Interventional News Issue 77—March 2020 US Edition

March 2020 | Issue 77

International accreditation scheme “brings IO into the mainstream” The newly established International Accreditation System for Interventional Oncology Services (IASIOS) gives medical facilities the opportunity to receive credentials for their interventional oncology (IO) service line. Developed by the Cardiovascular and Interventional Radiological Society of Europe (CIRSE), IASIOS focuses on the entire patient pathway, and as such has been heralded as a way of recognising that interventional oncologists are “clinicians, not just technicians”. Andreas ‘Andy’ Adam (Guy’s and St Thomas’ NHS Foundation Trust, London, UK) tells Interventional News that the project “will help establish IO as a mainstream clinical discipline, so is very important to IO as a whole”.

Rahil Kassamali 2020 vision

Page 23

Matthew Johnston

Profile

Page 18

“Huge disparity” between embolization and uterine surgery numbers worldwide On average in France, 2,000 uterine artery embolizations (UAEs) are performed each year. In contrast, 40,000 patients have hysterectomies annually. This has led French interventional radiologists to protest the high number of “unnecessary” surgeries, and spurred the development of a nation-wide public awareness campaign (see page 6 for full story).

However, this is not just a French issue.

Afshin Gangi discusses IASIOS at the Asia Pacific Congress of Interventional Oncology (APCIO; 2–5 October, Kuala Lumpur, Malaysia)

I

ASIOS is built on the standards outlined in the Standards of quality assurance in interventional oncology document, published in 2018 by CIRSE’s oncology alliance subcommittee, which is chaired by Adam. The idea of a global quality assurance scheme for IO goes back even further, to 2012, when radiation oncologist Lizbeth ‘Liz’ Kenny (Royal Brisbane and Women’s Hospital, Brisbane, Australia) delivered a talk at CIRSE’s annual congress on the interventional oncologist’s place in a multidisciplinary cancer care team.

Kenny emphasised the importance of recognising interventional oncologists as “clinicians, not just technicians”. She recalls: “I thought I was being very provocative, but CIRSE was very supportive. Since then [2012], I have been involved with the oncology alliance subcommittee, and have pushed the importance of standards of practice. In the world of radiation oncology, the stakes are very high, so quality assurance is built into every single step of all we do. I could see that with IO, we either needed to bring it into the mainstream, or it would disappear. IASIOS brings IO into the mainstream—by having a really serious quality assurance and standards programme underpinning the discipline, IO is in a great place to offer high benefit care to patients, and to fully integrate interventional oncologists into the multidisciplinary cancer care team.”

Establishing quality assurance standards in interventional oncology

In 2015, the CIRSE oncology alliance subcommittee— Adam, Kenny, Afshin Gangi (University Hospital Strasbourg, Strasbourg, France), Thierry de Baère (Institut Gustave Roussy, Villejuif, France), José Ignacio Bilbao (Clinica Universidad de Navarra, Pamplona, Spain), Thomas Helmberger (Klinikum Bogenhausen, Munich, Germany), Riccardo Lencioni (Pisa University School of Medicine, Pisa, Italy), and Philippe Pereira (Minimally Invasive Therapies and Nuclear Medicine Heilbronn, Heilbronn, Germany)— worked with interventional oncologist Shahzad Ilyas and former chief medical physicist Keith Ison (both Guy’s and St Thomas’ Hospital, London, UK) to adapt the Standards for Radiation Oncology developed and published by the Royal Australian and New Zealand College of Radiologists (RANZCR), the Australian Institute of Radiography, and the Australasian College of Physicists, Scientists and Engineers in Medicine.

The group had to make these standards fit for purpose in the IO environment.

“This was a monumental effort,” Kenny describes.

The standards went through 30 iterations over three years prior to publication. “The real complexity was to make the standards simple, understandable, and truly Continued on page 2

JAMES SPIES (Georgetown University Hospital, Washington, DC, USA) reports that, “despite some progress in reducing the number of hysterectomies for benign conditions such as fibroids, with about a 10% reduction in the past decade, there are still eight to 10 times the number of hysterectomies as UAEs for fibroids in the USA.” A 2017 report by the Society of Interventional Radiology (SIR), The Fibroid Fix: What women need to know, provided insights into the lack of awareness. SIR commissioned a Harris Poll in June 2017 that surveyed 1,176 US women ages 18 and over. The poll found 62% of respondents had never heard of UAE and that 20% believed hysterectomy was the only treatment option for fibroids. Even those who were diagnosed with fibroids reported a lack of awareness, with 44% saying they had not heard of UAE. Of those who had, 75% said they did not learn about it from a gynaecologist.

“Our numbers for UAE are ridiculous,” José Urbano (Ramon y Cajal University Hospital, Madrid, Spain) says of Spain. According to the Spanish Society of Vascular and Interventional Radiology (SERVEI), 120–150 UAEs are performed each year in the country, which has a population of 44 million.

These experiences are echoed in Central America.

Speaking at SIR’s annual meeting in 2019 (23–28 March, Austin, USA), the only interventional radiologist in El Salvador, Ethel Rivas Zuleta (Universidad Dr José Matías Delgado, San Salvador, El Salvador), told delegates: “We face the same Continued on page 4

2

Oncology accreditation

March 2020 | Issue 77

International accreditation scheme “brings IO into the mainstream” Continued from page 1

relevant to patients and care providers. This is not a tick box exercise. The standards describe what great care looks like, which then facilitates discussion between interventional oncologists and hospital management over necessary infrastructure, equipment, and patient pathways.”

Following the structure of the Australian and New Zealand Standards for Radiation Oncology, CIRSE’s Standards of Quality Assurance in Interventional Oncology document is split into three sections. These are: staff and facilities, treatment planning and delivery, and safety and quality. The IASIOS accreditation system is based on these standards. Between the three sections, there is a total of 52 criteria, 27 of which are “core”. After paying the enrolment fee, an institution can achieve accreditation if it meets all 27 core criteria.

The IASIOS process is interactive: once an IO facility has applied for accreditation, a dialogue begins between it and the IASIOS team in the CIRSE office, which offers advice and guidance on how to improve the service, and is independent from the oncology alliance subcommittee. This conversation continues until accreditation is achieved. In exceptional cases, an institution may be awarded a “centre of excellence” accreditation if it fulfils the remaining 25 criteria.

Guy’s and St Thomas’ NHS Foundation Trust, London, UK, is the first in the world to be accredited through IASIOS. The centre gained accredited status in September 2019.

IASIOS is currently in a pilot phase, with eight centres across Europe, Asia, and Australasia enrolled in the programme to date. Two US centres are poised for potential future participation. CIRSE is working in collaboration with the Society of Interventional Oncology (SIO) to create a version of the IO standards appropriate to the pattern of practice in the USA. While in this pilot phase of the programme, the IASIOS committee at CIRSE, chaired by Jean Palussière (l’Institut de cancérologie Bergonié, Bordeaux, France), is listening to feedback on the scheme from the enrolled institutions, and making any necessary modifications.

Maria Weren, head of the department for certification and accreditation at CIRSE, expands: “I do not expect there to be too many changes at this stage. What I do foresee is some fine-tuning of our assessment process, and possibly to our application forms—so largely modifications to technical details. Any obstacles centres are repeatedly running into our expert group will of course also review.” The official, global launch of IASIOS is planned for early 2021.

Building a global IO network

News in brief

Kenny is enthusiastic about the potential of the IASIOS scheme to build an international network of interventional oncologists.

She tells this newspaper: “In due course, we anticipate building a network of centres that have achieved accreditation. I see this as ultimately an interconnected system of institutions offering support, encouragement, and advice for the betterment of all. IASIOS will uplift the whole of IO.” There is no precedent for this type of international interconnectivity, Kenny explains: “There is no other movement that does what IASIOS does. The standards define the infrastructure, staffing, and safety requirements to bring IO into mainstream cancer care. If IO is to survive and flourish, it cannot just be a technical specialty under the direction of surgeons or medical and radiation oncologists. Interventional oncologists need to be considered a genuine partner in cancer care, and that is what IASIOS does.”

In Weren’s eyes, too, the IASIOS programme will bring increased recognition to the discipline, through giving interventional oncologists greater control of the entire patient pathway and a louder voice at interdisciplinary meetings. “IASIOS benefits not just patients, but also interventional oncologists,” she opines.

“It is an initiative by interventional oncologists, for interventional oncologists, because the standards look at the whole patient pathway. The standards

The latest stories from the interventional world

n INTERDISCIPLINARY JAY MATTHEWS: CLTI The real CARE procedure, the The robotic 32nd technologists International Symposium loaded the devices on into Endovascular the robotic armTherapy as soon (ISET; as access 22–25 was January, completed Hollywood, by the bedside USA) physicians. had a particular “Once thefocus guiding oncatheter treating critical was placed, limb-threatening the robotic ischaemia arm took over.

(CLTI).

Everything In the session that we would “Improving usually outcomes do with and our hands, prognosis we for did CLI”, with the conference robotic arm attendees during the learnt intracranial about thepart global of scale the procedure,” of the disease, Pereira theexplains. importance “I was of adequate controlling wound the armcare withpost-treatment, the console, using andthe thejoysticks possibility while of revascularisation looking at the screens in theinoutpatient front of me. environment.

The roboticThe arm session navigated was all co-developed the devices.” and sponsored by the CLI Global Society, a patient advocacy organisation that aims For more to improve on thispatients’ story goquality to page of 16 life by preventing amputations and death due to the condition. n AFTER REMOVING THE COIL: For The more cassette on this [of the story robotic go toarm] page had 8 to be changed.

We changed the sterile part of the robotic arm and n weRADIOEMBOLIZATION continued the procedureACHIEVES with a new cassette SIGNIFICANT until the aneurysm TUMOUR was completely REDUCTION occluded, but our The teams firstwere prospective trained tostudy do this.” on the combination of 177 peptide Pereira receptor acknowledges radionuclide that procedural therapy with time LuDOTATATE “probably increased and 166Hoslightly”, radioembolization, as it represented published a new in Lancet workflow Oncology, for the team. has shown While he that does significant not believe tumour that reduction the roboticcan procedure be achieved itself in has patients a largewith learning bulkycurve, liver he says: disease, “There a significant is a big learning advancement curve asconsidering a team.” He the speculates liver is the thatmost in the commonly future, theaffected physician organ performi.” in metastatic disease and is the most incriminating factor For more for patient on this survival. story go to page 28.

IASIOS brings interventional oncology into the mainstream—by having a really serious quality assurance and standards programme underpinning the discipline.”

For n STEM more GROWTH on this story : go to page 15

The cassette [of the robotic arm] had to be changed. n WeCOALITION changed theOF sterile CTACE part of the robotic arm and AND we continued IMMUNOTHERAPY the procedure with a new cassette Preliminary until the aneurysm evidence was suggests completely that occluded, combiningbut our conventional teams were trained transarterial to do chemoembolization this.” (cTACE) Pereirawith acknowledges immunotherapy that could procedural be beneficial time to patients “probablywith increased unresectable slightly”, liver ascancer, it represented writes Rafael a new Duran. workflow Hebut highlights our teams the were role oftrained Vectorio to do (Guerbet) this butin standardising our teams were thetrained cTACEtotechnique, do this.” which he says “is needed for better reproducibility”, and explains how For more immunotherapy on this story could be given systematically, through go to page locoregional 36. delivery within the Lipiodolbased emulsion, or injected intratumourally.

will introduce systemic preprocedural assessment and patient follow-up by interventional oncologists, which I anticipate will provide greater visibility to IO. Interventional oncologists are ready to assume the role and responsibilities of a specialty, but they need to have a voice and they need to have a fixed place in the multidisciplinary cancer care team. This will enrich the discussion and widen the perspective for the patient.”

For more on this story go to page 25

www.interventionalnews.com Editors-in-chief:

Design:

Publisher:

Advertising:

Professor Andy Adam, Dr Brian Stainken Stephen Greenhalgh

Content director: Urmila Kerslake

Editor:

Suzie Marshall suzie@bibamedical.com

Editorial contribution:

Dawn Powell, Jocelyn Hudson, Liam Donovan

David Reekie and Terry Hawes Shilpa Suthar shilpa@bibamedical.com

Subscriptions:

Susan Couch susan@bibamedical.com

News or advertising queries: Tel: +44 (0)20 7736 8788

Published by:

BIBA Publishing, which is a subsidiary of BIBA Medical Ltd BIBA Medical, Europe, 526 Fulham Road, Fulham, London, SW6 5NR, United Kingdom Tel: +44 (0) 20 7736 8788 BIBA Medical, North America, 190 S. LaSalle St. — Suite 2100, Chicago, IL 60603, United States Tel: +1 708-770-7323

Reprint requests and all correspondence regarding the newspaper should be addressed to the editor at the above address. © BIBA Medical Ltd, 2020 All rights reserved.

Write to us!

If you have comments on this issue or suggestions for upcoming editions, write to suzie@bibamedical.com

Next issue: June 2020

Printed by:

Buxton Press

facebook.com/interventionalnews linkedin.com/company/interventional-news/

@in_publishing

4

Uterine interventions

March 2020 | Issue 77

“Huge disparity” between embolization and uterine surgery numbers worldwide France: 2,000 UAEs/yr 40,000 uterine surgeries/yr

Continued from page 1

Australia: 145 UAEs/yr 30,332 uterine surgeries/yr

El Salvador: (1 institute) 6 UAEs/yr 746 uterine surgeries/yr Spain:

125–150 UAEs/yr 50,000 uterine surgeries/yr

problems in our region”. Fibroids are the leading indication for hysterectomy in El Salvador. In 2018, 746 hysterectomies were performed in Zuleta’s institution, mostly in women between 30 and 50 years of age. Six women were treated with UAE. Zuleta noted that none of these six patients were referred by an obstetrician or gynaecologist: four were either doctors themselves, or related to one, and two had found out about UAE themselves online.

On the other side of the world, Gerard Goh (The Alfred Hospital, Melbourne, Australia) and colleagues recently analysed Australian Medicare data, and found a “huge disparity” between the number of hysterectomies performed each year compared with the number of UAEs. The data showed that, on average over the last five years, 30,332 uterine surgeries are performed each year. According to Goh, you would expect four to five thousand of these (approximately 30%) to be treatment for fibroids. Fewer than 145 UAEs were performed on average per year. “Based on the suggestion that 20% of hysterectomies in Australia are for fibroid-related disease, this estimates 6,066 fibroid-related surgeries per year,” Goh comments.

He adds that he thinks it is “interesting” that a procedure which has been proven to be efficacious has such a poor take-up globally. A major reason for this, he posits, is the lack of “patient and referrer awareness”. To tackle this issue, he believes interventional radiologists from across the world need to “come together” and work with societies to help educate patients and referrers, because currently “a lot of women are really missing out on uterus-sparing surgery for fibroids”.

Why this discrepancy?

Speaking specifically of the US population, Spies expands on his thoughts for the causes of the discrepancy between hysterectomy patient numbers and UAE patient numbers: “I believe that there are a range of factors, which could include economic considerations, but also persisting scepticism among gynaecologists about UAE. Despite considerable evidence of excellent outcomes after UAE, UAE patients are

more likely to need additional interventions than those that have hysterectomy and many gynaecologists seem convinced that a definitive treatment like hysterectomy is best. [However, we must take into account] women’s desire to avoid hysterectomy.

“In the USA, we have made efforts for years to raise the profile of UAE, with some success. Still, it is an effort of decades that will cause change. Currently, SIR is engaged in a multidisciplinary creation of practice guidelines for the procedure.”

These guidelines, which are expected to be published in early 2021, are being developed by physicians from the specialties of gynaecology, body imaging, and IR. “The guidelines will amplify SIR’s past awareness and education efforts by providing physicians and patients with evidence-based recommendations for the optimum care of patients with symptomatic fibroids,” SIR president Laura Findeiss (Grady Memorial Hospital, Emory University School of Medicine, Atlanta, USA) comments.

In addition to SIR, the participating societies are Cardiovascular and Interventional Radiological Society of Europe (CIRSE), Fédération Internationale de Gynécologie et d’Obstétrique (FIGO), the American Association of Gynaecologic Laparoscopists (AAGL), the American Society for Reproductive Medicine (ASRM), and the Society for Advanced Body Imaging (SABI).

To attract a Medicare rebate for UAE in Australia, the patient must be referred by an obstetrician/gynaecologist, which Goh says “brings up potential referral bias”. However, he notes that the low UAE rate in Australia is “likely multifactorial”, and that IR can only fulfil its potential in terms of treating the appropriate number of eligible patients when interventional radiologists “take greater clinical ownership of their patients”. To Goh, this looks like preprocedural consultations with patients, postprocedural care, and having an inpatient bed card. He also stresses that gynaecologists and interventional radiologists alike should have an understanding of the pros and cons of

both embolization and surgical options, to allow patients to make an informed decision about their fibroid treatment.

