Interventional News Issue 78—September 2020 by BIBA Publishing

September 2020 | Issue 79

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Vertebroplasty: Australian Medicare page 12

Julius Chapiro & Lynn Savic: Soul-searching in IO

FEMME trial finds myomectomy improves quality of life more than UAE at two years

page 24

Six-month IN.PACT AV Access results show superiority of DCB angioplasty

Results from a multicentre, randomised controlled trial—FEMME—published recently in the New England Journal of Medicine (NEJM) indicate that myomectomy shows superior fibroidrelated quality of life at two years compared to uterine artery embolization (UAE) in women with symptomatic uterine fibroids. Several prominent interventional radiologists suggest that while gynaecologists may use this headline finding to cease recommending UAE, the treatment is still a good therapeutic option in patients with symptomatic fibroids. They highlight that informed patient choice is at the heart of personalised fibroid therapy.

Profile: Matthew Callstrom

“The results do not mean UAE is an inferior treatment to myomectomy” Anna-Maria Belli

saac Manyonda (St George’s, University Average quality of life scores at two of London, London, UK) and years were substantially improved in both colleagues’ publication coincided groups, but were greater in those assigned with Fibroid Awareness Month. July to myomectomy (mean-adjusted difference 2020 saw healthcare workers, hospitals, using complete case analysis: eight points; and other organisations promoting 95% confidence interval [CI], 1.8–14.1; uterine health, shining a spotlight p=0.01; mean-adjusted difference with “The six- to eight-point on an underexposed condition missing responses imputed: 6.5 points; 95% benefit on average in healththat one in three women will CI, 1.1–11.9). Mean quality of life score at two related quality of life scores experience in their lifetime. years from randomisation was 84.6±21.5 in the in the myomectomy group, The triallists set out myomectomy cohort, versus 80±22 in the UAE as compared with the UAE to compare the effect of group. group, is consistent with UAE and myomectomy on In total, 254 patients were recruited from 29 small to moderate quality of life in women hospitals, and randomly assigned to undergo standardised treatment with symptomatic fibroids myomectomy or UAE as the primary procedure benefit at two years”— Isaac Manyonda et al wishing to avoid hysterectomy. in a 1:1 ratio. Women were only eligible for The primary outcome measure enrolment if they were considered suitable for of the FEMME (Fibroids either procedure. with embolization or myomectomy to measure “The six- to eight-point benefit on average in healththe effect on quality of life) trial was the conditionrelated quality of life scores in the myomectomy group, specific quality of life domain score from the Uterine as compared with the UAE group, is consistent with Fibroid Symptom Quality of Life questionnaire (UFSsmall to moderate standardised treatment benefit at two QOL). Scores could range from 0–100, with higher years,” the authors write. “However, the 95% confidence numbers indicating a better quality of life. interval around these estimates indicates that plausible Continued on page 2

Just-published six-month results of the IN.PACT AV Access study show that drug-coated balloon (DCB) angioplasty is superior to standard angioplasty for the treatment of stenotic lesions in dysfunctional haemodialysis arteriovenous fistulas (AVFs). Furthermore, it was found to be non-inferior with respect to access circuit-related serious adverse events within 30 days. THESE RESULTS WERE PUBLISHED on 19 August in the New England Journal of Medicine (NEJM). Robert Lookstein (Mount Sinai Health System, New York, USA) and colleagues note that long-term outcomes for standard percutaneous transluminal angioplasty (PTA)—the current recommended treatment for dysfunctional haemodialysis fistulas—are poor. DCBs delivering the antirestonotic agent paclitaxel may improve outcomes, they write. In this prospective, single-blinded, 1:1 randomised trial, the investigators enrolled 330 participants across 29 sites in the USA, Japan, and New Zealand. Patients with new or restenotic lesions in native upper-extremity AVFs were eligible for participation. After successful high-pressure PTA, participants were randomly assigned to receive treatment with either the IN.PACT AV drugcoated balloon (Medtronic) or a standard balloon. Lookstein and colleagues detail that the primary effectiveness endpoint was target lesion primary patency, defined as freedom from clinically-driven target revascularisation or access-circuit thrombosis during the six months after the index procedure. They assessed the primary safety endpoint—serious adverse events involving the arteriovenous access circuit within 30 days—in a noninferiority analysis (margin of noninferiority 7.5 percentage points). Lookstein et al write that a total of 330 participants underwent randomisation, with 170 assigned to receive treatment with a DCB and 160 assigned to receive treatment with a standard balloon. Writing in NEJM, the authors report that, during the six months after the index procedure, target-lesion primary patency was Continued on page 4

