs) by enlarging superficial veins. The trial also demonstrates the device’s safety in this patient population, states a press release. “This is groundbreaking research that will drive efficiencies in the end-stage renal disease community as it really proves that intermittent compression enlarges superficial veins, and larger veins provide better surgical or [percutaneously created] EndoAVF options and outcomes” said John Ross, director of Regional Medical Center in Orangeburg, USA, and inductee in the American College of Surgeons and Academy of Master Surgeon Educators. The Fist Assist technology is patent protected and focused on developing an intermittent, external wearable pneumatic compression for arm massage and increased vein circulation in the USA, and increased forearm vein enhancement and AVF dilation/maturation in India, Canada, Europe, Australia, and New Zealand. “We are ecstatic to complete FACT and are very

thankful to all patients, physicians, and hospitals that worked to complete this trial during the COVID-19 pandemic, which was possible as the device is a patientcentric wearable in the home,” said Mary Hammes, primary investigator of the trial and associate professor of Medicine and director, Chronic Hemodialysis, at the University of Chicago, USA. “This is a landmark, global trial evaluating the effectiveness of the FA-1 intermittent compression device on presurgery, stage four chronic renal failure patients.” Patients were enrolled in three locations: The University of Chicago Medical Center, Chicago, USA; a medical clinic in Greenwood, USA, under the direction of John Lucas; and MS Ramaiah Medical Center, Bengaluru, India, under the direction of Sanjay Desai. On preliminary analysis, most enrolled patients showed statistically significant superficial vein dilation (p<0.05) without any safety concerns. A press release from the company states: This will be a gamechanger for the over 40 million stage four chronic kidney disease patients in the USA alone because larger veins will help ensure improved AVF creation, whether they are created surgically or by new EndoAVF procedures. Ross outlines the benefits of larger preprocedural veins: “With the recent focus of fistulas being created percutaneously through EndoAVF technology, these data are critically important as larger, presurgical veins will enable more patients to be candidates for the less

Artio Medical announced in late July that it has completed enrolment in its first-in-human study evaluating the Amplifi vein dilation system. In the study, five patients were treated by Adrian Ebner, head of the Cardiovascular Department at Sanatorio Italiano Hospital in Asunción, Paraguay. “I am very pleased with my initial experience using the Amplifi system,” Ebner said. “The device was simple to implant and well-tolerated by all patients. We observed significant vein enlargement in each enrolled patient and were able to successfully create AVFs in all patients after treatment, including patients who were poor candidates for AVF before treatment.” The Amplifi system is designed to stimulate arm vein enlargement in haemodialysis patients using rapid, non-pulsatile venous blood flow. After seven days of treatment, the device is removed during surgery to create an AVF, a press release from the company states. The Amplifi vein dilation system aims to make more haemodialysis patients eligible for AVF creation, increase fistula maturation success, reduce maturation time, and prolong the usable life of these fistulas. The Artio Medical website notes: “The system under development is a wearable, external blood pump with inflow and outflow catheters, and a controller with a rechargeable battery. The Amplifi system is used for up to 14 days and is removed during AVF creation.” “I am grateful to Dr Ebner and the entire team at Sanatorio Italiano who contributed to the success of this first-in-human study,” said F Nicholas Franano, president and CEO of Artio Medical. “The company looks forward to sharing data on these first five patients in the coming months and building upon this promising early clinical experience. We remain focused on delivering a much-needed solution to the millions of patients worldwide who need haemodialysis.”

September 2021 | Issue 83

32 Advertorial THIS ADVERTORIAL IS SPONSORED BY BD

Treating the dysfunctional vascular access: The expert’s low-pressure, low-dose approach Panagiotis Kitrou (Patras University Hospital, Patras, Greece) advocates a low-pressure, low-dose approach in order to address stenosis—the main culprit behind vascular access dysfunction.1 While high-pressure balloon angioplasty is currently considered the gold standard of treatment, the assistant professor of interventional radiology highlights associated issues of vascular wall trauma and restenosis. In the following case report, Kitrou proposes vessel preparation with the low-pressure Ultrascore™ focused force percutaneous transluminal angioplasty (PTA) balloon (BD) followed by angioplasty with the low-dose Lutonix™ 035 drug-coated balloon (DCB) PTA catheter (BD) as a way of addressing these two key issues and still successfully treating a dysfunctional vascular access.

s described by the latest Kidney Disease Outcomes Quality Initiative (KDOQI), a preferred way to treat a stenosis within the vascular access circuit, on a baseline level, is highpressure balloon angioplasty.2 However, as high pressures are frequently needed, up to 40atm, the vascular wall is traumatised due to barotrauma. This leads to a healing process which, at the same time, causes vessel restenosis. As an opinion, there are two key elements in this Sisyphean cycle of events. The first is to achieve an immediate lumen gain provoking the least trauma possible and the other is to slow down the inevitable process of restenosis. The scoring balloon is a relatively new technology proposed to treat vascular access stenosis at low pressures, an example of which is the Ultrascore focused force PTA balloon. The theory behind the technology is that when the balloon is inflated, it

pushes the wires against the vascular wall creating “cracks” in the stenotic tissue. In the case of vascular access stenosis, this could be very helpful confronting the fibrous part of the lesion. However, it should be noted there is inadequate evidence in the current KDOQI Guidelines to make a recommendation on the use of scoring balloons. Slowing down the process of restenosis is proposed to be achieved with the use of DCBs using paclitaxel

A final angiogram showed neither signs of residual stenosis nor significant flaps after scoring angioplasty.”

as the drug of choice.3 The Lutonix 035 DCB PTA catheter is a low-dose (2μg/mm2) paclitaxel-coated device. It has been investigated in several studies for the treatment of the dysfunctional vascular access. The Lutonix Panagiotis Kitrou Global AV registry, a multicentre, single-arm study by Karnabatidis et al, recruited 320 subjects from Europe and Asia, who underwent DCB angioplasty in 392 treatment areas. Access and lesion characteristics reflected real-world scenarios encountered by physicians in their everyday practice. The study included both arteriovenous fistulas (AVFs) and arteriovenous grafts (AVGs) in a 3:1 proportion. The study demonstrated a target lesion primary patency of 73.9% at six months.4

Case

The patient was a 52-year-old male on dialysis with a radiocephalic AVF for three years. He had recurrent stenosis that was treated with high-pressure balloons three times in the previous six months. Ultrasound examination revealed no significant stenosis in the upper part of the AVF, but a significant stenosis at the outflow region near the anastomosis and at the area of the anastomosis were observed (Figure 1). Volume flow measurements were 604.4ml/min at the level of the brachial artery and 259.5ml/min at the level of the radial artery. Access was gained from the cannulation zone, above the level of stenosis, in a retrograde approach and an angiogram was performed (Figure 2). Anastomosis was negotiated with a 0.018” wire and a 4Fr angled catheter. For vessel preparation, a 4x40mm Ultrascore focused force PTA balloon at the level of the anastomosis and a 7x60mm for the level of the outflow vein were used. Balloons were gradually inflated at the nominal pressure (6atm) for two minutes (Figure 3). Following scoring balloon angioplasty, the Lutonix 035 DCB PTA Continued overleaf

Figure 1. Ultrasonographic evaluation of vascular access and correlation with the anatomy. From bottom to top: stenosis at the anastomosis; stenosis at the segment following the anastomosis; segment without significant stenosis at the level of the cannulation zone.