Urbano concurs with Goh’s assessment that there are numerous reasons for the underutilisation of UAE globally, and particularly in Spain. “Of course, like in France, gynaecologists actively block this treatment because they fear losing patients,” he says. “Furthermore, when obtaining informed consent for hysterectomy, it is mandatory to notify the patient that UAE is offered as an alternative, but it is often not even mentioned. Gynaecology tends to be a speciality that does not participate in multidisciplinary work. They have countless patients, they do their own diagnostic tests, and their patient management is routine.

“Interventional radiologists have too much work in Spanish public hospitals, so UAE is not an important focus for them.

In addition, while they are experts at doing the procedure, they are not always involved in the diagnosis, pain management, and patient follow-up. Interventional radiologists are only fully involved in the UAE process in private practice and some public hospitals. Less than 50% of IR services in Spain have a clinic and beds. In my experience, this is crucial for us to do all those type of procedures in which IR competes with other specialties.”

Zuleta argues the same in El Salvador.

She says the underutilisation of UAE is due to “a lack of knowledge by other specialties, the usage of old protocols and guidelines, and highly unequal access to healthcare for women. We do have access to technology: we have angiosuites, CTs, ultrasounds, MRI, but what we lack is education. We at SIDI [Sociedad Iberoamericana De Intervencionismo] believe that supporting education in our countries is the best way to improve the management of patients, especially in IR.”

Public awareness initiatives

In the USA, SIR is running its own campaign—the Vision to Heal, Together, launched in September 2019—to bring IR procedures to the forefront of the public consciousness. According to an SIR press release last year, this aims to “build

stronger partnerships with referring physicians and to empower patients to ask about IR as a treatment option”.

The campaign is not specific to UAE; it is focused more broadly on vascular disease, cancer, and men’s and women’s health conditions, which includes uterine fibroids. SIR is using a combination of radio, digital, and social media advertising in four pilot US markets (Washington, DC; Rochester; Little Rock; Portland) to spread its messaging.

The campaign was inspired in part

by SIR’s 2017 report finding the lack of awareness among patients and the lack of information from referring physicians.

“By educating both groups, we hope to not just reduce the knowledge gap, but to build trust among the specialities so that patients are presented with all of their treatment options up front,” says Findeiss.

The Vision to Heal, Together campaign ran through to the end of March 2020. SIR reports positive engagement from patients on advertisements and social media posts.

“We have seen friends sharing information with friends in need and others simply commenting to vouch for the life-saving and quality-of-life improving power of interventional radiology,” Findeiss comments. “There is a real desire and need for more information about minimally invasive treatments across the board.”

In Australia, the wording of the Medicare item for UAE is under review, which Goh hopes will change to improve patient access to the procedure. The Interventional Radiology Society of Australasia (IRSA), of which Goh is president, is “working on the UAE issue.”

Goh says: “We are working with some other stakeholders to increase public awareness online, and via print and social media.” IRSA is updating its website to list practioners who can perform UAE, and is leading a global position statement to help further increase awareness.

In Spain, Urbano stresses that the key lesson from the French action is that it is patient-focused. “SERVEI’s position is not to start turf battles,” he says. “We have lost too much time and energy in the past with no-way fights. Our policy is to show what IR work is, and to demonstrate the advantages of our treatments to patients.”

6

Embolization in France

March 2020 | Issue 77

Paris protests

Interventional radiologists protest “unethical” number of hysterectomies French interventional radiologists are protesting the high number of “unnecessary” surgeries taking place nationwide, stressing that there are minimally invasive alternatives with fewer complications available. The Federation de Radiologie Interventionnelle (FRI), has launched a public awareness campaign to educate potential patients about interventional radiology (IR) procedures, with a specific emphasis on uterine artery embolization (UAE), which it claims is an underused, safe, and effective option for patients who do not want a hysterectomy.

“I

think gynaecologists have a real scepticism of the effectiveness of UAE,” FRI president Hélène Vernhet-Kovacsik (Arnaud de Villeneuve Hospital and Montpellier University, Montpellier, France) tells Interventional News. “They do not trust this technique, which they do not practice.”

The French guidelines for the therapeutic management of uterine fibroid tumours, published in the European Journal of Obstetrics and Gynecology and Reproductive Biology and last updated in 2012, state that “Because UAE is an effective treatment with low long-term morbidity, it is an option for symptomatic fibroids in women who do not want to become pregnant, and a validated alternative to myomectomy and hysterectomy that must be offered to patients.” However, Vernhet-Kovacsik says that though UAE is in the guidelines, and “should be offered as an alternative to hysterectomy for all patients”, it is not.

On average 2,000 UAEs are performed a year in France. In contrast, 40,000 patients have hysterectomies annually.

morbid than hysterectomy, cited in the gynaecology guidelines [and] with long established scientific evidence, remains as little used?”

The communications working group organised a press conference with French media on 23 January at the Georges Pompidou European Hospital in Paris. This resulted in a double page spread appearing in the non-specialist daily newspaper Le Parisien, featuring patient testimonials in favour of UAE, and interviews with Vernhet-Kovacsik, Sapoval, and other French interventional radiologists with private practices explaining technical details of the procedure, as well as describing how and why it is underutilised. The article cited a lack of information provided to the patient

alternative surgical techniques. This also made it possible for us to directly address patients by proposing solutions to symptoms that are not always recognised as pathological, but [are] handicapping in everyday life, such as pelvic pain or urinary discomfort.”

FRI has taken a multimodal approach to disseminating its message. The society made a short animated film about pelvic IR, which is freely available on its YouTube channel. This also hosts video coverage of radiology congresses and the preprocedural film shown to patients in waiting rooms. Additionally, Sapoval is working on a patient-facing website, to launch 13 June this year. “We are testing and finalising it now,” Sapoval tells Interventional News, “then we will be launching it nationwide. The website will inform patients of treatments for fibroids other than hysterectomy, so they can be aware that they may not need one.” FRI also plans to use Facebook to engage the online community through question and answer sessions, mediated by specialised health publications, designed to offer patients a chance to speak directly with an interventional radiologist.

This direct engagement is part of a trend Vernhet-Kovacsik has identified.

“The patient-doctor relationship is changing—it is no longer directive, but participative. The dissemination of information on the web via social media and the creation of user groups should be [a step] in the right direction.” Following the increased interest in UAE that succeeded the Le Parisien article, FRI set

“Some resistance” to UAE from referrers

When questioned about why he thinks the discrepancy between hysterectomy and UAE numbers exists, Sapoval is categorical: “There is some resistance.

Some [obstetricians/gynaecologists] do not know about UAE, and some do know, but do not want to refer patients because they are paid to perform hysterectomies.”

Vernhet-Kovacsik proposes another reason for the low referral rate: “In my opinion, this goes beyond simple corporatist considerations. Women have a doctor who has looked after them for years, has helped them give birth to their children, knows their intimate problems.

A recognition has been created and it is difficult for patients to dare to express desire for a treatment different to the one proposed by the gynaecologist!

However, it is shocking to offer a firstline technique (hysterectomy) which has twice as many serious complications as embolization, sometimes requires transfusions, and always prolongs work stoppage. Gynaecologists’ main argument is the increased risk of embolization versus myomectomy regarding fertility, but the vast majority of patients are over 43 years old, are not keen on pregnancy, and are treated by hysterectomy and not myomectomy: so why not perform an embolization? I think our target must be this population precisely!”

UAE preserves sexual function and bodily integrity

Raising awareness

When first elected president of the FRI, Vernhet-Kovacsik set up specific working groups within the society. The communications working group, headed

by Vincent Vidal (Hôpital de la Timone, Marseille, France), have launched a public awareness campaign in an effort to educate the public about UAE and other minimally-invasive options.

With a focus on pelvic interventional radiology (IR) in 2020, the society’s edifying efforts are dedicated to UAE, haemorrhoids, and prostate artery embolization (PAE). As a worldleading advocate of the “emborrhoid” technique—the embolization of the superior rectal arteries—and the lead author of the 2015 study demonstrating the procedure’s efficacy, Vidal is a global specialist on haemorrhoids. PAE is the principle purview of Marc Sapoval (Georges Pompidou European Hospital, Paris, France, and founder of the GEST Symposium), who is a prominent member of FRI. UAE was chosen for more political reasons: in Vernhet-Kovacsik’s words, the lack of referrals and general awareness “seemed to us very stigmatising and unfair. How is it that a technique recognised as effective and less

radiologists. This is one of the interventions where we have strong, level one evidence, and despite a lot of effort, we have not seen a lot of movement in the last few years. This is the case in many other countries as well, so we wanted to take the lead and raise the flag for UAE.”

Helene Vernhet-Kovacsik

Marc Sapoval

from interventional radiologists’ medical colleagues leading to a low referral rate.

Following this, Vernhet-Kovacsik recounts how Sapoval appeared on French radio to discuss embolization. “[He] brilliantly exposed the clinical and economic effectiveness of all the IR treatments, and presented emerging techniques,” she enthuses. Following the success of these media engagements, FRI produced a press kit summarising current scientific data on pelvic IR, which can be used to inform future media opportunities, in France or abroad.

“We also wanted to communicate [the impact on] quality of life,” VernhetKovacsik says of the FRI media strategy, “because it has become a major concern for patients, and is an advantage of IR procedures, which have very low morbidity and require very short hospitalisations in comparison with

We should [...] encourage women to dare to ask for fair treatment.” up an online directory of pelvic IR centres in France, allowing patients to find these services more easily.

Sapoval believes this increasingly participative relationship is important because patients will have to lead the charge in advocating for UAE. “We have a very unethical situation in France where women get hysterectomies instead of embolizations because the obstetricians/ gynaecologists are operating on patients instead of referring them to interventional

The EFUZEN study, conducted in 2017 by Vernhet-Kovacsik, Sapoval, and others from the French Society of Interventional and Cardiovascular Imaging (SFICV) research group, evaluated sexual function before and one year after UAE. The authors concluded that at one-year post-embolization, UAE significantly improves all aspects of sexual function and quality of life.

Vernhet-Kovacsik stresses the pertinence of this finding: patient’s quality of life and sexual function “are rarely addressed by gynaecologists”, she says, adding that “there is a close link between fibroids and their treatment, and these aspects of life.

“The uterus is not only used for reproduction; preserving bodily integrity is also a current demand,” she comments.

“I think we should all take advantage of the ‘me too’ phenomenon and, as interventional radiologists, speak out and encourage women to dare to ask for fair treatment when it comes to preserving their femininity and their quality of life. We could certainly work together: interventional radiologists, gynaecologists, and patients. I am less concerned about the future of PAE, however technically more difficult, because the importance of preserving sexual function in men will never be questioned!”

8

Wound care

March 2020 | Issue 77

Interdisciplinary wound care teams are integral for CLTI patients’ care, ISET session concludes The 32nd International Symposium on Endovascular Therapy (ISET; 22–25 January, Hollywood, USA) had a particular focus on treating critical limb-threatening ischaemia (CLTI). In the session “Improving outcomes and prognosis for CLI”, conference attendees learnt about the global scale of the disease, the importance of adequate wound care post-treatment, and the possibility of revascularisation in the outpatient environment. The session was co-developed and sponsored by the CLI Global Society, a patient advocacy organisation that aims to improve patients’ quality of life by preventing amputations and death due to the condition.

Barry Katzen speaking at ISET 2020

M

ichael Jaff (Harvard Medical School, Newton, USA), vice president and founding board member of the CLI Global Society, spoke first to define CLTI and to outline the risks it poses to patients. “This is obviously a very important session for all of us who deal with these patients for a whole host of reasons,” he said. “We need to recognise that these patients are begging for our help.”

He pointed out that patients with the most advanced class of the disease, categorised as Rutherford class 6, “had the highest prevalence of bilateral limb amputations before coming for this intervention”. He called this the “striking, sobering reality” of CLTI in the USA. “The prognosis for one year after the diagnosis of CLTI is terrible: 25% of patients will have died, and 30% are still alive but have had a major amputation,” he disclosed. “Patients with chronic CLTI have a three-year limb-loss rate of approximately 40%, and quality of life indices of CLTI patients are very similar to end-stage cancer. Readmission rates are very high. We must identify these patients early, and we must have a sense of urgency for revascularisation. Amputation has to be considered the last possible option, not the first.”

Iterating this message, ISET founder and president of the CLI Global Society Barry Katzen (Miami Heart and Vascular Institute, Miami, USA) said: “Part of what we are trying to do is get this call to arms, and hearing Michael [Jaff]’s sentinel announcement about how vigilant all of us have to be to implement change is an important part of the message we would like to deliver.”

As the only society in the world dedicated to serving this patient population, the CLI Global Society is using its resources to get more data on the disease.

Katzen explained to the ISET audience: “One thing you might know from your own hospitals is there are insignificant DRG [diagnosis-related group] codes, it is hard to actually quantify the cost impact, and the federal government and payers do not really understand or recognise CLTI as an entity or a disease, which leads

to a lack of financial resources, payment for physicians, payment for hospitals. So one of the things that the CLI Global Society did is invest its resources in creating science.”

Citing a recent CLI Global Society study published in the Journal of the American Heart Association (JAHA) that used Medicare data to investigate the impact of

Patients with chronic CLTI have a threeyear limb-loss rate of approximately 40%, and quality of life is very similar to end-stage cancer.”

CLTI on the US population, Katzen said that patients with this disease have a poor long-term prognosis following their initial diagnosis, specifically pointing out that through four years, only 42% were alive and free from major amputation. “We need to raise disease awareness,” he said, echoing Jaff, “and we need to implement coding to better define CLTI, so that when you are looking after these patients, CMS can actually identify them. This is a major initiative of the CLI Global Society.”

The CLI Global Society, as “a non-professional society without political turf”, in Katzen’s words, has forged a coalition between the Society for Vascular Surgery (SVS), the Society for Cardiovascular Angiography and Interventions (SCAI), the Society of Interventional Radiology (SIR), and the Society for Vascular Medicine aimed at initiating a coding change regarding CLTI. Katzen anticipates this being implemented in October 2020.

Richard Neville (Inova Heart and Vascular Institute, Falls Church, USA) took to the podium next to discuss

the importance of an integrated approach to the CLTI patient. “It is frustrating,” he said, “because I feel as though I have been giving this presentation for about twenty years. I was talking with Vickie [Driver, Brown University School of Medicine, Providence, USA, fellow panellist] earlier, and we were saying how this idea of a multidisciplinary team started with the diabetic foot. It seems that they have had a lot more progression and moved things along faster than we have with these CLTI teams. But we have to keep pushing forward—I think as more people get interested and recognise this is an important disease entity.”

Promoting the idea of an integrated limb preservation team, Neville said the ultimate goal is to decrease the rate of amputation. The team would also work together to decrease the rate of patient mortality and medical comorbidity, address the current disparity of care, and raise awareness of endovascular methods of limb preservation. A multidisciplinary approach to CLTI treatment would streamline care, he argued, and would provide a referral source for the community, as well as a forum for research and both patient and physician education.

“There has been good data across the world showing that these teams can reduce amputation rates,” Neville disclosed, highlighting data from the USA (82% reduction), Sweden (78% reduction), and the UK (62% reduction).

Generalising rules for establishing a multidisciplinary team is challenging, he continued, as the development of an integrated CLTI group depends on the people and facilities available locally. However, Neville emphasised that one commonality was the need for a physician champion: “You need somebody in the system that just takes this to heart. I would argue that you need someone that wants to take care of the vascular needs of the patient, someone that wants to work on their soft tissue, and we are now going to add vascular medicine in the mix. But you need someone who is passionate who wants to put a team together, go to conferences, and talk to people.”

Describing giving a similar talk in Beijing, China, Neville shared some advice from his Asian colleagues: “We used to call this the limb salvage centre [where the interdisciplinary CLTI team were based], but the gentleman who was hosting me in Beijing told me we cannot call it that—in Mandarin, the same Chinese character for ‘salvage’ is the same as for ‘trash’. So it is now the limb preservation programme!”

Commenting on the limb salvage versus limb preservation debate, Driver began her talk with an anecdote from her military days: “A general came to see me one day, he had been in Afghanistan and Iraq overseeing 35,000 of our [US] troops. He was diagnosed with diabetes. How was he diagnosed with a foot sore that would not heal and an infection? He went on to lose part of his foot. He said to me, ‘Thank god you do not call it limb salvage anymore’.”