September 2020 | Issue 79

Fibroid embolization

FEMME trial finds myomectomy improves quality of life more than UAE at two years

better suited to UAE. Some benefits of UAE are its ability to be performed under conscious sedation, as well as a shorter recovery time that may be bettersuited to young women with busy family and work commitments.” Contextualising the investigators’ decision to use UFS-QOL score as the primary outcome measure, Moss explains that quality of life Continued from page 1 results range from almost no benefit of myomectomy measurements are “included in almost all randomised over embolization to a moderate (15 point) difference.” controlled trials [RCTs]”. Early UAE trials, such as Despite the increased quality of life scores REST and EMMY (from Scotland and The Netherlands, in the myomectomy cohort, several respectively) used the SF36 interventional radiologists, including two questionnaire, which Moss “Although the quality of the study co-authors, have expressed describes as a “generic quality of life was higher in the to Interventional News that UAE is still a of life instrument”. myomectomy group and [this good option for patients with symptomatic Weighing in on difference was] statistically fibroids. Jonathan Moss (University of the primary outcome significant, it was only a few Glasgow, Glasgow, UK), a co-author of measure of the FEMME points better. Therefore, the NEJM study, comments: “Although the trial, James Spies (MedStar provided women understand quality of life was higher in the myomectomy Georgetown University this, then they can choose either procedure”— group and [this difference was] statistically Hospital, Washington, DC, Jonathan Moss significant, it was only a few points better. USA) comments: “The Therefore, provided women understand this, primary outcome was the then they can choose either procedure.” change in quality of life, and Fellow study author Anna-Maria the quality of life scores of the Belli (St George’s University myomectomy patients were worse at Hospital NHS Foundation baseline than the UAE group, despite “For some women, avoiding a general anaesthetic, having Trust, London, UK) echoes this the randomisation. If one looks at final a shorter hospital stay, and sentiment, telling this newspaper quality of life scores, they are very avoiding an open surgical that “The results show a substantial comparable within the sensitivity of the procedure is of paramount benefit to treatment in both groups questionnaire used, but the study was importance, in which case with regard to quality of life and designed to use the change in scores as UAE would be their preferred symptom severity, even though the primary outcome [Spies’ emphasis]. option”—Anna-Maria Belli the results for myomectomy were Thus, somewhat artefactually, better than UAE.” However, there was a greater improvement in she adds that she believes “The quality of life scores for myomectomy. results do not mean UAE is an inferior If one compares final quality of life treatment to myomectomy. scores or symptom scores, there would have been no “With regard to menstrual blood loss, the results difference.” in both groups were comparable. This means that The authors acknowledge that the presence of some women should be offered either treatment and choose baseline differences in health-related quality of life for themselves. For some women, avoiding a general and age between the two groups is a limitation of anaesthetic, having a shorter hospital stay, and their analysis, but note that prespecified analyses were avoiding an open surgical procedure (the majority of adjusted for the baseline health-related quality of life, myomectomies in FEMME were open abdominal as and a post-hoc analysis adjusted for age showed similar fibroid and uterine sizes were large) is of paramount findings. importance, in which case UAE would be their preferred Spies describes FEMME as “an important study, one option.” of the very few randomised trials comparing Gerard Goh (The Alfred Hospital, Melbourne, myomectomy versus UAE. It shows very comparable Australia) also enumerates the benefits of UAE: outcomes of both procedures in terms of symptom “Individualised medicine, i.e. tailoring treatment to control, quality of life, complications, and in the limited the patient, is an important part of patient care, and as fertility outcomes. Overall, I congratulate the authors on interventional radiologists we are able to offer patients completing an outstanding study, which validates UAE an alternative treatment to surgery. Even before the as an effective therapy that yields comparable outcomes FEMME trial was published, we knew that there were in this population of patients.” some patients better suited to myomectomy, and some Continued on page 4