Issue 83 | September 2021

Figure 2. Initial angiogram Figure 3. Angioplasty with the Ultrascore focused force PTA balloon at the level of the anastomosis (a) and outflow vein (b)

Advertorial 33

Figure 4. Lutonix 035 PTA DCB catheters used in the outflow vein stenosis and the anastomosis (a.b.c.). An image overlay shows sufficient overlap of devices and treated areas to avoid geographic miss (d).

Above: Ultrascore focused force PTA balloon

September 2021 | Issue 83

34 Advertorial THIS ADVERTORIAL IS SPONSORED BY BD catheters were used as an adjunctive treatment. It is of utmost importance to secure full coverage of the treated area with a DCB to avoid geographic miss. In cases where more than one balloon is needed, balloons should overlap to a minimum of 5mm for the same reason. In the current case, three DCBs were used (8x60mm, 7x40mm, and 5x40mm) to treat both lesions. As it appears in Figure 4, the whole treated areas were covered and sufficient overlap between the devices was performed. A final angiogram showed neither signs of residual stenosis nor significant flaps after scoring angioplasty. An interesting finding is the so-called “contrastdiluted phenomenon”. When comparing the initial with the final angiogram, contrast density is lower in the final angiogram (Figure 5). This could be because blood flow is higher in the latter case thus increasing the volume of blood mixed with contrast, which is also an indirect sign of successful angioplasty. Post-intervention ultrasound showed a volume flow of 1,030ml/min in the brachial artery providing an increase of 70.4% (Figure 6) while clinical examination revealed a palpable thrill.

Figure 5. Initial and final angiograms (left and right respectively)

Panagiotis Kitrou is an assistant professor of interventional radiology at Patras University Hospital in Patras, Greece. References 1. Diskin CJ. Novel insights into the pathobiology of the vascular access—do they translate into improved care? Blood Purif 2010;29(2):216–29. 2. Lok CE, Huber TS, Lee T, et al. KDOQI clinical practice guideline for vascular access: 2019 update. Am J Kidney Dis 2020;75(4 Suppl 2):S1– S164. 3. Kitrou PM, Katsanos K, Spyridonidis I, et al. Use of drug-coated balloons in dysfunctional arteriovenous dialysis access treatment: the effect of consecutive treatments on lesion patency. J Vasc Interv Radiol 2019;30(2):212–6. 4. Karnabatidis D, Kitrou PM, Ponce P, et al. A multicenter global registry of paclitaxel drug-coated balloon in dysfunctional arteriovenous fistulae and grafts: 6-month results. J Vasc Interv Radiol 2021;32(3):360–8 e2.

DISCLAIMER

Ultrascore™ Focused Force PTA Balloon INDICATIONS FOR USE:

The ULTRASCORE™ Focused Force PTA Balloon is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post dilatation of balloon expandable stents, self-expanding stents, and stent grafts in the peripheral vasculature. CONTRAINDICATIONS:

The ULTRASCORE™ Focused Force PTA Balloon is contraindicated: • Where there is the inability to cross the target lesion with a guidewire • For use in the coronary or neuro vasculature WARNINGS:

1) Contents supplied STERILE using ethylene oxide (EO). Non-Pyrogenic. Do not use if sterile barrier is opened or damaged. Do not reuse, reprocess or re-sterilize. Use the catheter prior to the “Use By” date specified on the package label. 2) This device has been designed for single use only. Reusing this medical device bears the risk of cross-patient contamination as medical devices – particularly those with long and small lumina, joints, and/or crevices between components – are difficult or impossible to clean once body fluids or tissues with potential pyrogenic or microbial contamination have had contact with the medical device for an indeterminable period of time. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications. 3) Do not resterilize. After resterilization, the sterility of the product is not guaranteed because of an indeterminable degree of potential pyrogenic or microbial contamination which may lead to infectious complications. Cleaning, reprocessing and/or resterilization of the present medical device increases the probability that the device will malfunction due to potential adverse effects on components that are influenced by thermal and/or mechanical changes. 4) To reduce the potential for vessel damage or difficulty in deflating, the inflated diameter and length of the balloon should approximate the diameter and length of the vessel just proximal and distal to the stenosis. 5) When the catheter is exposed to the vascular system, the location of the balloon should be confirmed while under high quality fluoroscopic observation. Do not advance or retract the catheter unless the balloon is fully deflated. If resistance is met during manipulation, determine the cause of the resistance before proceeding. Applying excessive force to the catheter can result in tip or catheter breakage, catheter kink, or balloon separation. 6) Do not exceed the RBP recommended for this device. Balloon rupture or difficulty in deflation may occur if the RBP rating is exceeded. To prevent over pressurization, use of a pressure monitoring device is recommended. 7) After use, this product may be a potential biohazard. Handle and dispose of in accordance with acceptable medical practices and applicable local, state and federal laws and regulations.

Figure 6. Volume flow increased by 70.4% following treatment. a. Volume flow prior to the treatment (604.4ml/ min). b. Post-treatment volume flow (1,030ml/min).

PRECAUTIONS:

1) Carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used. Do not use if product damage is evident. 2) The ULTRASCORE™ Focused Force PTA Balloon should only be used by physicians experienced in the performance of percutaneous transluminal angioplasty. 3) It is recommended to consider the use of anti-coagulants, anti-platelet agents, and/or vasodilators in conformance with the accepted standard of practice or institutional guidelines surrounding peripheral endovascular procedures. 4) For ULTRASCORE™ .014” guidewire sizes only, in order to activate the hydrophilic coating, wet the ULTRASCORE™ balloon and catheter with sterile saline or wipe the balloon catheter with sterile saline saturated gauze immediately prior to its insertion in the body. Do not wipe the balloon catheter with dry gauze. 5) The minimal acceptable sheath French size is printed on the package label. Do not attempt to pass the PTA catheter through a smaller size introducer sheath than indicated on the label. 6) Use the recommended balloon inflation medium (25% contrast medium/75% sterile saline solution). Never use air or other gaseous medium to inflate the balloon. 7) The ULTRASCORE™ Focused Force PTA Balloon should be used with caution for procedures involving calcified lesions, stents or synthetic vascular grafts due to the abrasive nature of these lesions. 8) Fully evacuate the balloon prior to withdrawing the system. Larger sizes of ULTRASCORE™ Focused Force PTA Balloons may exhibit slower deflation times. 9) If resistance is felt during post procedure withdrawal of the catheter through the introducer sheath, determine if contrast medium is trapped in the balloon with fluoroscopy. If contrast is present, push the balloon out of the sheath and then completely evacuate the contrast before proceeding to withdraw the balloon. 10) If resistance is still felt during post procedure withdrawal of the catheter, it is recommended to remove the balloon catheter and guidewire/introducer sheath as a single unit. 11) Do not continue to use the balloon catheter if the shaft has been bent or kinked. 12) For ULTRASCORE™ .014” guidewire sizes only, prior to re-insertion through the introducer sheath, re-activate the hydrophilic coating, and clean the balloon catheter by wiping the balloon catheter with sterile saline saturated gauze and rinsing with sterile saline. Do not wipe the balloon catheter with dry gauze. 13) GEOALIGN™ Marking System is designed to be used as an additional reference tool to accompany the interventionalist standard operation procedure. The use of fluoroscopic imaging is recommended following positioning of the catheter to the target lesion and prior to balloon deployment. POTENTIAL ADVERSE REACTIONS:

The complications that may result from a peripheral balloon dilatation procedure include: • Additional intervention • Allergic reaction to drugs or contrast medium • Aneurysm or pseudoaneurysm • Arrhythmias • Embolization • Hematoma • Hemorrhage, including bleeding at the puncture site • Hypotension/hypertension • Inflammation • Occlusion • Pain or tenderness • Pneumothorax or hemothorax • Sepsis/ infection • Shock • Short term hemodynamic deterioration • Stroke • Thrombosis • Vessel dissection, perforation, rupture, or spasm.

Lutonix™ 035 Drug Coated Balloon PTA Catheter INDICATIONS FOR USE:

The Lutonix® 035 Drug Coated Balloon Catheter is intended for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature and for the treatment of obstructive lesions and decreasing the incidence of restenosis. In addition, the Lutonix® 035 Drug Coated Balloon Catheter is intended for PTA of native dialysis fistulae or synthetic grafts, opening narrowing and immature fistulae, to improve blood flow, and decreasing the incidence of restenosis. CONTRAINDICATIONS:

The Lutonix® Catheter is contraindicated for use in: 1) Patients who cannot receive recommended anti-platelet and/ or anticoagulant therapy. 2) Women who are breastfeeding, pregnant or are intending to become pregnant or men intending to father children. It is unknown whether paclitaxel will be excreted in human milk and there is a potential for adverse reaction in nursing infants from paclitaxel exposure. 3) Pediatric patients. The safety and effectiveness of the Lutonix® Catheter in pediatric patients has not been established. 4) Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system. 5) This product should not be used in patients with known hypersensitivity to paclitaxel or structurally related compounds. WARNINGS:

1) Contents supplied STERILE using ethylene oxide (EO) process. Do not use if sterile barrier is damaged or opened prior to intended use. 2) Do not use if product damage is evident. 3) Do not use after the “Use By” date. 4 )The Lutonix® Catheter is for use in one patient only; do not reuse in another patient, reprocess or resterilize. Risks of reuse in another patient, reprocessing, or resterilization include: Compromising the structural integrity of the device and/ or device failure which, in turn, may result in patient injury, illness or death. Creating a risk of device contamination and/or patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to patient injury, illness or death. 5) Do not exceed the Rated Burst Pressure (RBP) recommended for this device. Balloon rupture may occur if the RBP rating is exceeded. To prevent over-pressurization, use of a pressure monitoring device is recommended. 6) Use the recommended balloon inflation medium of contrast and sterile saline (≤ 50% contrast). Never use air or any gaseous medium to inflate the balloon. 7) The safety and effectiveness of the Lutonix® Catheter have not been established for treatment in cerebral, carotid, coronary, renal vasculature or mesenteric arteries. PRECAUTIONS: General Precautions: 1) The safety and

effectiveness of using more than a maximum drug coating quantity of approximately 7.6 mg paclitaxel in a patient has not been clinically evaluated. 2) The Lutonix® Catheter should only be used by physicians trained in percutaneous interventional procedures. 3) Consideration should be given to the risks and benefits of use in patients with a history of non-controllable allergies to contrast agents. Use in Conjunction with Other Procedures:The safety and effectiveness of the Lutonix® Catheter used in conjunction with other drug eluting stents or drug coated balloons in

the same procedure or following treatment failure has not been evaluated. Device Handling Precautions: 1) Do not immerse the Lutonix® Catheter in a saline bath. Replace any device where the balloon has come into contact with fluids prior to use. 2) The coated balloon portion should be handled with dry sterile gloves whenever possible prior to use. 3) The balloon protector should stay in place during preparation of the Lutonix® Catheter and not be removed until just prior to placing over guidewire. 4) If difficulty is encountered while removing the balloon protector, a new Lutonix® Catheter should be utilized. Removing the balloon protector by force can cause a kink in the catheter shaft and lumen constriction may occur, affecting inflation/deflation of the balloon. Device Use/Procedure Precautions: 1) The Lutonix® Catheter should always be manipulated with adequate visualization technique when in the body. 2) Appropriate vessel preparation, such as predilatation, is recommended to achieve optimal DCB results. Successful pre-dilation is defined as of ≤ 30% residual stenosis. 3) Always advance and retrieve the Lutonix® Catheter under negative pressure. 4) After insertion, do not over-tighten the hemostatic adaptor (if used) around the Lutonix® Catheter shaft as lumen constriction may occur, affecting inflation/deflation of the balloon. 5) To ensure therapeutic drug delivery: Never inflate the Lutonix® Drug Coated Balloon prior to reaching the target lesion. The Lutonix® Catheter should be advanced to the target site as fast as possible (i.e. ≤ 30 seconds) and immediately inflated to appropriate pressure to ensure full wall apposition (balloon to vessel ratio of ≥ 1:1). If the deployment of the Lutonix® Catheter exceeds 3 minutes, the catheter requires replacement with a new unit. 1) Maintain balloon inflation for a minimum of 2 minutes (120 seconds). The balloon may remain inflated as long as is required by the standard of care to achieve a good angioplasty outcome 2) Do not continue to use the Lutonix® Catheter if the shaft has been bent or kinked. 3) Whenever possible, the Lutonix® Catheter should be the final treatment of the vessel; however, post-dilatation is allowed with another PTA catheter or the previously used Lutonix® catheter. Best outcomes are obtained when the final % diameter stenosis is 0 – 20%.Pre- and Post-Procedure Antiplatelet Regimen If applicable, dual antiplatelet therapy should be administered according to current medical standards pre-procedure and for a minimum of 4 weeks after the intervention. Prolonged antiplatelet therapy can be given at the discretion of the physician Please consult product labels and instructions for use for indications, contraindications, hazards, warnings, and precautions. © 2020 BD. BD, the BD logo, GeoAlign and Lutonix are trademarks of Becton, Dickinson and Company or an affiliate. All other trademarks are the property of their respective owners. All Rights Reserved.