She continued: “Wound care is never basic in a CLTI patient. In fact, it requires advanced care before and after vascular interventions.”

10

Paclitaxel coverage

March 2020 | Issue 77

The clash of the paclitaxel metaanalyses: Katsanos et al suggest higher risk of death or amputation at one year, while Dinh et al find “no observed difference” in mortality in CLTI patients A new meta-analysis, published in the Journal of Vascular and Interventional Radiology (JVIR), suggests significantly worse amputation-free survival at one year with the use of paclitaxel-coated balloons in arteries below the knee for chronic limb-threatening ischaemia (CLTI) patients, but some experts advise cautious interpretation of results and question whether these data will impact practice. The new systematic review and study-level metaanalysis of eight randomised controlled trials was conducted by Konstantinos Katsanos (University of Patras, Patras, Greece) and colleagues.

S

everal physician thought-leaders believe that the conclusions are not yet definitive, with multiple peripheral vascular interventionalists cautioning how these data should be interpreted. Most emphasised the challenge of teasing out scientifically meaningful information from a patient cohort that suffered from CLTI, which is associated with “mortality, amputation, and impaired quality of life”. They also point to the inclusion of unpublished data (which has therefore not gone through the peer-review process); the inclusion of summary-level data; the inclusion of the IN.PACT DEEP data (which used a device that has long since been withdrawn from the market); and the study’s shortterm follow-up period.

February 2020 brought another paclitaxel device meta-analysis of randomised controlled trials in chronic limb-threatening ischaemia (CLTI) patients. Krystal Dinh (Westmead Hospital, Sydney, Australia) et al report online ahead of print that the risk of allcause mortality after treatment with paclitaxel-coated devices versus uncoated controls in patients with CLTI in the Journal of Endovascular Therapy (JEVT) very differently than did Katsanos and colleagues earlier this year. In fact, Dinh et al, due to the clear benefit and no suggestion of a link between the use of paclitaxel-coated devices and mortality, “recommend their continued use in this high-risk patient population”.

The Katsanos et al meta-analysis

As reported in JVIR, the eight randomised controlled trials included in this most recent summary-level analysis included 1,420 patients, of which 1,380 (97.1%) had CLTI. The primary safety and efficacy endpoint was amputation-free survival, defined as freedom from allcause death and major amputation (above the ankle). At one year, there was a 13.7% crude risk of death or limb loss among the 835 patients who had received treatment with paclitaxel-coated balloon—74 deaths and 40 major amputations. In comparison, the crude risk of death or limb loss in the cohort treated with an uncoated balloon was 9.4%—39 deaths and 17 major amputations. For the primary amputation-free survival endpoint, the number needed to harm was estimated to be 22 patients (95% confidence interval [CI] 11–94). The authors claim there was consistent evidence from the randomised studies that freedom from major amputation or death was significantly lower in cases with paclitaxel-coated balloons with a pooled hazard ratio (HR) of 1.52 (95% CI 1.12–2.07; p=0.008).

However, Katsanos et al also report consistent evidence that paclitaxel reduces the need for target lesion revascularisation in below-the-knee arteries by approximately 40%. Target lesion revascularisation constituted the secondary efficacy endpoint. The crude risk of target lesion revascularisation was 11.8% (103 revascularisation events among 875 cases) versus 25.6% (159 events among 620 control patients) for patients treated with a paclitaxel-coated balloon and an uncoated balloon, respectively. The calculated pooled risk ratio was 0.53 (95% CI 0.35–0.81; p=0.004), with a

corresponding number needed to treat of eight patients (95% CI 4–25).

The study authors claim there is a dose–response relationship between paclitaxel and amputation-free survival. They compared outcomes with low and high doses of paclitaxel, and found significantly more deaths or amputations (lower amputation-free survival) in cases with high-dose devices, defined as 3–3.5µg/mm2 (HR 1.62; 95% CI 1.16–2.27; p=0.005). In comparison, amputation-free survival was higher (fewer deaths or

Amputationfree survival was significantly worse in case of paclitaxel.”

This meta-analysis has demonstrated there there is no increased risk of all-cause mortality in a predominantly CLTI patient population treated with paclitaxel-coated devices versus uncoated devices.” fewer major amputations) when a low-dose device (2µg/mm2) was used (HR 1.06; 95% CI 0.48–2.34).

This low dose was found to be safe and effective, the authors report.

The authors of the present study say they performed a “comprehensive literature review” due to the “major concerns about systemic safety of paclitaxel” prolific in the endovascular community today as a result of their earlier meta-analysis published in the Journal of the American Heart Association (JAHA) in 2018. This concluded that there was an increased association of mortality beyond two years through five years of followup when paclitaxel-coated balloons and paclitaxeleluting stents were used in the femoropopliteal arteries.

The Dinh et al meta-analysis

Dinh and colleagues, including Ramon Varcoe (Prince of Wales Hospital, Sydney, Australia), Andrew Holden (Auckland Hospital, Auckland, New Zealand), and Peter Schneider (University of California San Francisco, San Francisco, USA) performed a systematic review on 5 November 2019 to identify randomised controlled trials using intention-to-treat analysis to compare a paclitaxelcoated device to an uncoated device in peripheral arterial disease patients having clinical follow-up of at least

six months. Half of the study population had to have CLTI, or extractable data on the CLTI subgroup, if this constituted less than 50%, write the authors.

The search revealed 11 trials with 1,450 patients who were randomised to treatment with a paclitaxelcoated device (n=866) or an uncoated control (n=584).

The group included 94.3% (1,367) patients with CLTI. The single endpoint was all-cause mortality, which was analysed by pooling the mortality data in a random effects model. Summary statistics are expressed as relative risk ratios (RR) with a 95% confidence interval (CI).

Importantly, Varcoe clarified that this meta-analysis included the five-year IN.PACT DEEP results that were overlooked by Katsanos and colleagues. Further, they included only studies that were published, or those that authors were able to confirm had been accepted for publication and were in press.

As described in JEVT, the mean follow-up was 25.6 months (range 6–60) and 10 of 11 studies reported a minimum 12-month follow-up. There were 18.6% (161) deaths in the 866 patients in the paclitaxel device group and 19.9% (116) deaths in 584 patients who received treatment with a non-coated device (RR 0.93, 95% CI 0.78–1.12, p=0.45).

This led the investigators to conclude that “there was no observed difference in short- to mid-term mortality among a pooled patient population of predominately CLTI patients treated with paclitaxel-coated balloons or stents compared with uncoated controls”.

They write: “This meta-analysis has demonstrated that there is no increased risk of all-cause mortality in a predominately CLTI patient population treated with paclitaxel-coated versus uncoated devices. With clear benefit and no suggestion of a link between the use of paclitaxel-coated devices and mortality, we recommend their continued use in this high-risk patient population.”

Dinh and colleagues note that the present study was performed “in direct response” to the meta-analysis

by Katsanos and colleagues, published in JAHA in December 2018, that identified higher mortality rates in PAD patients with claudication who underwent endovascular treatment of the lower extremity with paclitaxel-coated balloons and stents.

“In contrast to those findings,” the authors note, “this study found no such association for patients undergoing treatment for CLTI, with similar overall death rates of 18.6% and 19.9% in the drug-coated and uncoated device control groups, respectively”. He continued: “We also observed no effect of paclitaxel dose, target vessel location, or length of the lesion on morality rates”.

Considering the wider debate surrounding drugcoated devices, Dinh et al note that there is a great deal of ongoing work to determine whether the safety signal observed in patients with claudication represents a drug toxicity effect or a statistical association.

However, they also remark that the benefits of paclitaxel-coated devices are “well established” and “withholding their use in CLTI patients is likely to detrimentally affect patient outcomes as patients are subjected to increased numbers of interventions and high-risk open surgical procedures, likely leading to increasing rates of amputation and mortality”.

They add: “This subset of PAD patients has the most to lose if paclitaxel-coated devices were to become unavailable, which suggest there is no increase in allcause mortality.”

The authors note a few limitations of the present study.

Firstly, they mention that the number of studies and participants was smaller than that of the 2018 Katsanos et al meta-analysis. Therefore, they suggest, this analysis may be “underpowered” and “susceptible to type II error,” particularly at the time points beyond one year.

Also, like the 2018 Katsanos et al meta-analysis that preceded it, this investigation was performed at a summary level that was unable to collect patient level data and specific causes of death. “Further insights are likely to come from a more detailed meta-analysis performed at an individual patient level,” they remark.

Regulation

Issue 77 | March 2020

11

THIS ADVERTORIAL IS SPONSORED BY TRISALUS LIFE SCIENCES

CMS Transitional Pass-Through Payment programme paves the way for cutting-edge treatments The Medicare Transitional Pass-Through Payment (TPT) programme is designed to foster innovation and increase access to cuttingedge treatments that benefit patients. The Centers for Medicare and Medicaid Services (CMS) believes the programme is important for hospitals to receive TPT payment for products that offer substantial clinical improvement. One goal of the programme is to target TPT payments for those devices where cost considerations might be most likely to interfere with Medicare patient access.

P

atient access is at the heart of the TPT programme. CMS understands that relentless innovation is a crucial driver in creating value across all industries. Seema Verna, CMS administrator, remarks: “Innovation is the fuel that powers the engine of progress and creativity. [...] We are committed to removing government barriers and modernising regulations around new technologies to ensure safe and effective treatments are readily accessible to beneficiaries without delaying patient care.”1 To facilitate beneficiary access to innovative medical devices, drugs, and biologicals, Congress established the TPT payment programme to prevent inadequate payment when used in an appropriate outpatient setting. CMS provides the TPT payment so as not to prevent use of new technologies due to cost concerns. The programme allows Medicare to collect data, and impacts CMS’ ability to establish appropriate permanent rates that are not described by existing categories. By addressing financial risk for outpatient facilities and mitigating the financial deterrent to innovative product utilisation, Medicare patients are more likely to gain access to new products through this programme.2 Historically, very few devices have qualified for TPT. In the last four years, only six device applications (out of 26) have been approved for the TPT programme. While TPT status has been in place for 20 years, only a very limited number of products have been approved because the programme requirements are so narrow. CMS reviews eligible device applications based on a demonstration of the following criteria: Recent US Food and Drug Administration (FDA) approval/clearance (generally within three years) Not appropriately described by another existing category or one previously established for TPT Substantial clinical improvement over currently available treatments

TriNav™ Infusion System—one of five device TPT approvals granted this year The TriNav Infusion System, which CMS approved TPT status for in November 2019, is the only TPT-approved device specifically designed for interventional radiology (IR) procedures. TriNav is designed to help overcome the infusion barriers that limit therapeutic uptake. In the Medicare hospital outpatient prospective payment system (OPPS) and ambulatory surgical center (ASC) payment system 2020 final rule, CMS stated that TriNav meets the criteria for device pass-through payment including newness, cost, and substantial clinical improvement.

For those devices granted TPT status effective 1 January 2020, pass-through payments will mostly

vasculature while protecting heathy tissue.3, 5, 7

New HCPCS code information

PEDD™ with SmartValve™

The TriNav Infusion System meets the criteria for device passthrough payment status including newness, cost, and substantial clinical improvement.”

Not intended as an endorsement by CMS.

likely remain available until 31 December 2022.

A novel drug-delivery mechanism

Fundamental to TriNav is the Pressure-Enabled Drug Delivery™ (PEDD™) approach with SmartValve™ technology. To overcome pressure barriers that limit flow, PEDD with SmartValve creates a high-pressure gradient that improves delivery and penetration of therapeutic agents.3–7 The porous expandable SmartValve is a first-of-kind proprietary technology shown to modulate pressure and flow for optimal therapy delivery and deeper penetration into the

Medicare’s transitional pass-through payment programme is designed to benefit patients who receive treatment with certain products in hospital outpatient departments (HOPDs) and ASCs. Medicare makes the additional TPT payment for devices where cost considerations might be most likely to interfere with patient access. It allows for CMS to collect necessary data and assign appropriate permanent codes and rates, paving the way for routine Medicare reimbursement later.

CMS assigned the TriNav Infusion System to the Health Care Common Procedure Coding System (HCPCS) code C1982 (catheter, pressure-generating, one-way valve, intermittently occlusive). When the device is used, CMS has stated it should always be billed with 37243 (vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; for tumours, organ ischaemia, or infarction).

While most payers usually follow suit with Medicare B coverage policy, the reimbursement methodologies and amounts may vary. Facilities are encouraged to contact payers prior to using a product on TPT status to confirm coverage and reimbursement policies. For more information on TriNav, visit www.trinavinfusion. com, or call +1-888-321-5212.

References 1. Remarks of Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma to the Medical Device Manufacturers Association (MDMA) Annual Meeting (5/2/2019).

2. Gustafson, TA. ASC Focus. 2015 Sept:8-9.

3. Titano JJ, et al. Cardiovasc Intervent Radiol. 2019;42:560-568. * Study design: A retrospective, single-centre study included 88 treatment-naive patients with solitary HCC tumours <6.5cm who underwent treatment utilising either PEDD™ (n=18) or standard EH microcatheters (n=70).

Twenty-three patients (5 PEDD™, 18 EH) received a liver transplant during the study, with 1 PEDD™ and six EH patients excluded from the tumour necrosis analysis for receiving subsequent therapies prior to transplant. A pathologist performed a blinded review of the liver explant specimens to assess tumour necrosis and treatment distribution. Percentage necrosis was defined as the volume of necrotic areas divided by the total tumour volume.

4. Pasciak AS, et al. J Vasc Interv Radiol. 2015;26:660-669. *Study design: Sequential lobar infusion of 99mTc MAA in nine patients prior to 90Y treatment with PEDD™ and conventional microcatheter.

5. Durham ED, et al. J Vasc Interv Radiol. 2015;26:e54 (Poster 18).

6. Kim AY, et al. PloS One. 2017;12(9):e0183861. DOI: 10.1371/journal.pone.0183861.

7. O’Hara R. Poster presented at: European Conference on Interventional Oncology (ECIO); April 22-25, 2018; Vienna, Austria.

8. Data on file (510K). TriSalus Life Sciences, 2019.

9. TriSalus TriNav™ Infusion System, Instructions for Use.

NEW TriNav™ Infusion System: Introducing improved technology for the proprietary PEDD™ approach. Engineered for improved selectivity.8 None of the above statements are intended to imply a CMS endorsement of TriNav or any other product. The coding information provided is gathered from various resources, is general in nature, and is subject to change without notice. The provider is responsible for determining the appropriate health care setting and submitting accurate claims for products and services rendered. Providers should contact third-party payers for specific information on their coding, coverage, and payment policies. The TriNav Infusion System is available for sale in the USA. This product has not been approved for sale outside the USA. Contraindications: TriNav is not intended for use in the vasculature of the central nervous system (including the neurovasculature) or central circulatory system (including the coronary vasculature). Intended Use: TriNav is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.9

12

New data for AV access

Positive new data for AV access interventions released New arteriovenous (AV) access results were presented at the 2020 Leipzig Interventional Course (LINC; 28–31 January, Leipzig, Germany), including data on percutaneous AV fistula creation and the use of drug-coated balloons (DCBs) in AV access interventions.

While Robert Jones (University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK) opened the session by revealing a high functional patency for endovascular AV fistulae (endoAVF) at six months, Andrew Holden (Auckland University School of Medicine, Auckland, New Zealand) revealed a sustained patency advantage for a DCB compared to percutaneous transluminal angioplasty (PTA).

EndoAVF shows high functional patency at six months

Jones opened the session by presenting

March 2020 | Issue 77 initial multicentre experience results of the WavelinQ catheter (BD). Concluding that “AV is now endovascular,” results of an EU and Canada post-market study showed 95% functional patency at six months, as well as a limited need for secondary procedures.

“This is the first time that this additional data on the multicentre WavelinQ study has been seen,” Jones began. EndoAVF devices—created with the intention of improving fistula outcomes—have performed well in clinical studies. “There are high rates of technical success in terms of creation, higher rates of maturation and patency, and low rates of complications. But we have got to bear in mind that these closely monitored clinical trials are not the real world,” Jones commented.

At the University Hospitals Birmingham NHS Foundation Trust, Jones and colleagues carried out a matched comparison of 30 WavelinQ fistulas with 40 surgical fistulaes. Patency results showed that WavelinQ fistulaes outperformed those created surgically.

In terms of the post-market study, this was intended to collect data on WavelinQ catheter performance and outcomes in a prospective, multicentre, international study, which recruited 100 patients across 13 sites in the EU and Canada. Jones remarked: “The post-market study forms part of a wider programme of clinical trials looking at the WavelinQ device, most of which have already been either completed or published”.