News in brief

The latest stories from the interventional world

n DIVERSITY AND INCLUSION: In response to the global outcry following the murder of an unarmed black American, George Floyd, by police in Minneapolis in May of this year, and as a contribution to the continuing conversation on racism in the USA and globally, the Society of Interventional Radiology (SIR) released a statement committing to anti-racist efforts. Interventional News speaks with SIR Diversity and Inclusion Advisory Council chair Paul J Rochon about this.

For more on this story go to page 8. n PROSTATE ARTERY EMBOLIZATION: Repeat prostatic artery embolization (PAE) is safe and effective for recurrence of lower urinary tract symptoms (LUTS) or acute urinary retention caused by benign prostatic hyperplasia (BPH), and may be used as a first-line treatment option. However, it has limited impact in patients who did not show a response to the initial embolization procedure. This is the conclusion presented by Nuno Costa (Saint Louis Hospital, Lisbon, Portugal) et al in their recent publication in the Journal of Vascular and Interventional Radiology (JVIR).

For more on this story go to page 10. n VERTEBROPLASTY : The Australian Medicare Services Advisory Committee (MSAC) has recommended restoring Medicare funding for vertebroplasty in patients with severely painful thoracolumbar fractures of less than three weeks duration. “MSAC accepted that vertebroplasty has a benefit in a small population of patients by helping them regain their mobility sooner and reducing pain in the short term,” reads the consumer summary.

For more on this story go to page 12.

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September 2020 | Issue 79

FEMME trial

FEMME trial finds myomectomy improves quality of life more than UAE at two years Continued from page 2

UAE and myomectomy result in comparable pregnancy rates, but numbers too small to call

In terms of fertility, there were no consistent differences between groups in the FEMME trial with regard to biomarkers of ovarian reserve. Nine women in the UAE group (8%) and five women in the myomectomy group (4%) reported pregnancies within two years of randomisation, resulting in six and four live births, respectively, the authors report. However, they note there are too few pregnancies amongst the trial cohort to inform the effects of the procedures on fertility. Expounding on the clinical implications of the two-year results, Moss relates: “We found no evidence of ovarian damage using several markers after either procedure. The number of pregnancies was low in both groups. The pregnancy data is difficult to interpret, and the intention to treat (ITT) and per protocol analysis showed no difference [between the UAE and myomectomy groups]. Interestingly, if you look at the women who actually received UAE, there were slightly more pregnancies than in those who actually had myomectomy. However, the numbers are small, and one cannot draw any firm conclusions.” Belli believes that an “important aspect” of the trial is that the results reveal “no adverse effect on ovarian reserve from UAE, which opens up the potential for further research in younger women wishing to become pregnant”. She notes that the average age was 40 in the trial, “so low pregnancy rates are not so surprising”. Belli adds: “Also, this trial reflects the real population of women suffering from symptomatic fibroids, with a high proportion of black women and large fibroid uteruses (mean >1,000cc).” “There is a surprising amount of resistance from the gynaecological community across the world about offering UAE to women who wish to maintain their fertility,” Moss opines. Prior to the FEMME trial, Moss outlines how “several smaller RCTs compared these two techniques, but the numbers were small and results conflicting. Some, such as FUME, had to exclude women wishing to become pregnant. FEMME overcomes most of these problems, even though the number of pregnancies is small, with limited

data on that outcome.” He further informs Interventional News that his research team are currently considering a large trial using pregnancy outcomes as the primary outcome measure, which they believe is needed. “It would have to be a trial of several thousand women, and probably an international effort,” he says.