2797

BD-36684

BD Switzerland Sarl, Route de Crassier 17, Business Park Terre-Bonne, Batiment A4 1262 Eysins Switzerland, Tel: +41 21 556 30 00. Fax: +41 44 722 5370

Issue 83 | September 2021

Study shows decreased mortality for patients with complex aortic aneurysms treated by F/BEVAR A recent study revealed that endovascular repair of complex aortic aneurysms using fenestrated and branched endografts provides a safe and effective alternative to open surgical repair, with the lowest ever reported mortality rate in this patient population. This is according to researchers at The University of Texas Health Science Center at Houston (UTHealth Houston, Houston, USA) and Memorial Hermann Heart and Vascular Institute Aortic Center (Houston, USA). THE STUDY, “MIDTERM OUTCOMES OF a prospective, non-randomised study to evaluate endovascular repair of complex aortic aneurysms using fenestrated-branched endografts,” led by senior author Gustavo Oderich (McGovern Medical School at UTHealth Houston), was published in the September

Complex Aortic Repair 35

21% 1%

risk of mortality at 30 days

risk of mortality with open surgery...

compared to ...as seen in patients treated by open surgical repair in the USA

The improvement in mortality also compares favourably to mortality rates of open repair in large aortic centres, which range between

9-17%

14,000

2021 Annals of Surgery. The study focused on treatment of complex aortic aneurysms, including pararenal and thoracoabdominal aortic aneurysms, which affect the aorta and the branches to the kidneys and intestines. These aneurysms are associated with high risk of rupture and death. While most aortic aneurysms are not associated with symptoms, if undiagnosed, progressive enlargement can lead to rupture with a high fatality rate. The researchers report that endovascular repair using fenestrated and branched endografts was associated with a 1% risk of mortality at 30 days, which compares to a mortality of 21% in a recent study of more than 14,000 patients treated by open surgical repair in the USA. The improvement in mortality also compares favourably to mortality rates of open repair in large aortic centres, which range between 9–17%. “When we began the study, we had no idea the rate of mortality would be so much lower than the historical results of open surgical repair,” Oderich said in a press release. The study, which included 430 patients with an average age of 74, also showed better outcomes

regarding major adverse events, including paralysis and paraplegia caused by spinal cord injury. Spinal cord injury affected 6% of patients enrolled in the fenestrated or branched endovascular aneurysm repair (F/BEVAR) study, which is similar to contemporary open surgical studies in which the rate of spinal cord injuries reported was 5–10%. This research is supported by Cook Medical and GE Healthcare, which provided funding for research coordinator support.

When we began the study, we had no idea the rate of mortality would be so much lower than the historical results of open surgical repair.”

COLOR BRINGS NEW CLARITY Visit us virtually at CIRSE 2021 or at ebooth.ziehm.com As an innovation leader, we are committed to our mission of setting new technology standards. We are moving ahead into a colorful future in mobile C-arm imaging and welcome our new efficiency-boosting feature, now integrated into our comprehensive set of software functionalities. Enhanced Vessel Visualization Colored markings of vessels and side branches for improved detection and differentiation during complex vascular procedures. www.ziehm.com/clarity

ALWAYS

AHEAD

September 2021 | Issue 83

36 CX Aortic Vienna

Aortic Event

CX Aortic Vienna 2021 programme Bringing together the cardiac aortic, vascular and endovascular worlds, and spanning the aortic valve to the iliac arteries, the CX Aortic Vienna 2021 programme will broadcast globally. The CME-accredited meeting runs from 5 to 7 October. Register now at cxsymposium.com/cxaortic/cx-aortic-vienna/registration/ Day 1:

Day 2:

Day 3:

Tuesday 5th October

Wednesday 6th October

Thursday 7th October

Time: 11:00–18:00 London time (BST)

CX Aortic arch challenges. Is Frozen Elephant Trunk (FET) still needed? Time: 11:00–12:00 London time (BST)

Thoraco-Abdominal Aortic Aneurysm (TAAA) Reconstruction & How To Do It (HTDI) Professor Roberto Chiesa and team Time: 11:00–12:00 London time (BST)

Training & Teamwork for Optimal Aortic Patient Outcomes Time: 11:00–12:00 London time (BST)

Best of CX and Prize abstracts Time: 12:00–12:30 London time (BST) CX Aortic arch challenges. Is Frozen Elephant Trunk (FET) still needed? (continued) Time: 12:30–12:50 London time (BST) TAVI & CX Paediatric Cardiac Aortic Challenges Time: 12:50–13:30 London time (BST) Best of CX and Prize abstracts Time: 13:30–14:00 London time (BST) CX Juxtarenal Aortic Neck Challenges Time: 14:00–15:00 London time (BST) Industry Satellite: How to approach safely complex AAA with off-the-shelf solutions Time: 15:00–15:30 London time (BST) CX Arch Aortic Stroke from Thoracic Endovascular Procedures (STEP) Time: 15:30–16:20 London time (BST)

Best of CX and Prize abstracts Time: 12:00–12:30 London time (BST) Thoraco-Abdominal Aortic Aneurysm (TAAA) Reconstruction (continued) Time: 12:30–13:30 London time (BST) Industry Satellite: Five years of proven durability with Zenith Alpha thoracic Low-profile system Time: 13:30–14:00 London time (BST) Thoraco-Abdominal Aortic Aneurysm (TAAA) Reconstruction (continued) Time: 14:00–14:40 London time (BST) Reduction of Radiation Challenges Time: 14:40–15:00 London time (BST) Key FORS moments discussed Time: 15:00–15:30 London time (BST) Reduction of Radiation Challenges (continued) Time: 15:30–15:50 London time (BST)

Best of CX and prize abstracts Time: 12:00–12:30 London time (BST) CX Aortic Arch & Thoracoabdominal Techniques Time: 12:30–13:30 London time (BST) Best of CX and prize abstracts Time: 13:30–14:00 London time (BST) CX Aortic Arch & Thoracoabdominal Techniques (continued) Time: 14:00–15:00 London time (BST) Best of CX and prize abstracts Time: 15:00–15:30 London time (BST) Best of Italian Abstracts and Society of Vascular and Endovascular Surgery (SICVE) Time: 15:30–16:00 London time (BST) Best of Italian Abstracts and Society of Vascular and Endovascular Surgery (SICVE) Time: 16:00–16:30 London time (BST)