Jones concluded: “In summary, this is

WavelinQ (BD)

the first time that this post-market data is being seen. We have got 95% functional patency at six months with a limited need for secondary reinterventions.”

DCB shows sustained patency advantage over PTA

Subsequently, Holden presented 12-month outcomes of the IN.PACT AV Access study, showing a 63.8% target lesion primary patency in the DCB arm compared to 43.6% in the PTA arm, with no difference in mortality.

The AV Access investigational device exemption (IDE) trial was designed to evaluate the safety and effectiveness of the IN.PACT AV DCB compared to PTA for de novo or restenotic obstructive lesions of native AV fistulae in the upper limbs. This was performed in the USA, Japan, and New Zealand.

A total of 330 patients were randomised 1:1. The primary safety endpoint was serious adverse event rate within 30 days and primary effectiveness endpoint was target lesion primary patency through six months, which is defined as freedom from clinically-driven

target lesion revascularisation (CD-TLR) or access circuit thrombosis measured to six months post-procedure.

It was revealed last year that IN.PACT AV Access was the first DCB versus angioplasty trial to meet its primary effectiveness endpoint—a “highly impressive” primary patency of 82.2% at six months compared to 59.5% with PTA with high statistical significance and also a significant advantage in terms of freedom from CD-TLR. “I am delighted to share, for the first time, the 12-month primary effectiveness endpoint. Again, a highly significant difference in target lesion primary patency—63.8% in the DCB arm compared to 43.6% for the PTA arm,” Holden revealed, adding that “there was also a highly significant difference in CD-TLR, at 35% in the DCB arm and 54.3% in the PTA arm”.

Holden added that there was less than half the rate of access circuit thrombosis in the DCB arm. “This is such a severe and catastrophic complication that, even though it did not reach clinical significance, I think is worth mentioning”.

In terms of safety at 12 months, the serious adverse event rate for the DCB arm was 46.9% compared to 69.2% for the PTA group. In the DCB arm, 40.1% had lesion revascularisations compared to 62.4% in PTA arm. Holden added that there is “absolutely no mortality signal between the two groups at 12 months,” detailing that freedom from all-cause mortality in DCB arm was 90.6% and in the PTA arm was 90.4%.

Improved patient outcomes with DCBs in AV access may afford “substantive” savings Based on 12-month outcomes of the IN.PACT arteriovenous (AV) Access trial, improved patient outcomes are expected to lead to significant per patient and healthcare delivery savings out to three year follow-up. This was the conclusion of Robert Lookstein (The Mount Sinai Hospital, New York, USA) at this year’s Leipzig Interventional Course (LINC 2020; 28–31 January, Leipzig, Germany).

L

ookstein, co-principal investigator of the trial, was presenting results of an economic analysis of the use of the IN.PACT drug-coated balloon (DCB) versus plain balloon angioplasty in both the German and US healthcare systems. Data for the budget impact model was extrapolated from 12-month outcomes of the IN.PACT AV Access trial, presented for the first time by Andrew Holden (Auckland University School of Medicine, Auckland, New Zealand) at LINC 2020. The group of patients included in the economic analysis were assembled at the trial’s inception.

“If we look at CMS [Centers for Medicare and Medicaid Services] data from as recently 2017, there are just under half a million patients in the USA and approximately 75,000 patients in Germany that are receiving haemodialysis,” Lookstein began, adding that the preferred method of receiving haemodialysis is through fistulaes or grafts, particularly in the upper extremity. However, he noted, these interventions are “fraught with high rates of dysfunction and requirement of procedures to maintain patency”. The IN.PACT AV DCB may address this, with 12-month IN.PACT AV Access outcomes demonstrating the safety and clinical benefit of the DCB compared to balloon angioplasty for dysfunctional native arteriovenous fistulaes.

Lookstein detailed that he and his colleagues’

approach to the economic analysis was a decision analytic markov model. “We captured the index procedure rates of reintervention and projected vascular access management cost based on not only the 12-month data, but also data projected out to 36 months using reintervention as a constant hazard,” he elaborated.

The group then compounded that, using the cost data referenced from the current 2020 fee schedules, based on the inpatient DRG (diagnosis related group) payment schemes for Germany, and on the facility and physician fee schedules in the USA. Reiterating the 12-month IN.PACT AV Access data, Lookstein noted that the number of reinterventions required to maintain access circuit patency at 12 months was approximately 0.65 per patient, whereas the figure for plain balloon angioplasty was 1.05. He added that this translated to an access circuit primary patency of 53.8% at 12 months in the DCB group, compared to 32.4% for the plain balloon angioplasty cohort.

Lookstein detailed that, in the economic analysis, the group incorporated the fact that the mean number of DCBs used per procedure was 1.23, and also acknowledged a greater mortality rate for the end stage renal disease population.

In terms of the fee schedule the group used, the figure is just over €3,000 for a plain balloon angioplasty in a

dialysis access circuit, which increases slightly based on incremental reimbursement in the German healthcare system. For a reintervention, the cost is just over €3,400, taking into consideration a 10% incidence of stent placement or surgical reintervention.

Looking at the US model, the figures are US$3,100 for plain balloon angioplasty, with no additional costs in the US health system for the use of DCBs. The cost of a reintervention is US$3,475, incorporating again a 10% incidence of stent placement or thrombectomy or surgical reintervention as observed in the IN.PACT AV Access trial.

In the German healthcare system, the 12-month IN.PACT AV Access data corresponded to a saving at the six-month follow-up of over €1,000. At 36-month follow-up, the figure increases to €3,300 saving seen per patient. Based on the same modelling for the US healthcare delivery system, Lookstein and colleagues reported a US$1,300 saving at the 12-month time point and a US$3,500 saving at the 36-month time point.

Lookstein noted that, based on the costs of DCBs in the USA, which is not currently reimbursed, “there is a cost-neutral, or break-even strategy at approximately the two-year time point”.

Lookstein concluded: “Based on the 12-month IN.PACT AV Access data, improved patient outcomes are expected to lead to substantive per patient and healthcare delivery savings out to three-year followup, with the savings actually increasing as the analysis translates from 12 months out to 36 months. The reductions in reinterventions observed not only reduce patient morbidity but improve their quality of life.”

14

Myomectomy versus UAE

March 2020 | Issue 77

The pros and cons of uterine artery embolization discussed at Spectrum Addressing the audience at the Spectrum meeting (18–21 January, Miami, USA), Theresa Caridi (MedStar Georgetown University Hospital, Washington, DC, USA) expands on the pros and cons of uterine artery embolization (UAE), and shares what factors she believes are necessary to discuss with the patient prior to the procedure.

F

irstly, Caridi discussed the issue of fertility.

In a 2008 study published in the Journal of Cardiovascular and Interventional Radiology (CVIR) by Michal Mara (General Faculty Hospital and First Medical Faculty of Charles University, Prague, Czech Republic) et al, the authors concluded that, while UAE is less invasive and as symptomatically effective and safe as myomectomy, it has inferior reproductive outcomes in the first two years after treatment. Onehundred-and-twenty-one women with reproductive plans who presented with an intramural fibroid(s) larger than 4cm were randomly selected for either UAE or myomectomy; 58 embolizations and 63 myomectomies (42 laparoscopic, 21 open) were performed. Mara et al reported significantly more pregnancies and labours (33 and 19, respectively) and fewer abortions (six) following surgery than after embolization (17 pregnancies, five labours, nine abortions; p<0.05).

Listing her first positive for UAE, Caridi told the Spectrum audience how the procedure is uterinesparing. Citing a study by Shannon Laughlin-Tommaso (Mayo Clinic, Rochester, USA) published in Menopause in 2018, Caridi demonstrated that ovarian-sparing hysterectomy, which had been touted as a potential way of avoiding some of the detrimental effects of hysterectomy, did not fully eliminate the risks. The Menopause study looked at approximately 2,000 women who had an ovarian-sparing hysterectomy and compared them to age-matched controls. Laughlin-Tommaso and colleagues found that even with ovarian conservation, there is an elevated long-term risk of cardiovascular disease and metabolic conditions, especially in women who undergo hysterectomy when 35 or younger. The authors concluded: “If these associations are causal, alternatives to hysterectomy should be considered to treat benign gynaecologic conditions.”

“Women are talking about this on social media,” Caridi commented. “They are asking ‘What are the risks if I have a hysterectomy, even if I leave the ovaries behind?’ I think it is important to know about this.”

However, while UAE offers a uterine-sparing alternative to hysterectomy, Caridi said that the presence of the uterus “means that we can get fibroid recurrence”. Sharing the five-year results of the prospective, randomised controlled REST trial, which directly compared UAE to surgical treatments—both myomectomy and hysterectomy—in patients with symptomatic uterine fibroids, Caridi reported how the authors, Jon Moss (Gartnavel General Hospital, Glasgow, UK) et al, found that adverse event rates were no different between the UAE and surgical arms, but that the reintervention rate was much higher with UAE. Moss and colleagues’ conclusion in 2011 was that “UAE is a satisfactory alternative to surgery for fibroids”, but that “the less invasive nature of UAE needs to be balanced against the need for re-intervention in almost a third of patients”. They recommended that the choice should lie with the informed patient.

In defence of UAE, Caridi added: “That being said, some of those people who got surgery actually got a hysterectomy, so of course they are not going to need a reintervention more than likely, whereas people who get a myomectomy may, so there is a little bit of bias. But several studies, some out to ten years, do show that the reintervention rate with UAE is about 30%.”

Moving on to her next pro of UAE, Caridi said:

“UAE is very efficacious. In fact, it is one of the most efficacious procedures we do in interventional radiology (IR).” The clinical practice guidelines from the Society of Interventional Radiology (SIR) summarise the data in the literature, and show that, on average, “rates of success are really good”: leiomyoma size reduction, 50– 60%; uterine size reduction, 40–50%; reduction of bulk symptoms, 88–92%; elimination of abnormal uterine bleeding, >90%; successful elimination of symptoms,

Returning to her pros of UAE list, Caridi said that “probably one of the key reasons why women seek” UAE is that the recovery time is shorter than for surgical intervention. In the CVIR study by Mara and colleagues that demonstrated the inferior reproductive outcomes of UAE when compared with myomectomy, the authors also reported that the minimally-invasive option fared much better than myomectomy, with significance, for average length of hospital stay, recovery period, and disability greater than two weeks. “It is a quicker recovery, no doubt,” Caridi stated.

She continued, “Though there is a lot of pain associated with UAE”. She elaborated: “Despite our best efforts to look into this in many ways, and all the research that has been done—we have this arsenal of anti-inflammatory and PCA [patient-controlled analgesia] medications, [but] more than 90% of women still report post-procedural pain, and about 35% of women experience pain that is equal to or greater than [that experienced in] labour. So this is a real issue.

“In terms of how to mitigate this, we have some adjunctive techniques, but some of them require a

Theresa Caridi presenting at Spectrum 2020

Women are talking about this on social media. They are asking ‘What are the risks if I have a hysterectomy?’”

75%; patient satisfaction (would recommend UAE to a friend), 80–90%.

However, another con of UAE is the possibility of fibroid passage. “We treat fibroids really well, but sometimes they detach and pass,” Caridi explained. “We have to worry about that, particularly in submucosal fibroids.”

A meta-analysis from Sundeep Toor (The Ottawa Hospital and University of Ottawa, Ottawa, Canada) et al published in the American Journal of Roentgenology in 2012 reported an incidence of leiomyoma tissue passage of 4.7% (with a range of 3.9–5.7% in 8,159 patients). “That is much higher in a risky site like the submucosal location,” Caridi commented. “It is something we have to worry about. What is the consequence of this [fibroid passage]? Patients can get endometritis and infection and require a secondary intervention. Maybe it is a myomectomy, maybe it is a hysterectomy, if you cannot get the infection under control. Or, they can just get a chronic vaginal discharge that lasts upwards of six months or even a year, and some would like to have a hysterectomy for that reason.”

second procedure or have their own risks. We could use superior hypogastric nerve block, intra-arterial lidocaine after embolization—this is pretty widely used as its low-risk profile has been shown in a prospective randomised controlled trial—and then you could go as far as to perform an epidural if you cannot get the pain under control.”

Informed consent is key

Concluding, Caridi commented: “All that being said, I think the summary of this lecture is that there are a lot of pros and a lot of cons to doing a UAE, but the most important factor is to discuss these in a clinic visit.”

Caridi showed the Spectrum audience a consent form that she uses in her own institution, Georgetown University Hospital, that she said she would be happy to share with any interested parties. “We go over all these things with the patient,” she explained. “It helps me stay on track. I sign it, they sign it, I give them a copy.”

The form covers a description of the procedure and the anticipated outcomes: “I tell them [the patient] this is a global treatment, it is uterine-sparing, it is about 90% efficacious, the recovery time is limited. I tell them to take a week off work, although they oftentimes do not need it, but at least they have planned ahead.

“We talk about the alternatives. We talk about the risks, some of which—but this is not an inclusive list— are fibroid recurrence, passage, and pain. Then we talk about future fertility, this actually has its own category.

There is no guarantee for future fertility, and if someone desires that, we certainly talk about whether they are a myomectomy candidate.”

Prostate artery embolization

Issue 77 | March 2020

PAE “far superior” to a sham procedure for benign prostatic hyperplasia, new study published in European Urology finds The improvements in quality of life measurements and International Prostate Symptom Score (IPSS) in patients following prostatic artery embolization (PAE) are “far superior” to those due to the placebo effect, a new study just published in European Urology, the official journal of the European Association of Urology (EAU), concludes. Publishing a paper positively describing PAE in a urology journal has historically been difficult for interventional radiologists, and co-author Tiago Bilhim (Hôpital Saint-Louis, Lisbon, Portugal) tells Interventional News that this publication “might help our way into the urology guidelines with PAE”.

T

he most recent EAU guidelines for the diagnosis and treatment of men with lower urinary tract symptoms (LUTS)/ benign prostatic hyperplasia (BPH), published in 2017, are cautious when describing the potential clinical role of PAE, saying that the selection of LUTS patients who will benefit from the procedure still needs to be defined, and highlighting that PAE is technically demanding. The European guidelines state: “A multidisciplinary team approach of urologists and radiologists is mandatory as the basis for future RCTs [randomised controlled trials] of good quality with long-term follow-up in order to integrate this treatment option into the spectrum of efficient, minimally invasive treatment options.”

Bilhim says that the present study is the “kind of research” called for by the European urology community in order to accept PAE into their guidelines for the treatment of LUTS due to BPH. He therefore hopes that this research, which he says demonstrates that PAE is not a placebo procedure, “will be a fundamental study to raise the level of evidence of PAE to treat LUTS due to BPH, and to help get PAE in the [European] urology guidelines.”

In the USA, the American Urological Association (AUA) also mention PAE in their guidelines, published in The Journal of Urology—but only to explicitly not recommend the procedure outside the context of a clinical trial. Interventional radiologists have been advocating for the procedure’s acceptance by urologists, with several prominent figures in this community calling for more widespread awareness of the safety and efficacy of this minimally invasive treatment option for select LUTS/ BPH patients.

The authors of this recent publication therefore underline the importance of sharing their data with the urology community, writing: “PAE is considered experimental in the urology guidelines.

For a novel technique such as PAE to be considered as a first-line option, shamcontrolled trials are very helpful, and hence the present study.”

In light of the positive outcomes observed in the PAE group, they believe “The results of this clinical trial will be a reference for future research consensus panels and guidelines on the management of LUTS/BPH.” Speaking to this newspaper in May 2019, Ari Isaacson (Department of Radiology, University of North Carolina, Chapel Hill, USA) highlighted the importance of interventional radiologists publishing their work in urology specific journals, as a way of communicating their views

getting accepted into a urology journal was the most difficult, challenging, controversial process I have ever been through. The reviews were replete with opinions that seemed to have been made before even reading the study. We tried several times, and finally got accepted into the fourth urology journal. This was a prospective, phase II, FDA [US Food and Drug Administration]-approved study, so it met all the high level criteria, but it was still dismissed by many urology journals.”

However, the European urology community has been more welcoming, as Bilhim describes. “The overall experience was very positive,” he says. “We received very constructive reviews from urology experts in the field of BPH that helped make the manuscript better. We wanted to target the urology community because the major goal of this manuscript was to prove to the urology community that PAE is not a sham procedure, and is in fact safe and effective for the treatment of LUTS, without compromising sexual function.

“The major goal of this study was to raise the level of evidence for PAE as a safe technique to treat LUTS due to BPH, so that PAE can be considered as [an] effective alternative in the urological guidelines for patient management. The submission process in the urology journal was similar to standard scientific journals and it took around four to six months from submission to final acceptance.”