with UAE was “a little surprising, as both procedures preserve the uterus”. However, UAE was associated with a shorter length of hospital stay: the median time spent in the hospital for an embolization patient was two days, compared with four days for a myomectomy patient. Belli articulates her opinion of these findings: “We knew that UAE had a greater repeat treatment Other secondary outcome measures rate, but the complication rate is no different between similar in both groups the two treatments, even though the blood transfusion In addition to fertility, other secondary outcome and haemorrhage rate was higher in the myomectomy measures were similar for both myomectomy group. I have always believed and UAE: menstrual bleeding scores, that getting rid of the large “Individualised medicine, peri- and postoperative complication rates, bulky fibroids [as with i.e. tailoring treatment to and the percentage of patients who would myomectomy] is ultimately the patient, is an important recommend their procedure to a friend. more satisfying for women part of patient care and as Specifically, at two years, the percentage than simply returning interventional radiologists of women who would recommend menstrual function and other we are able to offer patients an alternative treatment to myomectomy to a friend was 93%, fibroid symptoms to normal. surgery”—Gerard Goh versus 84% with UAE, while respective My happiest patients were percentages of women who said they would the ones who had the largest have the procedure again were 78% and reduction in bulk, despite 74%. counselling them that this Peri- and postoperative was not the main aim of “The primary outcome was the change complication rates for UAE.” in quality of life, and the quality of life both procedures were However, reflecting scores of the myomectomy patients were low, Manyonda et al relate, with on the impact of worse at baseline than the UAE group, one conversion of a myomectomy these FEMME trial despite the randomisation. If one looks to a hysterectomy, and one data, Belli adds: “I at final quality of life scores, they are very conversion from a laparoscopic hope that the results comparable within the sensitivity of the questionnaire used, but the study was to an open myomectomy. At of this trial will make designed to use the change in scores as six months postprocedure, 32 gynaecologists more the primary outcome. Thus, somewhat of 80 (40%) fibroids treated by accepting of UAE as artefactually, there was a greater embolization were completely an alternative, and improvement in quality of life scores infarcted. Peri- and postoperative allow a larger trial to for myomectomy. If one compares final complications from all initial address pregnancy rates quality of life scores or symptom scores, procedures occurred in 34 out and outcomes to go there would have been no difference”— of 118 patients (29%) in the ahead. Unfortunately, James Spies myomectomy arm, and in 27 out I am afraid some of 113 patients (24%) in the UAE gynaecologists might group (relative risk, 1.2; 95% CI, simply read the headline 0.8–1.9; p=0.4). result and use this to confirm their prejudices and Furthermore, a “substantially” greater number not even offer UAE.” of patients in the UAE group underwent additional Moss concurs, commenting that “trying to procedures within two years of follow-up: 18 of the ‘open many closed minds’ was the largest barrier” 110 patients with two-year data (16%), versus eight of to running this trial. “At times it felt like trying to the 111 women (7%) in the myomectomy cohort. “This persuade someone to change their religion,” he says, “so observation may be explained in part by the lower firmly held are some views. Triallists, however, must quality of life reported in the UAE group,” Manyonda et never give up, and having a strong team, like we did, is al muse. “However, more hysterectomies were essential. performed as the initial procedure in the myomectomy “My message on the results it that UAE has some group, owing either to patient preference or clinical advantages, such as avoiding an incision, a general decision.” anaesthetic, and more rapid recovery. In my view, it is Moss acknowledges that the higher reintervention rate for fully-informed patients to make their own choice.”

Six-month IN.PACT AV Access results show superiority of DCB angioplasty Continued from page 1

maintained more often in participants who had been treated with a DCB than in those who had been treated with a standard balloon (82.2% [125/152] vs. 59.5% [88/148]; difference in risk, 22.8 percentage points; 95% confidence interval [CI] 12.8–32.8; p<0.001). In addition, they found that DCBs were noninferior to standard balloons with respect to the primary safety endpoint (4.2% [7/166] and 4.4% [7/158], respectively; difference in risk, -0.2 percentage points, 95% CI -5.5–5; p=0.002 for noninferiority). In the NEJM paper, Lookstein et al detail that there has been a wide

adoption of continuous haemodialysis through autologous AVFs. However, this has been associated with a high incidence of dysfunction caused by vascular stenosis within the fistula circuit, leading to inadequate haemodialysis. Lookstein and colleagues acknowledge some limitations of the present study. For example, they note that the DCB has a different appearance than a standard balloon, which made a double-blind trial design “unfeasible”. In addition, the investigators recognise that further studies will be required to evaluate the safety and effectiveness