CX Aortic Dissection Challenges Time: 16:20–16:30 London time (BST)

CX EVAR Durability Questioned Time: 15:50–16:30 London time (BST)

Best of Austrian Society of Vascular Surgery (OGG) Abstracts Time: 16:30–17:00 London time (BST)

Industry Satellite: Endovascular treatment of Type B aortic dissection Time: 16:30–17:00 London time (BST)

The need for Personalised Solutions in Aortic Repair Time: 16:30–17:00 London time (BST)

Best of German Society for Vascular Surgery and Vascular Medicine (DGG) Time: 17:00–17:30 London time (BST)

CX Aortic Dissection Challenges (continued) Time: 17:00–18:00 London time (BST)

CX EVAR Durability Questioned (continued) Time: 17:00–17:20 London time (BST)

Best of Swiss Society for Vascular Surgery (SGG) Time: 17:30–18:00 London time (BST)

Ruptured Abdominal Aortic Aneurysm (AAA) Time: 17:12–18:00 London time (BST)

Issue 83 | September 2021

CX Aortic Vienna 37

CX AORTIC VIENNA

CX Aortic Vienna 2021 to address key questions in the field Discussing the balance of open and endovascular aortic care with Gustavo Oderich Gustavo Oderich (University of Texas Health Science Center, Houston, Texas) talks about the future of Zone 0 treatment, describing it as “the last frontier” to be taken over by endovascular means. Oderich stresses the importance of multidisciplinary collaboration with cardiac and interventional cardiology specialists, particularly for Zone 0 procedures.

What is the future of endovascular and open techniques in Zone 0?

Zone 0 is the last frontier and I do not underestimate it. I have experienced three of the four possible major complications that can happen in Zone 0: wire perforation of a ventricle; retrograde type A; and injury of the aortic valve. I have not yet seen coverage of the coronary arteries, but I know others who have done so. This indicates that we have to be careful with that as well. Zone 0 treatment is evolving fast with the advent of transcatheter aortic valve replacement (TAVR) and arch devices, and I am sure at some point we will all be doing endovascular Bentall procedures, but there is still a way to go.

What are your thoughts on the Endo-Bentall procedure? The major challenge with this procedure is going to be stenting the coronary arteries and assuring nearly 100% technical success and patency, given the high stakes of a failed procedure. The coronaries are very small vessels prone to spasm; therefore, we typically have

to work with 0.014 or 0.018 systems. The stent graft technology is just not there yet. The other challenge is that current percutaneous valves are designed for stenotic disease and not for normal valves or valves with insufficiency, so the fixation of the device is going to be an issue. Again, the technology is not there yet. We have to focus on creating a device that is not going to migrate.

Is multidisciplinary collaboration necessary for complex endovascular procedures?

I think for Zone 0 you should have a multidisciplinary team that involves cardiac surgeons, along with vascular surgeons, cardiovascular anaesthesia and also interventional cardiologists, because we know things are going to move towards the aortic valve, towards the coronaries, and no single specialty has the expertise to deal with all the potential complications.

Is there a place for an aorticonly meeting to consider total aortic management? Absolutely, and I think that CX Aortic Vienna is a great example of such a meeting. It has an excellent group of people putting together the programme, addressing the most pertinent questions to be answered in the aortic field. Also, we know multidisciplinary involvement is important, and CX Aortic Vienna is an opportunity in a more concise meeting to bring together all specialties to talk about aortic disease.

Pointing to the future of aortic care with Tilo Kölbel

Advocating for multidisciplinary aortic teams with Joseph Coselli

Tilo Kölbel (German Aortic Center and the University Heart Center, Hamburg, Germany) speaks about the excitement surrounding his edited case demonstrating a “Branched endovascular repair of Type IV thoracoabdominal aortic aneurysm using FORS [Fiber Optic RealShape; Philips] laser light guidance”. Kölbel predicts this “disruptive” new technology will change imaging during the management of aortic disease in the future.

Joseph Coselli (Baylor College of Medicine, Houston, USA) talks about the pioneers of the aortic field and future of aortic practice. Coselli advocates for the “need not to have silos” but instead “teams” involving interventional radiology, cardiac, vascular and endovascular specialists to promote a shared growth throughout the field.

What are you most looking forward to at CX Aortic Vienna 2021?

I am most excited about the discussion of open or endovascular aortic arch repair. There will be debate between open cardiac surgeons and endovascular surgeons in order to determine which patients and which anatomies should be treated with endovascular therapies. I very much look forward to discussing this with open surgeons as I am a strong proponent of the endovascular techniques.

Is it justified to have a meeting entirely dedicated to aortic care?

To focus a whole meeting on aortic care is a very good idea because it allows aortic specialists to come together and to focus on this area. I see in other larger, more general, meetings that it is more difficult to get together as aortic experts. We are usually distracted by other topics as only a few of us do aortic procedures exclusively.

Why should viewers tune in to your edited case, “Branched endovascular repair of Type IV thoracoabdominal aortic aneurysm using FORS laser light guidance”? I think everybody who wants to see the aortic repair of the future should view this case. FORS offers a radiation-free technology, giving more and better information on the 3D position of our instruments within the patient’s body, so it is endovascular repair in colour and in 3D—that is what I believe endovascular aortic repair will look like in most centres in five to 10 years.

I speak to you from the perspective of having been trained by Michael DeBakey, having had a lifelong personal friendship with Den Cooley, and having spent seven years working with Stanley Crawford, which gave me an opportunity to become very familiar with the thoracoabdominal aorta and vascular surgery across the full spectrum. When we look back at these pioneers in our speciality, we

One of the things that has become very clear to me over the years is that we need not to have silos but we need to have teams.” can see that they did procedures and techniques that they did not do in their training. As they gained knowledge, they reinforced how important it was to share that knowledge, to share their experience, and to teach others. One of the things that has become very clear to me over the years is that we need not to have silos but we need to have teams, which need to include interventional radiologists, radiologists, cardiologists, endovascular specialists, open aortic and vascular teams, etc. It is important we bring together the knowledge of these teams in order to treat the individual patient.

Issue 83 | September 2021

Market Watch 39

Product News the tissue, leading to an effective and durable outcome. The 200mm and 250mm IN.PACT Admiral DCBs received FDA approval in May of 2018.