Lead author João Pisco (Hôpital SaintLouis, Lisbon, Portugal), who died in March 2019 after completion of the trial, and co-authors set out to assess the safety and efficacy of PAE “above and beyond the placebo effect” compared with a sham

Lead author João Pisco (L) and Tiago Bilhim

[I hope this] will be a fundamental study to raise the level of evidence of PAE to treat LUTS due to BPH, and to help get PAE in the urology guidelines.” directly to this community. However, he reported that this is challenging: “We have attempted to [publish in a urology journal] several times; it is very difficult to get a PAE paper in a urology journal”. Riad Salem (Northwestern University, Chicago, USA), who is one of few US interventional radiologists that has published a PAE paper in a urology journal, supports this assertion, commenting earlier this year: “In my 20 years of publishing over 330 papers,

procedure for the treatment of LUTS/ BPH. They conducted a parallel-group, single-blind, sham-controlled superiority randomised clinical trial in 80 men, aged 45 or above, with severe LUTS/BPH non-responsive to medical treatment between 2 September 2014 and 3 March 2018 at Hôpital Saint-Louis, Lisbon, Portugal, with an efficacy assessment at six months after randomisation. This was followed by an open extension phase, where all 38 patients of the sham trial arm

17

who completed the single-blind period crossed over to the PAE arm (underwent the procedure). A final evaluation was conducted at 12 months after randomisation. One patient in the PAE group and three in the sham group did not complete the study.

Patients were randomised 1:1 upon successful catheterisation of a prostatic artery to either PAE or a sham PAE procedure without embolisation. Pisco and colleagues describe the procedure: “In the PAE group, Bead Block (BTG plc, London, UK) 300–500mm was used; in the sham group, after catheterisation of one prostatic artery, the catheter was removed and no particles were injected, but there was a wait of some minutes before the removal of the catheter in order to avoid revealing the treatment arm to patients of the sham group.”

All procedures were performed by five interventional radiologists with between three and 10 years of experience in PAE. The investigators performed an intention-to-treat analysis of all randomised patients. The co-primary outcomes were the change from baseline to six months in the IPSS and the quality of life score at six months, analysed with analysis of covariance and t-test, respectively.

At six months, patients in the PAE arm had a greater improvement in IPSS than patients in the sham arm.

For those that underwent PAE, the decrease from baseline to month six in IPSS was 17.1±7.25. In comparison, the decrease in IPSS from baseline to six months for patients who underwent the sham procedure was only 5.03±8.13 (difference between groups in changes from baseline: 13.2, 95% confidence interval [CI]: 10.2–16.2, p<0.0001).

After six months, the mean IPSS in the PAE group was 8.75±5.73, and 21.9±7.34 in the sham arm.

This pattern was also true of improvements in quality of life: for patients treated with PAE, mean quality of life score at six months was 3.48±1.38, while for patients treated with the sham procedure, mean quality of life score at six months was 1.35±1.12 (difference in the means of quality of life scores between groups at month six: 2.13, 95% CI: 1.57–2.68, p<0.0001).

The occurrence of adverse events was similar between the two groups: 16 events in 14 patients (35%) after PAE, and 17 events in 13 patients (32.5%) following the sham procedure. One serious adverse event took place in the sham group during the open period.

“The results of this randomised clinical trial provide clear evidence that the improvement experienced by patients after PAE is due to a real treatment effect that is much larger than the placebo effect associated with the procedure,” Pisco et al summarise. “The marked and sustained amelioration in all primary and secondary outcomes, with no negative influence on erectile function, offers strong evidence that PAE, through the reduction it imposes on prostate size and possibly because of several other mechanisms, actually modifies the course of LUTS/BPH, and this explains the high clinical success rates reported so far with this treatment.”

18

Interview

March 2020 | Issue 77

Profile

Matthew Johnson

Inspired by his father, an interventional radiologist who used to shape catheters over the stove at home, Matthew Johnson switched from a residency in surgery to pursue a career in interventional oncology, and began a lifelong love affair with the liver. “There is always more to learn”, he says.

What first attracted you to interventional radiology (IR)?

My father. He was a radiologist, radiation oncologist, and interventional radiologist in private practice in Battle Creek, Michigan, USA. He loved his job, and often spoke about his patients, mostly about his cancer patients. I once suggested that it must be difficult treating cancer patients, but he said “No; it is incredibly satisfying. There are two things you can cure in medicine: infection and cancer.”

That positivity has always stuck with me. He did the first arteriogram in Battle Creek, but I did not know that until I was in medical school. I remembered that he used to shape catheters over the stove at home, but did not know that was unusual. It is what Dad did. After medical school, I started residency in surgery, following my brother, Mike.

My father thought I was crazy. He said that I should be a radiologist. He was right. I switched to Radiology after two years in surgery, always with the intention of becoming an interventional radiologist.

Have you had important mentors throughout your career? What have they taught you?

My father and my brother Mike both taught me the importance of doing the work. Both led by example.

The adages that “99% of life is showing up” and “do what you say you are going to do” were family mantras.

Mike, two years ahead of me in medical school, and still a practicing surgeon, told me that as a resident, no matter how difficult your day was, you should study for an hour.

He did that, all the way through his residency. While I was not 100% successful in matching his effort (his drive is unparalleled), I did understand the concept, and tried to adhere to it. I still do, even if sometimes that study is of ancient history rather than of the latest anticoagulant: there is always more to learn.

I have had many, many other mentors, including Rogelio Moncada, Leon Love, Terry Demos, and Richard Cooper at Loyola in Chicago. All were brilliant and all worked hard. They stressed and accepted only excellence, and were the best teachers. Tony Venbrux, part of the faculty at Johns Hopkins during my fellowship, demonstrated not only knowledge and ability, but unequalled empathy and kindness. I continue to strive to be more like Tony. Scott Trerotola, IR section head at IU when I joined and my chief for eight years, taught me how to be a researcher. His refusal to sacrifice his integrity was inspiring. Finally, in an inexhaustive list, and although he would be surprised to hear it (as he was a radiology resident when I joined the faculty at IU), I consider Himanshu Shah, my current chair, as a mentor.

His always-positive demeanour, openness to discussion, keen intellect, and indefatigable spirit have made IU Radiology a wonderful department in which to work, one that continues to flourish under his stewardship.

What has been the highlight of your term as secretary of the Society of Interventional Radiology (SIR) this year?

Unquestionably, that as we have matured as a society and embraced the fact that we are now a primary specialty, we have recognised the importance of demonstrating to the world the value of what we provide to patients. That recognition has led to us having a robust strategic plan that includes supporting interventional radiologists in

practice, and creating and maintaining a residency that trains excellent clinical physicians, as well as improving understanding by external groups of what IR is. The fourth pillar of that strategic plan excites me most: it is directed toward improving the quality and impact of IR research. We have grown the research infrastructure within SIR by adding staff experience (for example, a new methodologist) and undertaking advanced clinical practice guideline initiatives. The first SIR-sponsored Clinical Practice Guideline on IVC filter use will be published in the next few months, and two others will begin this year. We have also directed ample resources to support the growth of our registries to be used for both quality improvement efforts and original research. I am very excited about the shared commitment by SIR and the SIR Foundation to research, as I think that support is essential to the continuing success of our specialty.

What is the next thing that will really make a difference? I would like to contribute to the creation of that change-maker.”

You are co-principal investigator of the PRESERVE trial, the largest prospective study investigating real-world outcomes with contemporary use of IVC filters.

Why is this study important?

It is important because it will give us the best data we can obtain regarding IVC [inferior vena cava] filter use in the USA. A randomised controlled trial is not really feasible, because of the impossibility of an appropriate control group: if that group is anticoagulated, it does not represent patients for whom filters are indicated; if that group is not anticoagulated, those patients are subjected (we believe) to increased risk of pulmonary embolus (PE). PRESERVE is designed to follow patients with filters until filter removal or for two years. With over 1,400 subjects, we will be able to evaluate real complication risks and incidences of PE before and after filter removal. We will begin evaluation of the results in May 2020, after all patients have completed one-year follow up or have had their filters removed. I hope and believe that PRESERVE will contribute greatly to our understanding of how filters are used, and will help to demonstrate who will benefit most from their use. As follow-up of patients with IVC filters is so important, I am hopeful that the structured follow-up we employed in PRESERVE will serve as a paradigm for such followup in clinical practice.

The PRESERVE trial is the result of a multi-stakeholder collaboration.

What have you learnt from this?

The PRESERVE trial is a collaboration between SIR, the Society for Vascular Surgery (SVS), the US Food and Drug Administration (FDA), and industry partners. I think that that collaboration is one of the major benefits of PRESERVE. The trial was made possible by a

shared goal: wanting to do what is best for our patients.

We all recognised that the data surrounding venous thromboembolic disease in general, and especially around IVC filters, are limited, that we do not know who will benefit most from filter placement, how long to leave that filter in place, and how to follow it while it is there. PRESERVE has demonstrated that each of the entities involved has unique strengths—including skills, infrastructure, networks, understanding—and that as we work toward our shared goal, the sum of those combined strengths is greater than their components. I hope PRESERVE can serve as a paradigm for other SIR collaborative efforts.

You hold a number of patents.

What drives you to innovate, and why specifically in the field of drug delivery?

There is always something more to learn. History repeatedly demonstrates the need for continuing

Interview

Issue 77 | March 2020

19

Fact File

Current positions

2020–Present: President-elect, Society of

Interventional Radiology (SIR) 2019–2020: Secretary, SIR 2016–Present: Gary J Becker Professor of Radiology Research, IU School of Medicine, Indianapolis, USA 2016–Present: Director, Clinical Research, Department of Radiology and Imaging Sciences, Indiana University Health, Indianapolis, USA 2012–Present: Director, Interventional Oncology, Indiana University Health, Indianapolis, USA 2011–Present: Co-primary investigator, PRESERVE (PREdicting Safety and Efficacy of inferioR VEna cava filters) study 2007–Present: Professor of Radiology and Surgery, Indiana University (IU) School of Medicine, Indianapolis, USA

Education

innovation. Indeed, innovations changed the world: the stirrup changed warfare, the printing press changed thought. Happily, IR has always been immersed in innovation. That that process continues apace demonstrates how much more there is to improve.

My clinical focus in the treatment of people with liver tumours led me to investigate ways to improve delivery of bioactive agents to those tumours. Our understanding of locoregional delivery of those agents is in its infancy, which is very exciting. What is the next thing that will really make a difference? I would like to contribute to the creation of that change-maker, to hear of a person whose life was made better by it.

Which innovations have most influenced your career, and how?

Transarterial radioembolization (TARE). Prior to the advent of TARE, my involvement in the treatment of patients with cancer was without much focus. When I considered treating patients with TARE, I thought that in order to provide adequate care to my patients, I

would need to devote myself to interventional oncology (IO). So, prior to adding TARE to my practice, I spent a considerable amount of time learning about the treatment of patients with liver tumours. Not just IR treatments, but all possible treatments. It took me a few years to be somewhat comfortable with those treatment algorithms, but it was well worth it. That study made me a much better interventional oncologist, not just when I choose to use TARE for a particular patient, but also when I choose transarterial chemoembolization (TACE) or another locoregional therapy, or when I choose instead to refer to another doctors in our multidisciplinary team. I thank my IR partners at IU, as they allowed me the time to focus on IO. I am very grateful for their unwavering support.

What are your hobbies and interests outside of medicine?

Mainly spending time with my family: my wife, Cynthia, and I have four children, all now adults with their own partners, and one grandson, Wesley. My hobbies include cycling, running, and rowing (machine); ancient history, from the beginning of civilization to the Reformation, focusing primarily on the Roman republic and empire; playing and listening to music: I played piano and cello growing up, still play piano, and I took up guitar when I was 50 (I am not very good), and Cynthia and I very much enjoy going to concerts; and travel, which I very much enjoy when my wife is with me.

1992–1994: Fellowship in IR, Johns Hopkins University School of Medicine, Baltimore, USA 1988–1992: Residency in Diagnostic Radiology, Loyola University, Chicago, USA 1986–1988: Residency in General Surgery, Loyola University, Chicago, USA 1983–1986: MD, University of Michigan, Ann Arbor, USA 1981–1983: Liaison Program, University of Michigan, Ann Arbor, USA 1979–1983: Honors Program, University of Michigan, Ann Arbor, USA

Past society positions (selected)

2019–2020: Treasurer, SIR 2011–2016: Membership Services Councillor, SIR 2011–2013: Chair, FDA committee and SIRFDA device forum, SIR 2009: Chair, Annual scientific meeting, SIR 2000–2007: Roster of Distinguished Scientific Advisors for grant reviews, Radiological Society of North America 2000–2006: Member, Peripheral Vascular Imaging and Intervention Committee, American Heart Association

Healthcare entrepreneurship

Issue 77 | March 2020

“Innovation is a learnable skill”: ISET keynote encourages interventionalists to get creative “Innovation, at least a good component of it, is a learnable and a scientific skill,” Srikant Datar, Arthur Lowes Dickinson professor of Business Administration at Harvard University, and leader of Innovation at the Harvard Business School, Cambridge, USA, told delegates at the 32nd Annual International Symposium on Endovascular Therapy (ISET; 22–25 January, Hollywood, USA).

“We typically think of it as strokes of genius, but if you want organisations to be innovative, that can be done. Our research over the past 10 or 15 years suggest that is possible.”

D

efining innovation as “a product, process, or model that is novel and useful”, Datar went on to detail steps interventionalists could take to be more innovative in their daily practice.

“There are two worlds that we all live in,” he declared: “The operational world, and the innovation world. […]

The way in which we think of the operational world is very different to the way in which we think of the operational world.” Words such as “rules”, “routines”, “procedures”, and “decisionmaking”, he said, are associated with the operational world—the one where actions are taken to make things happen.

“Those very ways of thinking come in the way of innovating,” he claimed.

Words like “curiosity”, “connectionmaking”, “developmental thinking”, and “experimenting” belong to the innovation world, according to Datar.

As different skills and different ways of thinking are required in both realms, the keynote speaker stressed the importance of “keeping both worlds separate”.

Delving into a more granular explanation, Datar expanded: “When I am in the operational world, I can move quickly from problem to solution.

What we argue—and this is why the innovation world is different—[is that] you cannot go quickly from problem to solution, you have to take a little bit of a curved path.” This, he explained, takes the problem-seeker from the “concrete realm”—where the problem exists—to the “abstract realm”—where imagination is necessary, and where the thinker can innovate. The solution returns the problem-solver once more to the “concrete world”.

Those confronted with a problem have to ask themselves the following questions, he said: How do you make deep observations?

How do you convert observations into insights?

How do you frame and reframe problems?

How can you come up with ideas systematically?

How can you develop those concepts to come up with the solution?

In the innovation programme Datar runs at Harvard University, there are four stages to this problem-to-solution trajectory. These are to clarify, ideate, develop, and implement. When following this protocol, the innovator is following a “human-centred design” approach, according to Datar.

Clarify the problem

Pivotal to a human-centred design is that the product or solution is built out from the needs of users and patients.

It is therefore crucial to identify “pain points”: a moment when a user or patient experiences frustration, difficulty, or uncertainty when using a product or service. A pain point indicates an unmet user need.

“Though many pain points are explicit,” Datar said, “it is the implicit

interactions described?

Users: Who are the users?

Using a case study to illustrate this, Datar talked to the conference audience about Jaipur Limb, a not-for-profit hospital in India that fits prosthetic limbs for free on patients who have lost a part of their leg. “The goal is to serve both rich and poor patients. The question we ask is ‘What problem is Jaipur Limb solving?’ The answer that most of us come to very quickly is that it is solving the problem of how to restore mobility.

Obviously a very important problem to solve.

“DR Mehta, founder of Jaipur Limb, uses this technique called ‘How might we…’, which is an approach to phrasing problem statements that invites broad exploration. Should we just think about mobility, or should we be thinking about something else?

a new task is assigned to an existing resource. “Look at all tools that are available to you, and arbitrarily assign new tasks to them,” Datar advised.

“For instance, assign to the ambulance tasks for in the emergency room.” He cites Uber and Airbnb as two successful business that are based on this model: “There are some phenomenal examples that have come from task unification, Uber and Airbnb being the two best examples: taking resources that we each own, our cars, our houses, and assigning them a different task, to be a taxi service or a hotel.”

Describing other types of fixedness, Datar references “structural fixedness”: the tendency to think of an object or process as a whole, with a defined structure that cannot be modified, divided, or rearranged. “Break it up!” he suggested. “Take a part of your process that comes later and move it up in front.