of DCBs for the treatment of central vein obstruction, in-stent restenosis, or arteriovenous graft stenosis, as they investigated only lesions in AVFs. “Improvements in patency could potentially have significant benefits for patients, leading to longer periods of successful and uninterrupted dialysis, as well as reducing the use of catheterbased dialysis and the substantial incidence of adverse events associated with this type of dialysis.” Speaking to Interventional News, Lookstein comments on the clinical implications of the study: “We now have Level 1 evidence of a simple technology that is proven to be safe and effective at improving outcomes for patients with end-stage renal disease [ESRD] on haemodialysis.” He continued: “This is the first US Food and Drug Administration [FDA]-

approved paclitaxel-based device since the controversy last year, which is a testament not only to the incredible results seen in this trial, but also the significant needs of this population.”

This is the first US Food and Drug Administration [FDA]-approved paclitaxel-based device since the controversy last year.”

September 2020 | Issue 79

Uterine artery embolization

FEMME TRIAL FOCUS

Responding to the FEMME trial: “UAE should be considered whenever myomectomy is proposed” James Spies Comment & Analysis Responding to the results of the FEMME (Fibroids with embolization or myomectomy to measure the effect on quality of life) trial, James Spies suggests that uterine artery embolization (UAE) is a favourable treatment option over myomectomy in many patients, as they take into consideration the recovery times and weigh up the benefits of having a minimally invasive procedure versus undergoing an open, operative one. “The important takeaway from the study is that both these treatments are highly effective and they produce comparable outcomes in this population,” he writes.

ith the recent publishing of the FEMME trial outcomes in the New England Journal of Medicine, we gained additional insight into the outcomes of UAE, this time in a head-to-head comparison with myomectomy. Myomectomy has had growing acceptance in recent years as a first choice among surgical options for fibroids. Where myomectomy used to be limited to those who wished to have children in the future, there is a growing body of data suggesting that outcomes are similar to hysterectomy in women beyond their primary childbearing years, and it has been promoted by some in the gynaecology community as a preferred uterine-sparing treatment. It is in this context that we evaluate the FEMME study.

At first glance, some might be disappointed that the primary outcome from this study, the change in the quality of life score from the UFS QOL, showed a modest advantage for myomectomy, about eight points on a scale of 0 to 100. Higher scores on this scale reflect better quality of life. This

modest difference at best, not reflecting a clinically important difference. As the authors note, the confidence interval suggests a range from no difference to a moderate 15-point difference. The second important point is that, despite randomisation, the myomectomy group had lower baseline quality of life scores. This is a statistical aberration but with a direct impact on the primary outcome, which was the change in quality of life score. The final quality of life score was 80 for UAE patients and 84 for myomectomy patients, a minimal difference, below the threshold of what constitutes a clinically-important difference for this questionnaire. Finally, the more important measure on this questionnaire is the symptom score, which also showed a small, not clinically-important difference at six months in favor of myomectomy and no statistically significant difference at 12 months and two years. These findings confirm an earlier study using the same questionnaire comparing the outcomes of UAE, myomectomy, and hysterectomy with normal controls, in which myomectomy and UAE had similar quality of life and symptom scores.

UAE “highly effective”

So, the final scores are comparable, as were the safety and the limited fertility outcomes. The important takeaway from the study is that both these treatments are highly effective and they produce comparable outcomes in this population. When women choose a treatment for fibroids, they take a range of factors into consideration, including the outcomes mentioned, but also the time for recovery and time away from normal activities. In most cases, they will be comparing open

Despite randomisation, the myomectomy group had lower baseline quality of life scores.” was the primary conclusion reported in the abstract. However, when one looks closer some important points become clear. First, an eight-point difference is a

operative myomectomy to a minimally invasive procedure, and many women are likely to believe that UAE is a better choice for them.