IN.PACT Admiral drug-coated balloons

Medtronic obtains CE mark to launch 200mm and 250mm IN.PACT Admiral DCBs Medtronic has announced the European launch of the 200mm and 250mm IN.PACT Admiral drug-coated balloons (DCBs) following CE mark approval. The product is intended to treat long complex femoropopliteal lesions efficiently in patients with peripheral arterial disease (PAD). The 200mm and 250mm IN.PACT Admiral DCBs enable physicians to treat longer lesions using a single DCB instead of multiple DCBs, a press release notes. Thomas Zeller, director of the Department of Angiology at Universitaets-Herzzentrum, FreiburgBad Krozingen, Germany, performed the first case using the new sizes of the IN.PACT Admiral DCB in Europe. He stated: “Patients with SFA [superficial femoral artery] disease often present with longer and more complex lesions as time goes on, which makes it challenging to effectively treat the entire segment. We know the IN.PACT Admiral DCB is effective in providing durable results, and now, with the longer sizes, it is a more efficient treatment option for these difficult-to-treat lesions. Using the new sizes of the IN.PACT Admiral DCB could potentially lead to saving both time and money by using one balloon instead of multiple balloons.”

About the IN.PACT Admiral DCB

A company release outlines that the IN.PACT Admiral DCB is a clinically established, primary endovascular therapy tool, which has been shown to provide durable, consistent and safe outcomes across multiple clinical trials, as well as across complex patient and lesion types. “With more than 3,500 patients enrolled in 21 clinical studies and 600,000+ patients treated worldwide, the IN.PACT Admiral DCB is the preferred DCB for treatment of femoropopliteal disease—allowing reduced interventions and preserving future treatment options. A DCB’s primary mode of action is physical dilatation of the vessel lumen by percutaneous transluminal angioplasty (PTA), followed by the delivery of paclitaxel. The unique formulation of IN.PACT Admiral DCB with its drug dose, excipient and crystallinity, provides sustained drug residence in

Argon Medical Devices reveals launch of minimally invasive drainage catheter

Argon Medical Devices has announced the commercial launch of Skater miniloop drainage catheters in the USA and the European Union. The Skater mini-loop is a drainage catheter placed through the skin using imaging guidance as a minimally invasive way to remove or drain an unwanted fluid collection. The device, an expansion of Argon’s Skater allpurpose and nephrostomy drainage portfolio, uses a 40% smaller loop to help secure the catheter and drain fluid from smaller cavities, a press release states. “The Skater mini-loop drainage catheter is easily inserted and forms a tight loop formation to prevent drainage occlusion. Unlike other drainage catheters in the class, Skater mini-loop is compatible with alcohol and has durability to resist kinking,” said Sujoy Menon (Newark Beth Israel Medical Center, Newark, USA), one of the first physicians in the USA to use the device. Argon Medical Devices has introduced several new devices in the biopsy, drainage, and vascular therapy segments in 2020, and is planning on expanding its product list aimed at facilitating interventional vascular and oncology procedures in 2021, it adds.

FDA approves expanded PAD indication for Xarelto plus aspirin to include patients after lower extremity revascularisation

The Janssen Pharmaceutical Companies of Johnson & Johnson has announced that the US Food and Drug Administration (FDA) has approved an expanded peripheral arterial disease (PAD) indication for the Xarelto (rivaroxaban) vascular dose (2.5mg twice daily plus aspirin 100mg once daily) to include patients following recent lower-extremity revascularisation (LER) due to symptomatic PAD. The approval is based on data from the Phase III VOYAGER PAD study. According to a press release, Xarelto is now the first and only therapy indicated to help reduce the risks of major cardiovascular events in patients with coronary artery disease (CAD) and major thrombotic vascular events, such as myocardial infarction, ischaemic stroke, acute limb ischaemia, and major amputation of a vascular aetiology, in patients with PAD, including patients who have recently undergone LER due to symptomatic PAD. “For more than 20 years, many

physicians have used dual antiplatelet therapy after lower extremity revascularisation due to symptomatic PAD, with limited data to support efficacy and safety in this setting. Now, the VOYAGER PAD and COMPASS clinical studies have demonstrated the utility of dual pathway inhibition in targeting both platelets and thrombin in patients with PAD. These data provide a new mechanism of treatment using an evidence-based strategy for this vulnerable population,” said Marc P Bonaca (University of Colorado Anschutz Medical Campus, Aurora, USA). “This FDA approval of rivaroxaban plus aspirin is a major advancement for PAD management and sets the stage to evolve the current standard of care for patients with PAD.”

Azur vascular plug

Terumo introduces Azur vascular plug and PG Pro peripheral microcatheter embolization system in Europe

Terumo Medical Corporation announced the introduction of its Azur vascular plug in July. The addition to Terumo’s embolization portfolio is indicated for use to reduce or block the rate of blood flow in arteries of the peripheral vasculature. A Terumo press release details that the Azur vascular plug comes in sizes to treat arterial anatomy ranging from 2.5–8mm, with a short deployment length for increased precision. Features include a conformable nitinol braid and an expanded polytetrafluoroethylene (ePTFE) and polyethylene terephthalate (PET) inner composite membrane to facilitate mechanical occlusion. Another key element in the plug’s design is its “advanced, predictable” detachment mechanism, the statement reads, which allows for “immediate and reliable deployment with the push of a button”. The launch of the Azur vascular plug is complemented by the introduction of the PG Pro peripheral microcatheter, which is indicated for the peripheral vasculature for the infusion of diagnostic and therapeutic agents. The PG Pro microcatheter is designed specifically to deliver all three sizes of the Azur vascular plug. It comes in radial lengths up to 165cm and a 1,200 PSI rating for clearer fluoroscopic imaging. Both are currently only available in the USA.

Philips gets FDA Breakthrough Device designation for laser-assisted IVC filter removal device Royal Philips has announced the US Food and Drug Administration (FDA) has granted Breakthrough Device

designation for a laser-assisted inferior vena cava (IVC) filter removal device. The proposed device is intended for ablating tissue to remove an IVC filter when previous methods of removal have failed. The failure rate for IVC filter removal is high and limited options for removal exist if the filter has become difficult to remove. Advanced retrieval tools and techniques are required if the IVC filter becomes embedded in the vasculature. Physicians have very few tools to remove the filter when this happens and there are no FDA-approved devices for this type of advanced removal. Two independent and prospective clinical studies have demonstrated that laser-assisted retrieval was 96–99% effective with a major adverse event rate of 0.7–2%, a Philips press release reports. “Laser-assisted filter retrieval may be a critical tool for the safe retrieval of filters with extended implantation times,” said Kush R Desai, associate professor of Radiology, Surgery, and Medicine, and director of Deep Venous Interventions at Northwestern University Feinberg School of Medicine (Chicago, USA). “Breakthrough Device designation reflects the potential impact that this technology could have on countless patients where this technology can be applied to safely retrieve filters by an expert physician, thereby reducing their risk of significant filter-related complications.”