See if you can find an advantage to your patient or the way that healthcare is provided.”

Develop

Srikant Datar

And he very quickly concluded that for these patients, the problem was not restoring mobility, but restoring dignity.

He then ends up innovating in many different ways. These are the implicit, latent pain points I was referring to earlier, where you are trying to make patients feel good about themselves.

They have multiple innovations [for this]—from how patients are looked after when they arrive at the hospital

We are all used to fixed ways of thinking. We live life very comfortably with functional fixedness, [...] but it is a barrier in the innovation world.” or latent pain points that I want to emphasise, because that is where a large amount of benefits from innovations come. When you can innovate in a way where people feel good about the innovation, rather than something they just have to accept.”

Identifying these pain points systematically is possible, Datar said, and can be done using the “AEIOU” protocol: Activities: What is happening?

Environments: Where are things happening?

Interactions: Who is doing what with whom? Do interactions seem planned or spur of the moment?

Objects: What objects are present and/or involved in activities and

21

(meals, admit without appointment 24 hours a day) to how they can be helped to earn a livelihood after they are fitted with prosthetics (tea stall kits, skill development).”

Ideate

“We are all used to fixed ways of thinking,” Datar stated. One example is “functional fixedness”—a cognitive bias that limits a person to using an object only in the way it is traditionally used.

“We live life very comfortably with functional fixedness. It is a good thing to have when in the operational world. It is a barrier in the innovation world.”

Task unification is the method advocated for by the Harvard group as a way of breaking this fixedness, where

To transition from the abstract to the concrete realm, Datar emphasised the importance of prototyping. “Prototyping simply means running a model for facilitating learning. Prototypes help to test critical questions and explore assumptions. The goal is to learn about a specific concept or sub-parts of a concept as quickly as possible, and at low cost.”

To prototype an innovation, Datar told delegates they need to: Identify critical assumptions in your concept around desirability, feasibility, or viability Clarify what you would like to learn about the assumption Design a cheap and fast experiment that will help you learn

Implement

Finally, Datar turned his attention to the team that will implement the innovation in the real world. He recommends using the FourSight model, which involves reflecting on people’s different strengths and ways of thinking. “Ask people for their preferences on assertiveness,” he counselled. “Are they divergent thinkers or convergent thinkers?” Plotting assertiveness on the y axis (a spectrum of “Ask” to “State”) and way of thinking on the x axis (from “Divergent” to “Convergent”), Datar presents a box divided into four, representing four types of people. He encouraged his listeners to have at least one per type in the group.

“The ones that are ask/diverge will help you clarify; the ones that are state/ diverge will help you ideate; the ones that are ask/converge will help you develop; and the ones that are state/converge will help you implement,” he explained. “Of course, getting these people to work together is a big challenge, because people across these diagonals cannot stand each other,” he joked. “One person thinks they know immediately what needs to be done, and one wants to clarify the problem. But people from all four quadrants are needed for innovation.”

22

The future of IR

March 2020 | Issue 77

2020 vision: What innovations to expect in the IR theatre in the next decade Rahil Kassamali Comment & Analysis Looking ahead to the new decade, Rahil Kassamali highlights the five innovations he believes are most likely to transform the interventional radiology (IR) theatre. Interested in the vanguard, he presented last year at the annual meeting of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE; 7–11 September, Barcelona, Spain) on the future of robotics. Here, he captures the enthusiasm of that meeting, focusing on technologies he feels are worth the hype.

I

f we do an assessment of IR delivery worldwide, we get a mixed picture.

Clinicians in developed countries are striving to develop new minimally invasive procedures and to refine and improve well-established techniques.

However, two thirds of the world’s population do not have access to IR services. Although some developing countries are establishing services, many of these are in their infancy.

The challenges facing healthcare are increasing costs with limited increase in government funding, ageing populations, and more complex pathologies to treat. In contrast, technology is developing at a rapid rate, and we as clinicians need to implement this into our clinical practice.

The last decade has seen exponential growth in numerous disruptive technologies. Some of these have been adopted in healthcare. I predict that in the next decade, the IR community will be leveraging these exponentially growing technologies to improve the delivery of care and training.

This article highlights the five most exciting technologies that you can expect to see in the IR suite this decade.

Smart speaker systems

Smart speakers like the Google Hub and Amazon Alexa are becoming common place in people’s homes. They already have a presence in clinical environments; however, over the next decade, their contribution to patient care will significantly increase.

Being in a sterile environment makes gathering information mid-procedure very challenging. This challenge can

easily be overcome using a smart speaker.

The first dedicated smart speaker application specific to IR was developed

by Kevin Seals [UCLA Health, Los Angeles, USA], and he spoke about this at CIRSE 2019. His application helps proceduralists to choose the correct devices. The app contains information about device dimensions and french sizes so that the interventional

Echo Dot

Rahil Kassamali presents at CIRSE 2019

comorbidities, and medications could be directed towards the smart speaker.

This is a really exciting area and I believe this will be an essential tool to increase efficiency in the interventional theatre within the next decade.

who do not embrace AI will be at a significant disadvantage to their colleagues who strive to utilise AI. I strongly encourage IR departments internationally to collaborate with AI research centres and to find ways to confidentially share patient data to aid the development of these tools.

Artificial intelligence

Artificial intelligence (AI) is a term that is mentioned regularly as the future of all specialties in medicine, and there is a lot of hype around this area. AI is very well-suited to medical imaging.

The main challenge facing AI is the requirement for large datasets. With strict laws around patient data and clinical governance, acquiring these datasets to develop tools has been very challenging.

As AI matures over the next decade, we will be entering the era of truly personalised medicine. There will be specific advantages in interventional oncology. In the next decade, machines will be able to analyse a patient’s demographics combined with their imaging, and will be able to output the

As AI matures over the next decade, we will be entering the era of truly personalised medicine.” radiologist can choose the correct device without having to go to the shelf to look at it.

This could be taken a step further to include information about what is stocked in the cupboards. Rather than staff spending time sifting through numerous balloons and stents, the interventional radiologist could say “Alexa, do we have a balloon that is 3mmx60mm that goes over a 0.018inch wire?”

The most significant step for the development in smart speaker systems will be their integration with electronic patient records. The current challenge surrounds ownership of data and clinical governance—however, I believe a resolution will be found.

When smart speakers are integrated with electronic patient records, the radiology procedure checklist could be led by the speaker, and questions relating to blood tests, allergies,

most appropriate management for this patient. When combined with clinical context, this will significantly aid decision making at multidisciplinary team meetings. In addition, in ablation cases, with the combination of fusion imaging and AI, machines will be able to determine when satisfactory ablation zones have been reached. This will reduce disease recurrence and overall will improve the delivery of care to our patients. As datasets improve, the analysis of tumours will significantly advance, giving much more detail than can be determined by the human eye.

There are already AI tools related to angiography which can accurately identify stenoses and occlusions and can suggest the correct size devices to treat these lesions.

Since the advent of AI, there have been articles stating that the radiologist will be extinct. I believe the radiologists

Robotics

The field of robotics is something that has been around for over a decade in IR, though it has faced significant challenges. In 2008, the Magellan Robot from Hansen Medical was released. This had the benefits of steerable catheters and wires, and a control unit remote to the IR theatre. The system offered significant advantages in patients with complex vascular anatomy, with the added benefit of reduced radiation to the operator. Studies have shown that this robotic system improved vessel cannulation times and reduced vascular wall trauma due to reduced arterial wall hits compared to conventional cannulation. The Magellan robot went through several rounds of evolution, and even had a 3F steerable catheter, however Hansen Medical was taken over and further development of this robot ceased.

Another system—called Corepath, owned by Siemens—has taken the concept of being remote to the room but lacks the advantage of a steerable catheter. Their main focus has been cardiovascular angiography; however, they are moving into the IR space.

The system that I am really excited about disrupting the IR robotics space in the next decade is being developed and researched at Imperial College, London, UK. The team at Imperial are part of a well-funded robotics project and are taking the learning points from Magellan and Corepath to develop a new robotic system with the added advantage of being MRI compatible, with catheters and wires that are visible under MRI guidance. Preliminary models and animal studies have been very positive.

Going into the next decade, interventional radiologists will be asked to do more and more procedures on very complex anatomy. The use of robotics in major centres will help this subset of

The future of IR

Issue 77 | March 2020 patients and will reduce complications.

My personal dream is to see robotic hubs in areas of the world where access to IR is limited, so that patients can benefit from well-trained interventional radiologists anywhere in the world, a concept I call “tele-interventional radiology”.

Augmented reality

Traditional training has been the apprenticeship model, with doctors with relatively limited experience starting to do procedures on patients.

As a patient, however, I would prefer to know that all trainees have had significant exposure before attempting to do a procedure. Over the last decade, there has been an explosion in video learning, and these videos have become increasingly sophisticated. Now using 360 degree cameras to film scenarios and playing these within virtual reality headsets, trainees can gain the experience of being inside a theatre and observing a procedure multiple times prior to becoming the hands on apprentice.

Taking augmented reality a step further, into clinical practice, when performing procedures, an accurate depiction of a patient’s internal anatomy can be projected onto the skin. This can assist with access and needle guidance. This would make the already available guide tools much easier to use.

Augmented reality 3D vascular guide tools using fusion imaging are also becoming available for embolization techniques.

Over the next ten years, augmented reality will revolutionise procedural training. In addition, it will become a normal part of an IR suite’s software.

Its introduction into clinical practice will improve the accuracy of needle, catheter, and wire guidance.

3D printing

The evolution of 3D printing over the last decade has been exponential.

Technology is now advanced enough to produce models of very complex biliary or vascular anatomy at a very low cost to help plan, practice, and teach procedures. A study published in the Journal of Vascular and Interventional Radiology (JVIR) demonstrated that 3D models can be created at prices below US$50 per model. The ability to plan a complex intervention with accurate measurements and a clear understanding of the 3D anatomy will increase the success rate of complex procedures.

I believe that in the next decade, every radiology department will have the computer-aided radiology software required for 3D printing, and will have a low-cost 3D printer within the department.

In aortic intervention, patient-tailored stents are already used. I expect that this will become more common in other areas of IR as industrial 3D printing further develops into the production of stents.

Very soon many of the devices will be specifically tailored to the patient we are treating to give the best results.

Conclusion

With so many exciting innovations on the horizon, my main message is to become an earlier adopter of technology.

When selecting equipment for your hospital choose the most advanced software options and start to utilise these to improve patient care. If you have ideas about innovations, discuss these with industry to bring them to market.

The landscape of healthcare is changing and your expression towards innovation will demonstrate your commitment to continue improving patient care.

Rahil Kassamali is a consultant interventional radiologist at the University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.

Oculus Rift in the operating room

23

24

Conference news

March 2020 | Issue 77

Novel radiopaque microspheres in Y-90 radioembolization show potential to map absorbed radiation dose in a porcine model A proof-of-concept study has demonstrated the feasibility of using computed tomography (CT) with a novel composition of radiopaque microspheres in Yttrium-90 (Y-90) radioembolization to determine tumour radiation dose exposure. Presenting these early results at Spectrum (18–21 January, Miami, USA), Robert Abraham (Dalhousie University QEII Health Sciences, Halifax, Canada), told delegates that this technique “may provide increased confidence in the true spatial distribution of the microspheres, and hence the distribution of Y-90 activity in tumour”.

OUTLINING HIS HOPES for Y-90 based CT radiopacity, Abraham said he thinks it “may improve characterisation of the absorbed dose heterogeneity in radioembolization”, and “may improve our understanding of the relationship between absorbed dose and tumour response, which could ultimately translate into improved patient outcomes”.

Using a proprietary blend of non-irradiated radiopaque Y-90 glass microspheres (30µm in diameter), Abraham described how the investigators injected 480mg through a 0.021” Cook Cantata microcatheter into the segmental arteries in the left kidney of a hybrid farm pig.

Following sacrifice, the kidney was explanted and imaged by conventional CT scan. Three-dimensional convolution of the activity distribution with a validated Y-90 dose point kernel was implemented to produce a high-resolution dose distribution.

“The dose distribution images in the axial plane using MATLAB software simulates the effect of

increasing microsphere deposition,” Abraham stated, showing the Spectrum audience five axial CT images of the left kidney with increasing amounts of deposited microspheres. “As you can see, from left to right, as you increase the quantity of microspheres that are deposited in the tissue, the radiopacity increases accordingly”, he shared. Indeed, there is a linear relationship between CT Hounsfield Units (HU) and microsphere concentration per CT voxel, according to previously published work

by ABK Biomedical.

Explaining the implications of this relationship between increased deposition and increased radiopacity, he continued: “Using the specific activity at the time of administration, we could potentially convert radiopacity threshold maps to dose threshold maps.” As increased deposition of microspheres correlates with an increased dose, Abraham described how it is possible to build a colour map depicting specific thresholds. “For example, here we used a threshold of 210Gy which some studies have suggested is a minimum target threshold in order to

Robert Abraham

obtain tumour kill with glass Y-90. Based on radiopacity mapping and conversion to dose we may be able to confirm a minimum of 210Gy in the target tissue” he said, again showing a CT scan of the left kidney coloured according to dose.

Turning to future work, Abraham said: “We are doing ongoing studies on different compositions that have been developed. We will evaluate the potential of CT dosimetry with both cone beam CT, to allow intraprocedural dosimetry, as well as post-procedural conventional CT. We will also be commencing a hypervascular tumour model trial with activated Y-90 product. This will compare CT radiopacity-based dosimetry with time of flight PET [positron emission tomography] dosimetry.”

Abraham is a co-founder and shareholder of ABK Biomedical, co-inventor of ABK’s proprietary investigational products, and serves as ABK’s Chief Medical Officer.

Pre-clinical results suggest novel ablation modality may stimulate an abscopal immune response in liver cancer patients

Investigators report a 100% technical success rate in creating their planned ablation volume and no major device-related complications in the first-in-human clinical cases using histotripsy, a novel ablation modality. Presented at Spectrum (18–21 January, Miami, USA) by Emily Knott, a research intern at the Department of Radiology, University of Wisconsin, Madison, USA, and currently applying to medical school, these early positive results offer “real potential” for the future of this therapy.

H

istotripsy is a non-invasive, non-thermal ablation modality that uses focused ultrasound to create a cavitation bubble cloud which destroys the target tissue. This cavitation bubble cloud is precise at the histologic level: the resultant ablation zones are within millimetres of the prescribed location. “Coupled with a robotic arm, you can virtually prescribe any size and shape of ablation zone,” Knott described.

The tissue within the ablation zone is completely necrotic.

“An interesting characteristic,” Knott observed, “is that because of these mechanical tissue destruction effects, there is architecture preservation within the ablation zone, including bile ducts

and large vessels.

“The most interesting part of this technology, though,” she continued, “is the potential for an immune response.”

Sharing early histotripsy studies conducted in mice at the University of Michigan, she described how investigators witnessed an abscopal response that is greater than radiation therapy and thermal ablation, as well as finding decreased metastases in the pulmonary area.

Describing the first ever human clinical cases, Knott told the Spectrum audience of the 100% technical success rate in creating the planned ablation volume, and of the lack of device-related complications.

Emily Knott

The most interesting part [...] is the potential for an immune response.”

Two patients demonstrated a potential abscopal response to therapy. Showing the MRI scans of one of these patients on her slides, Knott said: “The really exciting thing with this patient is that when we treated one tumour, a small percentage of this patient’s disease, the AFP [alpha-fetoprotein, a tumour marker] dropped disproportionately over eight weeks.”

In a second patient, with metastatic colorectal cancer, Knott recounts how the team treated a single tumour in the left

lobe of the liver. One day post-treatment, imaging showed the tumour swelling slightly “with some inflammation”, but over time, it decreased in size to smaller than before ablation. “CEA [carcinoembryonic antigen, used as a diagnostic and prognostic tumour marker] also dropped disproportionately to the one tumour that we treated in the liver,” Knott said.

She concluded: “Histotripsy is a non-thermal and non-invasive ablation modality. It can safely create a planned ablation volume, and there is a potential immune stimulation in early pre-clinical results in mouse models, and in two of eight patients in an early clinical trial.

This clinical trial will be more finalised and [eventually] published.” These results were presented at the annual meeting of the Society of Interventional Oncology (SIO; 31 January–3 February, New Orleans, USA).

Locoregional cancer treatments

Issue 77 | March 2020

SBRT offers good disease control out to five years in men with locally recurrent prostate cancer Stereotactic body radiation therapy (SBRT) in previously irradiated patients “appears clinically feasible”, and provides good disease control out to five years for men with locally recurrent prostate cancer. This is the conclusion of a recent prospective study from Donald Fuller (Genesis Health Care Partners, San Diego, USA), published in the International Journal of Radiation Oncology Biology Physics.