Lobbying at social and political levels “crucial” to raise UAE profile

“Unnecessary hysterectomies” could be avoided by involving interventional radiologists at gynaecology multidisciplinary team meetings and in the patient counselling process, Gregory Markris, Saqib Butt, and Tarun Sabharwal (all Guy’s and St Thomas’ Hospital, London, UK) write in a Letter to the Editor in Cardiovascular and Interventional Radiology (CVIR) Endovascular. CITING A 2019 ARTICLE BY ANNEFLEUR DE Bruijn (Vrije Universiteit Amsterdam, Amsterdam, The Netherlands) and colleagues that concluded that adding uterine artery embolization (UAE) as a treatment option to the national Dutch guidelines did not change

the number of performed UAEs for symptomatic fibroids, Makris et al claim: “Such low UAE rates are not isolated to The Netherlands”. As previously reported in this newspaper, approximately 145 UAEs are performed annually in Spain, a country with a

Having said that, the FEMME trial was not powered to address reproductive outcomes and, despite comparability in the very limited data presented, we cannot conclude that the reproductive outcomes are the same. There has only been one randomised trial reporting on reproductive outcomes of UAE versus myomectomy, and it showed an advantage for myomectomy. However, the data were not strong, and this lead the most recent Cochrane Review in 2012 to conclude that there was weak evidence favoring myomectomy over UAE for those seeking to become pregnant—to quote: “There was some indication that UAE may be associated with less favourable fertility outcomes than myomectomy, but it was very low quality evidence from a subgroup of a single study and should be regarded with extreme caution (live birth: odds ratio [OR], 0.26; 95% confidence interverval [CI], 0.08–0.84; pregnancy: OR, 0.29; 95% CI, 0.10–0.85, one study, 66 women”. The FEMME trial investigators are to be congratulated on completing a randomised trial comparing these two therapies. The study has contributed significantly to our knowledge of these two therapies, demonstrating that the two procedures provide very similar outcomes and, while each patient’s circumstances are different, UAE should be considered whenever myomectomy is proposed. James B Spies is an interventional radiologist at MedStar Georgetown University Hospital, Washington, DC, USA. References: 1. Manyonda I, Belli AM, Lumsden MA, Moss J, McKinnon W, Middleton LJ, et al. Uterine-Artery Embolization or Myomectomy for Uterine Fibroids. N Engl J Med. 2020;383(5):440-51. 2. Wallace K, Zhang S, Thomas L, Stewart EA, Nicholson WK, Wegienka GR, et al. Comparative effectiveness of hysterectomy versus myomectomy on one-year healthrelated quality of life in women with uterine fibroids. Fertil Steril. 2020;113(3):618-26. 3. Spies J, Bradley L, Guido R, Maxwell GL, Levine BA, Coyne K. Outcomes for leiomyoma therapies: Comparison with normal controls. Obstet Gynecol. 2010;116:641-52. 4. Mara M, Maskova J, Fucikova Z, Kuzel D, Belsan T, Sosna O. Midterm clinical and first reproductive results of a randomized controlled trial comparing uterine fibroid embolization and myomectomy. Cardiovasc Intervent Radiol. 2008;31(1):73-85. 5. Gupta JK, Sinha A, Lumsden MA, Hickey M. Uterine artery embolization for symptomatic uterine fibroids. Cochrane Database Syst Rev. 2012;5:CD005073.

population of over 44 million, and in France, there is an average of 2,000 UAEs performed each year, compared to 40,000 hysterectomies per annum. “This is concerning,” Markris et al opine, “especially in light of trial evidence showing that two thirds of women treated with UAE remain hysterectomy free at 10 years”. Makris, Butt, and Sabharwall believe that promoting awareness of UAE amongst patients, and closer collaboration between interventional radiologists and gynaecologists, will help to raise the number of UAE patients. They say: “The interventional radiology community must continue to address the injustice of chronic underutilisation of this minimally invasive, safe, clinically and cost-effective procedure. Engaging with relevant stakeholders and lobbying at social and political levels is crucial for the success of this endeavour.”