Embosoft microspheres

Scitech Medical’s Embosoft microspheres receive CE mark approval for vascular embolization

Scitech Medical has announced that it has received CE mark approval for the Embosoft microspheres for use in vascular embolization of hypervascular tumours, symptomatic uterine fibroids and prostatic arteries to relieve symptoms related to benign prostatic hyperplasia, as well as for haemostatic embolization. According to the company, Embosoft’s high rate of viscoelasticity and its hydrophilic surface allow a selective distal embolization that is safe and effective. Embosoft microspheres are composed of the company’s Polifit 70 material, which guarantees a welldefined spherical shape and a superior compressibility rate. Because of these characteristics, it is possible to reduce approximately 40% of its size during its delivery and it will return to the initial spherical shape without fragmentation or deformation in the target vessel, a company release states.

Issue 83 | September 2021

Market Watch 41

Clinical News

EkoSonic endovascular system

Boston Scientific begins randomised controlled trial for the EkoSonic endovascular system

Boston Scientific has started enrolment in the HI-PEITHO clinical trial, a collaborative research study with the Pulmonary Embolism Response Team (PERT) Consortium and the University Medical Center of the Johannes Gutenberg University of Mainz (Mainz, Germany) comparing use of the EkoSonic endovascular system (Ekos) in combination with anticoagulation to anticoagulation alone for the treatment of acute, intermediate-high-risk pulmonary embolism (PE). The Ekos system uses ultrasound energy in combination with a thrombolytic drug to dissolve blood clots and restore blood flow in patients with PE and peripheral arterial occlusions. According to a company press release, the ultrasound technology used by the Ekos system accelerates thrombolysis, minimising the time it takes to treat a patient and lowering the necessary thrombolytic dose, which can result in optimised outcomes and a lower risk of bleeding. The randomised HI-PEITHO trial will enrol up to 544 patients with confirmed acute, intermediate-high-risk PE at as many as 65 sites in the USA and Europe. The trial, which will follow patients for one year, will assess whether treatment with the Ekos system in combination with anticoagulation is associated with a significant reduction in adverse events compared to anticoagulation alone, within seven days of randomisation. The composite primary endpoint is defined as PE-related mortality, cardiorespiratory decompensation or collapse, and non-fatal symptomatic and objectively confirmed recurrence of PE.

First patient enrolled in Shape Memory Medical’s AAASHAPE Netherlands study Shape Memory Medical has announced the initiation of AAA-SHAPE Netherlands, the company’s prospective, multicentre early feasibility study of the Impede-FX RapidFill device when used for abdominal aortic aneurysm (AAA) sac management during elective endovascular aneurysm repair (EVAR).

The Dutch study’s first procedure was performed by Michel Reijnen, vascular surgeon at Rijnstate Hospital in Arnhem, The Netherlands. The study will enrol up to 15 patients across three centres in The Netherlands, contributing to the AAA-SHAPE safety study, which is also currently enrolling up to 15 patients in Auckland, New Zealand. The Impede-FX RapidFill device contains five Impede-FX, 12mm embolization plugs preloaded into a single delivery introducer for fast and efficient delivery of the embolic material. This high-volume platform incorporates the novel Shape Memory Polymer, a porous, embolic scaffold that is crimped for catheter delivery and selfexpands upon contact with blood for rapid conversion to organised thrombus. Preclinical and clinical studies have shown that Shape Memory Polymer offers effective and predictable space filling, stable clot formation for sac embolization, and progressive healing as the material biodegrades. “We are very pleased to be working together with colleagues from The Netherlands to add to our growing experience with AAA-SHAPE,” said Andrew Holden, interventional radiologist at Auckland City Hospital in Auckland, New Zealand. “Our preliminary experience with AAASHAPE has been very encouraging, and the first few patients have shown a reduction in AAA sac diameter at early follow-up,” continued Holden.

or are not candidates for both surgery and stereotactic body radiation therapy (SBRT). The findings were released at a latebreaking presentation at the European Respiratory Society International Congress (September 5, 2021; virtual). Kelvin Lau, a consultant thoracic surgeon at St. Bartholomew’s Hospital (London, UK) and a principal investigator for the NAVABLATE study, said: “Patients with malignant lesions in the lung often have limited therapy options due to lesion locations, comorbidities, and treatment side effects. “The results from the NAVABLATE study explore the potential benefit of a more individualised treatment for patients and offer a new option for surgeons and physicians to provide a minimally invasive, localised treatment of malignant lesions in the lung.” NAVABLATE is a prospective, multicentre study that enrolled 30 patients in the UK and Hong Kong to characterise the safety and performance of the CE Marked Emprint Ablation Catheter Kit. All patients underwent a bronchoscopic ablation procedure using the Emprint Ablation Catheter Kit and were followed for one-month post procedure. Ablation using the Emprint Ablation Catheter Kit achieved 100% technical success in all 30 patients immediately post-procedure. One-month imaging showed ‘satisfactory’ ablation of the nodule in 100% of subjects. The composite rate of adverse events related to the Emprint Ablation Catheter Kit was 3.3% (one patient with mild haemoptysis). There were no deaths or pneumothoraces. The Emprint Ablation Catheter Kit received Breakthrough Device Designation status from the US Food and Drug Administration (FDA) in April 2021. This device is not approved or cleared by FDA and is not available for sale in the US.

R3 Vascular reports the initiation of its first-in-human clinical study

Emprint ablation catheter

Medtronic’s NAVABLATE study demonstrates feasibility of bronchoscopic microwave ablation for certain patients with malignant lung nodules

Recently released clinical data from the NAVABLATE study have shown that microwave ablation used bronchoscopically—with the Emprint Ablation Catheter Kit with Thermosphere Technology (Medtronic) in conjunction with the firm’s electromagnetic navigation bronchoscopy system—is an option for primary and oligometastatic malignant lung nodules in patients who decline

R3 Vascular has reported the successful initiation of its first-in-human clinical study evaluating the technical and clinical performance of the R3 Vascular Magnitude bioresorbable sirolimuseluting scaffold (BRS) in patients suffering of chronic limb-threatening ischaemia (CLTI) due to occlusive below-the-knee (BTK) arterial disease. A press release details that the R3 Vascular platform incorporates an innovative scaffold design and bioresorbable polymer technology resulting in biomechanical performance comparable to metallic stents. At a 98-micron strut thickness across all its usable range of diameters, the Magnitude BRS device is the thinnest BRS ever tested in this clinical setting, the release adds. “In this early clinical experience, we successfully tested the deliverability and mechanical performance of the Magnitude BRS. Post-procedural angiographic and duplex ultrasound

data confirm the mechanical properties and ‘stent-like’ results of the Magnitude BRS device in presence of a highdisease burden. We are looking forward to expanding the patient population cohort and following the clinical results over time,” said Marianne Brodman (Medical University of Graz, Graz, Austria).