THE INVESTIGATORS SET out to evaluate the use of SBRT retreatment for biopsy-proven local persistence in prostate postradiation therapy, evaluating efficacy and toxicity. For this patient cohort, the authors explain how a number of local salvage methods have been described, but say that none have been widely used, “primarily owing to elevated toxicity concerns”.

Analysing outcomes in the 50 patients enrolled in the study from February 2009 to March 2018 from two community-based radiation oncology centres, Fuller et al assessed toxicities before and after SBRT salvage using CTCAE v.3 criteria and International Prostate

Symptom Score (I-IPSS). SBRT was performed with the CyberKnife system from Accuray.

The authors report that 69% of the patients required no androgen deprivation therapy (ADT) treatment within the first five years following CyberKnife prostate SBRT. There were also low overall rates of toxicity among the patients, all of whom had undergone radiation therapy treatment prior to SBRT. “Most men, if treated, receive only ADT, which has the potential for long-lasting whole-body side effects while rarely eradicating the tumour completely,” Fuller comments. “Without effective local retreatment, it is likely that most, if not all of them [the patients treated in this study], would have needed ADT treatment at a far earlier point in their history. Because ADT has many long-lasting detrimental ‘whole body’ symptoms, effective SBRT local salvage thus preserves better quality of life, greatly delaying or avoiding ADT systemic effects for most patients.”

Furthermore, at five years, the disease-free survival rate was 60%, indicating patients experienced no signs or symptoms of their cancer during that time.

The authors write: “In spite of the relatively highrisk patient population described herein, the five-year biochemical relapse-free survival rate of 60% confirms extended disease-free survival in the majority of SBRT salvage cases.”

Comparing SBRT favourably to radical prostatectomy, Fuller and colleagues say: “We also report a biochemical relapse-free efficacy rate that appears at least comparable to that reported with salvage radical prostatectomy; 60% five-year biochemical relapse-free survival in the present series versus 57% three-year biochemical relapsefree survival in a contemporary salvage radical prostatectomy series of similar size and similar median follow-up. This suggests a definite role for salvage SBRT, particularly well-suited for those who either do

25

not desire to or are not physically able to withstand the rigours and potential complications of a salvage radical prostatectomy procedure.”

The median prostate-specific antigen decreased to 0.16ng/mL at five years, similar to initial treatment with brachytherapy and lower than typical conventional fractionation, based on results from other studies.

No grade two or higher gastrointestinal events were reported. Genitourinary toxicity also was lower than reported rates for salvage radical prostatectomy and seems less frequent after prior standard external radiation treatment.

“Our results suggest that efficacious salvage of locally recurrent prostate cancer with SBRT is possible, with an acceptable toxicity risk, in appropriately selected patients,” Fuller et al conclude.

Because ADT [androgen deprivation therapy] has many longlasting detrimental ‘whole body’ symptoms, effective stereotactic body radiation therapy [SBRT] local salvage thus preserves better quality of life, greatly delaying or avoiding ADT systemic effects for most patients.”

28

Section Name

March 2020 | Issue 77

80% of BSIR members vote for IR to gain specialty status in the UK Members of the British Society of Interventional Radiology (BSIR) have voted overwhelmingly in favour of interventional radiology (IR) becoming a specialty in the UK. Of 350 votes cast, 80% (279) were in favour, and 20% (71) were against.

BSIR MEMBERS HAD 24 hours to vote on the motion “Should interventional radiology become a specialty?” during the society’s 2019 annual scientific meeting (13–15 November, Manchester, UK). The society’s annual general meeting (AGM) took place during this voting window, and allowed participants to discuss the ramifications of voting for or against granting IR specialty status.

Whether or not IR will become a specialty is still under the auspices of the Royal College of Radiologists (RCR), explained BSIR vice president Philip Haslam (Freeman Hospital, Newcastle-Upon-Tyne, UK), but he said that the results of this vote “give us [BSIR] a mandate now, from our members, to take this forward with the college of radiologists, with the General Medical Council (GMC), and hopefully achieve our aims”.

IR became a specialty in the USA in 2014 and, by 2018, was the most sought after specialty amongst medical students. While the healthcare system differs between the USA and UK, proponents of IR becoming a specialty in the UK argued that “there is much to learn” from this US success. The Royal Australian and New Zealand College of Radiologists (RANZCR) have recently published a white paper looking to develop an IR specialty in Australasia. In continental Europe, the German Society of Interventional Radiology and Minimally Invasive Treatment (DeGIR) have their own exam, which implements a modular system for training.

France and The Netherlands are currently exploring options for IR to become a specialty.

What happens next?

“This is the start of a long and slightly painful process,” Raman Uberoi (Oxford University Hospitals NHS Foundation Trust, Oxford, UK) told BSIR delegates, “because it is tricky to become a specialty”.

BSIR will begin talks with the RCR and then jointly with national training bodies including the GMC, clinical oversight group (COG) and the UK Medical Education Reference Group (UKMERG), to make the case for IR becoming a specialty. This decision will ultimately come from the Privy Council, but Uberoi emphasised that “the message needs to come from the bodies to say that it is vitally important that IR becomes a specialty”.

The Privy Council is a formal body of advisers to the Sovereign of the UK, and is responsible for some of the affairs of the GMC. Following an initial, positive reaction from the GMC, Uberoi reported that the Privy Council were not supportive of IR becoming a specialty (“Their knee-jerk response is ‘no’ to any new specialty,” he said).

However, he added that the case had never been made directly to the Privy Council, and that BSIR needed to work with the RCR and GMC “to make the arguments cogent” before making the final submission to the body.

This process may take “many years”, he said.

Specifically addressing the BSIR members, he urged: “A lot of us will need to go into the college, a lot of us will need to be involved in the creation of the specialty and actually delivering for the future.

“Ultimately, this is about quality and patient safety, and improving outcomes,” he continued. “That means, we have to have better training, we need better access to clinics, and to occupy those clinics, and then to get better workforce planning for the future. But this needs

buy in from all interventional radiologists, because this is not something that Council or a small group of people can take forward. We all need to push for this and we all need to believe in this project, because it will take some time. It will not impact on any consultants working today.

This is the future; this is next generation of interventional radiologists that we are looking to. So we are looking at something that is going to take eight or nine years before we see the full benefits. We need to be doing other things besides in the interim, but I think this is vital for the future survival of IR, and more importantly, it is going to give us high-quality, focused care.”

Graham Plant Lecture advocates for IR to become a specialty

In his Graham Plant Lecture at the annual meeting, Uberoi took the opportunity ahead of the vote to make the case in favour of IR gaining specialty status. “We have become integral to the management of not all, but a large number of patients in virtually every specialty in the hospital setting,” he said. “We play a key role in their

doing for the last 20 years, but I can tell you that, yes, it has given us some benefit, but I do not think that we can do much more.” Listing what he saw as the potential benefits, he enumerated: Improved provision of 24/7 IR services, quality of IR training and patient safety throughout the UK Improved IR workforce planning by matching training to need More defined career path for IR Widen the pool of doctors considering a career in IR Strengthen the voice of the RCR nationally by creating a three-specialty college—therapeutics and diagnostics Uberoi mentioned concerns his IR colleagues had raised with him about becoming a specialty, which he hoped to alleviate in his Graham Plant Lecture. Firstly, he said, some people worried that becoming a specialty may adversely impact the number of doctors joining IR. Addressing this, he said: “I think we are in a poor place [with recruitment]; I think we can only get better.”

Furthermore, he said there is “a lot of confusion” about what happens with diagnostic radiologists who currently do IR. “This does not stop anybody from doing IR. On the contrary, it is give greater guidance and support for their practice in their roles from the specialty, which will ensure the quality standards that we need to adhere to,” he explained. “Similarly, those who do diagnostic radiology (DR) and IR will be able to continue doing so. DR is key to what we do, it is what distinguishes us from other surgeons. We need imaging, and we can and should continue to do DR, as long as we adhere to the RCR quality standards and look to our patient’s needs.

We will continue to be trained in and do imaging.”

This concern was discussed further by BSIR members after the Graham Plant Lecture, before voting closed.

In particular, congress attendees asked about the RCR’s attitude towards IR becoming its own specialty, with one

Voting results

For

80%

treatment in nearly every sense that I can think of.”

However, he continued: “I think there is a problem.

This issue that Charles Dotter [founder of interventional radiology] himself identified, and others after him identified, is the role of clinician versus technician. It is really about who is clinically responsible for the patient?

Who is clinically responsible for the patient has huge connotations: the hospital management team, NHS England, the Trust, really focus on those individuals, supporting them with infrastructure and resources. They are seen as the primary clinician managing that patient.

I argue that many of us are still behaving very much as technicians; the responsibility lies with surgeons or physicians. They are seen as the specialist clinician and, not unreasonably, a lot of organisations will focus their attention and their resources on those areas.”

Speaking in advance of the BSIR membership vote on the matter, Uberoi said, “I think it is vitally important that we consider becoming a specialty. I am not one for doing things just for the sake of it; I really believe this is crucial for our future development and survival. We can carry on sculling, keep doing the same things that we have been

20% Against

audience member flagging that the college may view this as taking numbers away from DR. “I do not think they are overjoyed,” Uberoi conceded, “because I think this is an unnecessary, from their perspective, headache, and it is a real problem for them.” However, he went on to counter: “Yes, we will be taking numbers from DR initially, but of course these would reflect for trainees who are currently going into IR. Over time, I think we will increase IR numbers not at the expense of DR.” Uberoi described the RCR’s stance towards designating IR specialty status as “lukewarm”, in his opinion. “I think we can only do this with full college support,” he said. I think we need to make people understand why we want to do this: it is not a backlash against DR, it is about our future, the future survival of our specialty.”

Following dialogue with RCR, BSIR president Ian McCafferty (Queen Elizabeth Hospital Birmingham, Birmingham, UK) was positive about the college’s response: “They [the RCR] also understand that we cannot stay where we are. They know we have to evolve in some shape, way, or form.”

Market watch

Issue 77 | March 2020

Clinical News PATHFINDER I registry launches to evaluate performance and clinical outcomes of the AURYON atherectomy system

AngioDynamics has launched PATHFINDER I: Post-Market Registry (PATHFINDER I-Registry, EXPAD-05), a pilot study to evaluate the safety and efficacy of the company’s AURYON atherectomy system in the treatment of de novo, restenotic, and in-stent restenosis (ISR) lesions in infrainguinal arteries of patients with peripheral arterial diseases (PAD).

The AURYON atherectomy system, previously known as the Eximo B-Laser, is a proprietary 355nm wavelength lasertechnology platform that was acquired

by AngioDynamics in October 2019.

AngioDynamics’ PATHFINDER I registry is a prospective, nonrandomised, single-arm, multicentre observational study that will evaluate the performance of the AURYON atherectomy system during procedures and measure clinical outcomes, both intermediate and long-term. A total of 100 eligible PAD patients treated with the AURYON atherectomy system in a post-market setting will be enrolled and tracked for a 36-month period after the initial procedure. Initial findings from the pilot registry study will contribute to a subsequent large pivotal phase registry that is expected to include approximately 1,000 patients.

US commercial release will occur in the second half of the fiscal year.

LUMBRA, real-world study of luminor DCB in Brazil, commences

A real-world study investigating the luminor drug-coated balloon (DCB; iVascular) in Brazil has started, following approval for commercialisation of the device by ANVISA, the Brazilian regulatory authority. LUMBRA (luminor balloon in a Brazilian registry for real-world lesions) aims to corroborate the efficacy and safety results of luminor in Europe demonstrated by the EFFPAC and TINTIN trials.

The trial has the objective of evaluating the long-term outcomes

Luminor DCB

of treatment with the luminor DCB, followed by potential bail-out stenting with the iVolution stent (iVascular) in symptomatic femoropopliteal arterial stenotic or occlusive lesions in 200 patients from Brazil. The first patient to be enrolled was included on 30 November 2019.

The primary endpoint of the registry is primary patency at 12 months. The secondary endpoints include: technical success, procedural success, primary patency rate, freedom from target lesion revascularisation, changes in anklebrachial index measurements, and serious adverse events, as defined per ISO 14155:2011.

Patient enrolment completed in MedAlliance PRESTIGE below-the-knee clinical trial

Patient enrolment in the PRESTIGE below-the-knee (BTK) clinical trial has been completed. The objective of this investigation is to evaluate the sixmonth safety and performance outcomes of SELUTION SLR, MedAlliance’s novel sirolimus-eluting balloon, for the treatment of long tibial occlusive lesions (TASC C and D) in patients with critical limb ischaemia (CLI).

PRESTIGE is a prospective, singlecentre, physician-initiated clinical study, being run at Singapore General Hospital, Singapore, by Chong Tze Tec and Tang Tjun Yip. Twenty-two patients have now been enrolled. Clinical follow-up will be at one, three, six and 12 months.

“The initial performance of SELUTION SLR has been very encouraging”, Tec says. “We have observed good blood flow in the amputation segment and some cases of fast wound healing. The device is also easy to track and deliver. We are eagerly awaiting the study’s follow-up data”.

Singapore has a high percentage of diabetics in its population, and CLI therefore constitutes a major challenge among patients seen with peripheral arterial disease (PAD). Singapore General Hospital (SGH) performs over 1,000 interventional procedures a year on patients suffering from CLI. The PRESTIGE study, utilising a sirolimus-eluting balloon, is particularly significant in the wake of current controversy surrounding paclitaxelcoated balloons (see page 14), a MedAlliance press release states.

Historically, paclitaxel has been the drug of choice for use in drug-coated balloons (DCBs). SELUTION SLR is the first sirolimus drug-eluting balloon specifically designed to treat PAD. This device combines the safety and efficacy of sirolimus with advanced MicroReservoir and cell adherent technology to offer a sustained therapeutic effect for over 60 days, achieving long-term clinical benefits.

The MicroReservoir combines sirolimus with a biodegradable polymer.

Millions of these MicroReservoirs act as miniature drug-delivery systems, achieving sustained sirolimus release.

The cell adherent technology achieves drug bioavailability and minimal systemic loss, allowing for a lower drug dose concentration on the balloon surface (1μg/mm²). Proprietary amphipathic lipid technology binds microreservoirs to the balloon surface to protect during insertion and navigation of the balloon. Once the balloon is inflated, the cell adherent technology ensures transfer of microreservoirs to the tissue and cellular uptake of the sirolimus drug.

MedAlliance was granted breakthrough designation by the US Food and Drug Administration (FDA) on 20 September 2019.

Positive two-year data from the first-in-human study of SELUTION SLR was presented at the 2019 Vascular Interventional Advances conference (VIVA; 4–7 November, Las Vegas, USA) by principal investigator Thomas Zeller (Universitaets-Herzzentrum, Bad Krozingen, Germany). The study involved 50 patients treated with the investigational device in lesions of the superficial femoropopliteal arteries.

Philips announces WETRUST multicentre clinical trial to assess impact of direct-to-angiosuite workflow on stroke patient outcomes

Philips has announced a major clinical trial to assess the impact of a directto-angiosuite workflow on stroke patient outcomes. The study will assess whether with Philips’ advanced imageguided therapy platform it is possible to diagnose, plan, and treat stroke patients in the interventional suite without requiring an initial CT or MRI exam. The multicentre, prospective, randomised, controlled, open-label, blinded-endpoint trial will be run across eight sites and involve over 460 patients globally. It will begin in the first half of next year and is expected to be completed in 2022.

Outcomes for stroke patients are closely tied to how quickly they receive treatment: every 30 minutes’ delay before treatment reduces the chance of a good outcome by 14%, and every hour of delay ages the brain by 3.6 years compared to a normally aging brain.

Currently, when a possible stroke patient arrives at the emergency department, they typically first undergo a CT or MRI exam and, in the case of an ischaemic stroke, are then treated in an interventional suite. Several studies have indicated that a direct-to-angiosuite workflow can reduce the time to treatment and improve patient outcomes.

Philips is developing new technology to further improve the CT-like images of the brain created with the X-ray system in the suite. The WE-TRUST (Workflow optimisation to reduce time to endovascular reperfusion in stroke treatment) trial will provide the most comprehensive assessment to date of the impact of this technology and workflow innovation on time-to-treatment and

31

patients’ neurological outcomes.

“Significant advances in technology mean that we are now able to identify, plan, and treat ischaemic stroke patients in the angiography suite, without the need for a separate CT or MR scan” says Raul G Nogueira, director, Neuroendovascular Service Marcus Stroke & Neuroscience Center at Grady Memorial Hospital in Atlanta, USA, and principal investigator for the WE-TRUST trial.