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PERIPHERAL

September 2020 | Issue 79

Diversity and inclusion

SIR’s focus on diversity and inclusion: “There needs to be representation at all levels” In response to the global outcry following the murder of an unarmed black American, George Floyd, by police in Minneapolis in late May of this year, and as a contribution to the continuing conversation on racism in the USA and globally, the Society of Interventional Radiology (SIR) released a statement of commitment in support of diversity within medicine. It promised to “commit to anti-racist efforts, policies, and programmes that aim to increase the numbers of underrepresented minorities and women within our specialty”. Interventional News spoke with Paul J Rochon, chair of the SIR Diversity and Inclusion Advisory Council and a vascular and interventional radiologist at the University of Colorado School of Medicine, Aurora, USA, about the society’s continued anti-racist activities and intentions.

How is the SIR supporting diversity and combating racial inequality in the USA?

As we outlined in our statement, SIR has a number of activities underway to combat racial inequality. In addition to establishing the Diversity and Inclusiveness (D&I) advisory group and the Women in IR (WIR) section—both of which bring a powerful diverse voice to SIR’s leadership—the society and SIR Foundation offer a variety of grant programmes for medical students from diverse backgrounds to participate in clerkships that fund research by women and underrepresented minorities, and that fund the establishment and validation of programmes that aim to diversify the workforce. We also established a Speakers Bureau to ensure meeting planners have access to IR experts from underrepresented groups.

What strategies have been identified as essential to recalibrate any systemic imbalances within medicine and IR? The formation of active diversity, equity, and inclusion committees and boards in institutions, both academic and private, is the first strategy. All specialties should have these incorporated. As this happens, specialties should come together in their efforts and strategies to recalibrate these systemic imbalances.

Workplace diversity (particularly of gender and race) is distinctly underrepresented in IR. Why do you think this is, and what actions is SIR taking to engage with this issue?

One of the biggest challenges facing IR is awareness of the specialty. For years, it was a subspecialty of radiology, and did not have that much exposure outside of radiology rotations. IR’s status as a primary specialty in the USA and its associated residency programmes are fairly new, but it is raising the profile of IR, which will hopefully help us recruit more people of diverse backgrounds into the specialty. The MATCH results are encouraging in that we remain among the most competitive specialties. We have routinely filled more than 98% of slots each year. To help with recruitment among medical students, SIR’s D&I advisory group’s recruitment committee, in collaboration with SIR’s Residents, Fellows, and Students (RFS), WIR, and Association of Program Directors in Interventional Radiology (APDIR) sections, have been working to plan strategies related to ensuring that female and underrepresented minority medical students and undergraduates are aware of IR as a specialty option. Through SIR Foundation, and a generous endowment from Alan Matsumoto and his family, we have issued grants to help people from underrepresented backgrounds participate in IR clerkships. The funding is critical to ensuring that those in various underrepresented groups are able to access the networking opportunities clerkships provide and be

exposed to IR as a career path. It will be some years before we train enough new interventional radiologists to build a truly diverse workforce, but in the meantime, we are working hard to raise the voices of those underrepresented in our workforce. SIR has been collecting Paul J Rochon member demographic information for over five years; these data include gender and ethnicity, and cover all career stages, from medical student through to attending. The D&I advisory group has been reviewing this data as it relates to overall SIR membership, committee engagement, and speakers at its educational meetings, and is working to ensure that these posts and opportunities are accessible to people of diverse backgrounds. Additionally, it is part of SIR’s strategic plan to conduct a study on the IR workforce, which will entail an overall look of the workforce trends and include insight on practice types, gender, and underrepresented minorities. This will further help us to tailor programmes to ensure we are effectively including all voices and views in all SIR activities. All in all, it all stems from intentionality. Workplaces need to not check boxes; strategic plans should be in place to recruit diversity in gender and race and ensure inclusion.

Could you elaborate on the role of the Women in IR committee and the Diversity & Inclusion committee within SIR?

Together, the WIR section and D&I advisory group promote diversity of gender, race, and ethnicity within SIR. The two groups collaborate to increase the participation and visibility of women and underrepresented minorities (URM) in SIR, as well as fostering the growth and awareness of women and URM in IR. It is expected that these initiatives will enhance our specialty and strengthen our society.

How do you describe to others why a Diversity and Inclusiveness advisory group is needed?