Selution SLR drug-eluting balloon

Medalliance reports PRISTINE registry with sirolimus drug-eluting balloon completes enrolment MedAlliance has announced completion of patient enrolment in the PRISTINE clinical trial with the Selution SLR 018 drug-eluting balloon (DEB) for the treatment of patients with below-theknee (BTK) disease. The objective of the prospective PRISTINE trial is to evaluate the safety and efficacy of the Selution SLR sirolimus DEB in the treatment of infrainguinal occlusive lesions (TASC C and D) in patients with chronic limbthreatening ischaemia in 75 patients over 12 months at Singapore General Hospital in Singapore. PRISTINE is a follow-up registry to the PRESTIGE trial. The 12-month data from PRESTIGE were presented at LINC 2021 (The Leipzig Interventional Course, 25–29 January, online), showing sustained benefits up to one year. Eighteen-month data is to be presented at VIVA 2021 (Vascular InterVentional Advances; 4–7 October, Las Vegas, USA), where it is anticipated that these benefits will be further sustained. A similar outcome benefit is expected from PRISTINE in a larger real-world population. “One of the important things to note is that we had few exclusion criteria, unlike many of the randomised controlled trials using drug-coated balloons in the peripheral vasculature, and the data represent real-life lesions that we face every day as vascular specialists in Singapore”, said lead investigator Tjun Yip Tang (Singapore General Hospital, Singapore). “PRISTINE will offer further insight, leveraging on our initial experience with the PRESTIGE trial, into whether this sirolimus-eluting balloon will become an established device in our angioplasty armamentarium to fight the neointimal hyperplasia effect and restenosis phenomenon that lead to a significant number of clinically driven target lesion revascularisations in the BTK arteries, in this frail and challenging cohort of patients, whose ischaemic foot wounds are difficult to heal.”

September 2021 | Issue 83

42 Market Watch

names Tara Graham as new president

Industry News RenovoRx gets US FDA nod for RenovoCath delivery system

The RenovoCath Delivery System is the device component of the company’s initial product, RenovoGem. This drug/ device combination used in RenovoRx’s Trans-Arterial Micro-Perfusion (RenovoTAMP) therapy platform is a dual-balloon infusion catheter delivering chemotherapy directly to tumours via arteries. This new design provides more targeted delivery of therapy which the company believes can translate into more effective treatment with fewer side effects. RenovoRx received its initial 510(k) for the RenovoCath delivery system in 2014. “Our novel RenovoTAMP therapy platform isolates the region of disease enabling delivery of the optimal dose of targeted chemotherapy to the tumour location,” said Shaun Bagai, chief executive Officer at RenovoRx. “We believe this new design cleared through the FDA 510(k) process will further improve RenovoTAMP’s targeted delivery. Our focus is maximising patient survival while minimising sideeffects for cancer patients.”

RenovoTAMP is the Company’s novel therapy platform designed to deliver well-established chemotherapeutic agents for localised treatment of solid cancer tumours. It is under clinical investigation for increasing survival and improving quality of life. This platform technology may enable physicians to isolate the anatomy and micro-perfuse targeted tissue with small molecule chemotherapy. As of August 15, 2021, the Phase 3 TIGeR-PaC clinical trial — a randomised study utilising the RenovoTAMP platform to evaluate RenovoGem — reached 44% patient enrolment for the treatment of pancreatic cancer. TIGeR-PaC is currently enrolling locally advanced, pancreatic cancer patients. In clinical studies conducted to date, chemotherapy delivered with the RenovoTAMP platform was associated with more than half the patients living more than two years. Pancreatic cancer patients treated standard-of-care typically live 12 to 15 months after diagnosis.

Canadian Association for Interventional Radiology

Tara Graham (Trillium Health Partners, Toronto, Canada) has become the new president of the Canadian Association for Interventional Radiology (CAIR), assuming the new role at the board’s meeting on June 14th, 2021. Amol Mujoomdar (London Health Sciences Centre, London, Canada), the outgoing president, will continue to serve on the CAIR executive board in the role of past president replacing Jason Wong (University of Calgary, Calgary, Canada), who will transition into a director position. Alessandra Cassano-Bailey (Health Sciences Centre in Winnipeg, Winnipeg, Canada) will be assuming the role of vice president; and David Valenti (McGill University Health Center, Montreal, Canada) will replace Darren Klass (Vancouver Coastal Health, Vancouver, Canada) as the new CAIR board secretary-treasurer.

Abbott expands peripheral vascular offerings with acquisition of Walk Vascular

Abbott has announced that it has acquired Walk Vascular, a commercialstage medical device company with a minimally invasive mechanical aspiration thrombectomy system designed to remove peripheral blood clots. Walk Vascular’s peripheral thrombectomy systems will be

incorporated into Abbott’s existing endovascular product portfolio. Financial terms were not disclosed. “The acquisition of Walk Vascular fits well into our leading vascular device offerings and further drives Abbott’s ability to provide one-of-akind endovascular therapy solutions to improve patient care,” said Julie Tyler, senior vice president of Abbott’s vascular business. “Walk Vascular’s technology provides physicians with tools to efficiently remove dangerous clots from blood vessels to improve patient care.” Walk Vascular’s Jeti peripheral thrombectomy system and Jeti AIO (All In One) peripheral thrombectomy system are aspiration systems for the removal of thrombus. The Jeti systems are designed to break-up and remove clots from the peripheral vascular system while reducing the risk of dislodged clots. The systems are backed by real-world clinical experiences, and Walk is currently enrolling up to 250 patients in the USA and Europe in the Jeti Registry.

Jeti thrombectomy system

Calendar of events Please be advised that the events listed opposite, because of COVID-19, are subject to change. Please check the relevant website for further details as the event may be cancelled, postponed, or become a virtual event.

25–28 August 2021 CIRSE SUMMIT Online

16–20 November 2021 VEITHsymposium Orlando, USA

31 January–3 February 2022 Leipzig Interventional Course (LINC) Leipzig, Germany & virtual

www.cirse.org

www.veithsymposium.org

4–7 October 2021 Vascular InterVentional Advances (VIVA) Las Vegas, USA

16–19 January 2022 International Symposium on Endovascular Therapy (ISET) Hollywood, USA

www.vivaphysicians.org

www.iset.org

5–7 October 2021 CX Aortic Vienna Broadcast

24–25 January 2022 MIO Live symposium Rome, Italy

www.cxsymposium.com/cxaortic

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

www.leipzig-interventionalcourse.com

3–7 February 2022 Society of Interventional Oncology (SIO) San Francisco, USA www.sio-central.org/SIO2022

3–7 February 2022 Canadian Association for Interventional Radiology (CAIR) Grand Slam and Catastrophes Whistler, Canada www.cairweb.ca

2–6 March 2022 The European Congress of Radiology (ECR) Vienna, Austria www.myesr.org/congress/ecr2022

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