The trial will primarily be carried out on Philips’ Azurion, the company’s platform for interventional procedures, at eight leading stroke sites in Europe and the USA. The primary endpoint of the WE-TRUST trial is patients’ cognitive function at three months after the procedure.

Azurion

QuiremScout shows superior predictive value to technetium-99mmacroaggregated albumin during SIRT work up

A recent study comparing holmium-166 (QuieremSpheres, from Terumo) to technetium-99m-macroaggregated albumin (99mTc-MAA) as a work up for selective internal radiation therapy (SIRT) has found QuieremSpheres to be superior in terms of predicting which patients with liver cancer will benefit from SIRT treatment. The results were published in the European Journal of Nuclear Medicine Molecular Imaging.

The aim of the study was to analyse whether the intrahepatic distribution of QuiremScout has a better agreement with the QuiremSpheres distribution when compared with 99mTc-MAA. Several scientific papers have indicated that the widely used 99mTc-MAA has limited predictive value.

The present study included 53 patients that had been included in either phase 1 or phase 2 Holmium embolization particles for arterial radiotherapy (HEPAR) studies, and showed QuiremScout has superior predictive value for intrahepatic distribution in comparison to 99mTc-MAA. “Previous studies already demonstrated that QuiremScout is safe in this population, and, moreover, a better predictor for lung shunting than 99mTcMAA,” first author Maarten Smits comments. “As a result, QuiremScout allows for more accurate SIRT patient selection. Now, our study shows the potential of QuiremScout to also improve the efficacy of SIRT, by allowing a more accurate and truly personalised pretreatment activity planning.”

QuiremScout is the first SIRT work up product that utilises the same technology as the therapeutic microspheres, which aims to optimise patient selection and advance treatment planning when compared to using 99mTc-MAA.

Market watch

Issue 77 | March 2020 balloon movement and ensures paclitaxel is released in the target lesion without particle loss in the blood flow.

Product News Alucent Biomedical announces FDA approval to proceed with natural vascular scaffolding clinical trial

Alucent Biomedical has received US Food and Drug Administration (FDA) approval to proceed with a phase 1 clinical trial to evaluate the safety and efficacy of its Natural Vascular Scaffolding (NVS) technology. The therapy is designed to treat peripheral arterial disease (PAD) of the lower extremities, a condition that affects over 200 million people worldwide.

According to a press release, the Alucent NVS vessel restoration system with photoactivated linking combines standard angioplasty with linking of the structural proteins in the wall of a blood vessel. The intervention is designed to deliver immediate restoration of the vessel’s lumen and sustained improvement of blood flow, without the introduction of a foreign implant, such as a metallic stent, into the patient’s body. Because there is no rigid foreign material, the arterial wall has the potential to retain its natural functionality and flexibility, and avoid the complications of permanent stents.

Alucent NVS photoactivated linking is also designed to mitigate the adverse effects of angioplasty, such as vessel recoil. Sustained, improved blood flow is expected to result in pain relief, limb preservation, and an improved quality of life for patients.

“FDA approval to commence human clinical testing allows us to move this revolutionary therapy into PAD patients, many of whom are in acute need of a better and more durable alternative to currently available treatments,” comments Myles Greenberg, Alucent CEO. Preclinical testing of NVS in animal studies has shown acute and long-term safety and patency without the proinflammatory and mechanical risks of placing a rigid foreign implant into the blood vessel.

“Alucent NVS is a novel and disruptive medical therapy that may promote better clinical outcomes in patients with symptomatic femoropopliteal atherosclerosis without the use of a metallic implant. Moreover, given the novel nature of this therapy, which in animal models was able to restore vessel wall architecture, it has the potential to dramatically improve quality of life in patients with peripheral arterial disease”, says Krishna RochaSingh, chief scientific officer at HSHS St John’s Prairie Heart Institute in Springfield, USA, and chief medical advisor of Alucent Biomedical.

Enrolment for the phase 1 clinical trial began in Q1 2020. Up to 15 patients will be enrolled across five research sites, including the Cardiovascular Institute of the South in Houma, USA, and the

Wellmont Hollston Valley Medical Center in Kingsport, USA.

Cook Medical launches TriForce peripheral crossing set

The TriForce peripheral crossing set, from Cook Medical, is now commercially available in the USA. As of January 2020, these products are available to physicians in the USA to support procedures to treat patients with vascular obstructions.

According to the company, the TriForce peripheral crossing set is designed to be percutaneously introduced into blood vessels and support a guidewire while performing a peripheral intervention. The device is also intended for injection of radiopaque contrast media for angiography.

Luminor DCB now reimbursed in France

Luminor 18 and Luminor 35 drugcoated balloons (DCB; iVascular) are now listed on the French LPPR (list of products and services approved for reimbursement) for de novo lesions of the femoropopliteal arteries.

Luminor is a paclitaxel-coated balloon specifically designed for dilatation of stenosis located in the iliac, femoral, iliofemoral, popliteal, infrapopliteal and renal arteries, as well as for the treatment of obstructive lesions of arteriovenous fistulaes, whether original or artificial.

Eric Ducasse (CHU Bordeaux, Vascular Surgery Unit, Bordeaux, France) has been one of the first Luminor users in France. He comments: “Luminor is the first paclitaxel DCB reimbursed in France since the Katsanos et al publication. It underlines that French authorities do trust its last generation coating technology, which is unique and has demonstrated efficacy, and, above all, safety. I am confident that French use and data analysis will confirm it shortly.”

The latest EFFPAC trial two-year outcomes with Luminor have shown positive results in terms of primary patency (90.2%) and freedom from target lesion revascularisation (97.2%) in the superficial femoral artery and popliteal artery for TASC A and B lesions. The trial also demonstrated no increased risk of death detected at two years (one death in the DCB group versus two deaths in the percutaneous transluminal angioplasty group), evidencing a relative risk of 0.48.

The Luminor DCB has a proprietary nanotechnology coating, TransferTech.

This uses paclitaxel in a microcrystalline molecular structure that is spread on the balloon, together with the excipient, by ultrasound spray pulse. The balloon surface is covered with multiple and independent nanodrop layers, providing a flexible coating that adapts to the

Merit Medical receives FDA breakthrough device designation for Wrapsody endovascular stent graft system

Merit Medical Systems has announced that it has been granted breakthrough device designation by the US Food and Drug Administration (FDA) for the Merit Wrapsody endovascular stent graft system. The Wrapsody system is a flexible, self-expanding endoprosthesis for which Merit intends to seek indication for use in haemodialysis patients for the treatment of stenosis within the central veins of the outflow Wrapsody

circuit of an arteriovenous fistula (AVF) up to the superior vena cava.

The FDA breakthrough devices programme is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for lifethreatening or irreversibly debilitating diseases or conditions. Under the programme, the FDA provides priority review and interactive communication regarding device development and clinical trial protocols, through to commercialisation decisions. The Wrapsody system is nearing completion of its first-in-human studies, and is not currently available for sale.

Merit Medical launches Resolve mini locking drainage catheter

Merit Medical has announced the commercial launch of the Resolve mini locking drainage catheter, the most recent addition to the company’s line of innovative Resolve locking drainage catheters. The Resolve mini is intended for the percutaneous drainage of fluid from body cavities, and its mini pigtail design—which is up to 42% smaller than the standard Resolve locking drainage catheter pigtail—allows the catheter to be placed into small fluid pockets.

The Resolve mini features a tapered tip and hydrophilic coating for smooth introduction, designed to reduce patient discomfort, a Merit Medical press release reports. Depth markers located on the catheter shaft aid accurate placement and act as a reference for correct positioning, and a radiopaque marker band denotes where the pigtail is to ensure all the holes are in the fluid pocket. The device features multiple large holes to help maximise drainage.

Additionally, the Resolve mini includes a secure locking mechanism that makes it difficult for patients to unlock

33

the catheter, a pigtail straightener to help insert the cannulas into the catheter easier, and a catheter tip positioned within the pigtail curve, designed to reduce tissue irritation. Flexible polyurethane material prevents kinking and ensures catheter rebound, and an included repositioning tool helps unlock and reposition the catheter at any time.

Omega Medical Imaging first in the world to receive FDA clearance on artificial intelligence imaging system that reduces dose

Omega Medical Imaging, manufacturers of Artificial Intelligence Fluoroscopy/ Cine (AIF/C) Imaging systems, have announced US Food and Drug Administration (FDA) 510(k) clearance of FluoroShield with their 2020 cardiac flat panel detector.

The FluoroShield system allows for auto-collimation during interventional fluoroscopy or cine cases, while maintaining a perspective of the surrounding anatomy. The blended image incorporates a lower frequency refresh of the peripheral image area, a press release explains. This combined image (live fluoroscopy or cine and background refreshed at a rate of once or twice per second) increases the quality of information presented during interventional procedures.

FluoroShield system

Brian Fleming, president of Omega Medical Imaging, states, “Until now, products on the market have only been able to manage radiation to patients and staff. FluoroShield is the only system in the world that provides an actual reduction in dose.”

New TriNav infusion system launches to overcome infusion barriers within solid tumours

TriSalus Life Sciences has launched its TriNav infusion system. Powered by its proprietary pressure-enabled drug delivery (PEDD) approach with SmartValve technology, TriNav is designed to help overcome the infusion barriers that limit therapeutic uptake in solid tumours, including hepatocellular carcinoma (HCC) and liver metastases.

TriNav can provide interventional radiologists intravascular tumour access with improved trackability, compatibility with standard angiographic catheters, and workflow comparable to standard interventions. The tumour microenvironment creates pressure barriers that limit flow into solid tumours.

PEDD with SmartValve creates a highpressure gradient that improves delivery and penetration of therapy into tumours.

The porous expandable SmartValve is

34

Market watch

March 2020 | Issue 77

Product News designed to allow antegrade flow, and leverages blood flow to carry the dose deep into the solid tumour. SmartValve enables therapy delivery to the intended target while minimising non-target delivery that has been shown to damage healthy tissue.

In a clinical study, PEDD with SmartValve demonstrated the ability to overcome tumour infusion barriers and significantly improve response rates in HCC. Outcomes from a retrospective, single-centre study of patients with solitary HCC tumours who underwent treatment utilising either PEDD or standard end-hole microcatheters, showed 100% objective response with PEDD versus 76.5% with standard end-hole microcatheters (p=0.019).

Additionally, after first treatment, pathological response as shown by tumour necrosis percentage was

significantly greater with PEDD (88.8%) versus standard end-hole microcatheters (33.8%; p=0.026). Improving response rates could potentially help more patients meet transplant criteria, lead to successful down-staging, bridging, and post-transplant survival.

The Centers for Medicare and Medicaid Services (CMS) granted TriNav transitional pass-through payment as part of the 2020 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System (CMS-1717-FC), effective 1 January 2020.

First-of-its-kind XACT robotic system cleared

by FDA for percutaneous interventional procedures

XACT Robotics has received clearance from the US Food and Drug

Administration (FDA) to sell its first robotic system in the USA for use during CT-guided percutaneous interventional procedures. XACT’s technology is the first hands-free robotic system combining image-based planning and navigation with insertion and steering of various instruments to a desired target across an array of clinical applications and indications.

“We are committed to redefining the way the entire medical community utilises robotics, beginning with interventional radiologists,” says Harel Gadot, founder, executive chair, and president of XACT Robotics. “Being the first to introduce a hands-free robotic system, we have the potential to provide significant clinical, technical, and economic value while democratising interventional procedures. Our system’s small footprint and high mobility design will enable care providers to treat a broad range of patient care needs in various clinical sites of service.”

“The XACT Robotic system provides a unique platform to the interventional radiology community which can help

improve the delivery and quality of care for the patients we serve,” comments Nahum S Goldberg, the principal investigator in a multisite study using the system, which is still an investigational device in Israel, where XACT Robotics is based. Goldberg is the head of the Interventional Oncology Unit and director of the Applied Radiology Research Lab at Hadassah Hebrew University Medical Center, Jerusalem, Israel. “Based on our experience with this unique robotic technology, we can reach very small targets with unprecedented accuracy. Furthermore, this system holds much promise for enabling more efficient use of time and hospital resources.”

The XACT Robotic system is based on research originally conducted at the Technion—Israel Institute of Technology,

by Moshe Shoham, founder of Mazor Robotics (acquired by Medtronic in 2018). The company plans to launch the system to select US radiology centres of excellence partners, and debuted its technology at the 2019 Radiological Society of North America conference (RSNA; 1–6 December, Chicago, USA).

Calendar of events 21–24 April Charing Cross (CX) Symposium London, UK www.cxsymposium.com

22–23 April Interventional radiology: The basics course Plymouth, UK www.penra.org.uk

14–17 May Global Embolization Cancer Symposium Technologies (GEST) US New York, USA

17–20 June Society for Vascular Surgery (SVS) Vascular Annual Meeting Toronto, Canada

www.embolization.com

www.vascular.org

26–29 May New Cardiovascular Horizons (NCVH) New Orleans, USA

24–27 June European Conference on Embolotherapy (ET) Vienna, Austria

www.ncvh.org

24–25 April Merit Medical Think Radial course Miami, USA www.merit.com/education

30 April–1 May British Society of Interventional Radiology Advanced Practice course Manchester, UK

4–6 June International Conference on Complications in Interventional Radiology Poertschach, Australia www.cirse.org/events

www.etconference.org

12–16 September Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Annual Scientific Meeting Munich, Germany

1–3 October iWounds Symposium Chicago, USA www.iwoundssymposium.com

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

2–4 December British Society of Interventional Radiology (BSIR) Annual Meeting Glasgow, UK www.bsir.org/meetings

www.cirse.org

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

Mar

Issue

19 73

to continues elUS FDA paclitax investigatevices in the leg de d ate co

(JAHA) Association suggesting an Heart the Americ ) and colleagues, el-coated Journal of , Greece the use of paclitax ed in the debate g os (Patras months of still ongoing, nalysis publishntinos Katsan five years followin is A meta-a generated year by Konsta at two and artery, has The conversationon the future of late last ed risk of death popliteal nity. pointed t commu hosting discussion in the femoro an increas ans have the and stents tional interventionalis to date ent physici after balloons nce of 2019 then, promin published ted with the the interna amongst key vascular conferedevices. Since patient-level data y associa and ed mortalit also announced with every ed and -eluting have no increas methodology, by the US Medical revealed os et al’s paclitaxel-coat and Cook ed investigation in Katsan by industry have nic flaws out medtro nalysis the continu is not yet over. devices. story JAHA meta-a el-releasing Meanwhile, ed data. indicates that the use of paclitax (FDA) to their publish correctionsDrug Administration Food and

eiss: Laura Find

Profile

Page 30

acle: Alex Barn IR Paediatric

Page 32

Artificial intelligence will cause shift” “paradigm e in IR practic

ed for increas are calling n computer Clinicians and betwee engineers collaboration biomedical ists as machine scientists, oncolog more to play a interventional radiology is posited learning role in interventionalg the initial prominent ures, from informinselection (IR) proced through to patiente. In a diagnosis, cedural guidanc Journal The gy and intrapro published in tional Radiolo Forum recent primer Leaders Wang and r and Interven at the Vascular of Vascula Letzen, Clinton School of Panellists Leaders Forum (JVIR), Brian , all of the Yale outline the of the Vascular hosted floor the USA, n DC, USA), FDA peaking from Julius Chapiro e learning New Haven, (VIVA), March, Washingto Advances (VLF; 1–2 Medicine, of JAHA paper, tions of machinwhere c review Interventional has “reviewed most ing In the original conducted a systemati a future

by Vascular clinical applica , who trials investigat the al visualise -coated Katsanos et randomised controlled Donna Buckley, ded them to be approved” (AI) enables , for IRs, and or paclitaxel first 28 investigator intelligence In angioplasty and recommen perspective: “Our analysis of ne to become artificial to these devices body’s e of -coated balloon popliteal arteries. of the discipli the regulatory ysis was, I think, similar ss, paclitaxel in the femoral and/or nt claudication) were elevation ’s words, “the epitom explained Nonethele stents meta-anal metal the bit surprised. seriously.”

(89% intermitte in Chapiro was all-cause response to medicine”. were a little very all, 4,663 patients safety measure points. “Risk else’s: we personalised n that we took primarily everybody time The primary outline their informatio

S

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

g different analysed.

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

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

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

Interventional News is a trusted, independent source of news and opinion in the interventional world.

Sign up for a free print subscription* and e-newsletter subscription**

www.interventionalnews.com *Available for US and EU readers only ** Available worldwide