The success of our mission as a society draws strength not just from the clinical expertise of our physicians, but from the diversity of their backgrounds and experiences as human beings in the world. An innovative, competitive IR workforce requires more than market competencies—it must also carry the power of innate, authentic human connection. As a specialised group of medical practitioners, the diversity of our members and

the patients they treat every day is of utmost importance to the overall health of our specialty. SIR’s commitment to these principles must be active and consistent. Having a dedicated D&I advisory group comprised of members and committees that are working across the society helps to ensure that diversity and inclusiveness is an active, living part of SIR’s culture and its work.

SIR has a limited number of grants for women and physicians who are underrepresented in medicine. What has the impact of these schemes been to date?

SIR and SIR Foundation have launched several programmes to encourage students of diverse backgrounds to enter into IR as their specialty. One of the key programmes, which I alluded to above, is the Grants for Education of Medical Students (GEMS), which was launched in 2019 thanks to the support of Alan Matsumoto and his family, as well as corporate partners. This scholarship programme allows up to 10 applicants from a variety of disadvantaged backgrounds to participate in an away clerkship rotation in IR. Since its establishment in mid-2019, the GEMS programme has awarded seven medical students with US$10,500 in funding to participate in clerkships, and another US$7,000 in funding for travel to the SIR annual meeting, where they will be able to network with interventional radiologists and learn about the specialty. By the end of this year, we hope to increase that funding to US$16,500 and US$11,000, respectively. Due to the impact of COVID-19, the GEMS programme will be going virtual for a six-week course with a heavy health equity and diversity component. Each scholarship and travel stipend will still be paid out to the students for this year. In addition, the GEMS programme will also be issuing IR textbooks to the recipients and GEMS instructors from its endowment. By the end of this year, the 2020 GEMS recipients will submit a Journal of Vascular and Interventional Radiology (JVIR) white paper outlining their vision for IR’s role in achieving healthcare and education justice moving forward as part of a group project during their GEMS curriculum. In addition to this programme, SIR has an SIR Speakers Bureau, which aims to increase the visibility of URM and women nationally. The Speakers Bureau list is used to identify potential speakers for national and regional meetings, as well as invited guest speakers. Grants are available through the diversity and inclusion grant programme to defray the travel costs associated with speaking engagements.

How can SIR members help promote diversity and inclusivity in their own institutions?

Development of and/or involvement in diversity, equity, and inclusion committees in their own institutions is how SIR members can help promote diversity and inclusivity. The old saying of “it starts at home” cannot be truer for this endeavor.

In your opinion, how should a national society balance supporting the grassroots activism of its members with a top-down approach of implementing specific schemes and recommendations?

A national society should balance grassroots activism with a top-down approach by bridging the gap between both. While the grassroots efforts may be involved in producing resources to educate members and increase awareness, leadership of a national society should embrace, advocate, and support, in addition to incorporating them into all aspects of the society, leadership and executive committees not excluded. There needs to be representation at all levels. Pipeline programmes for underrepresented minorities and women should be established to get more representation in leadership and executive committees.

September 2020 | Issue 79

10 Prostate artery embolization

REPORT

Repeat PAE: Safe and effective for patients who initially responded positively to embolization

best treatment options, one should have a clear idea on the potential outcomes from repeat PAE. We have previously shown [in a 2016 Radiology paper by Bilhim et al] that patient selection is important to improve outcomes.” Up to 20% of PAE patients undergo repeat intervention after one year, with a minority of clinical failures occurring in patients who experience symptom relapse after initial improvement (80% of clinical failures never show any improvement post-procedurally, and are in the nonresponders category of this study). By demonstrating the safety and efficacy of repeat PAE, the investigators hope that this clinical study sheds some light on the treatment options available for patients who are deemed clinical failures

Baseline prostate volume—patients with a prostate volume <40cc have worse clinical outcomes. However, outcomes are not significantly different for patients with a prostate volume >40cc (including large or very large prostates). This means that larger prostates do not necessarily mean better outcomes. It is rather the other way around. Smaller prostates do worse after PAE. Avoid pedunculated median lobes— avoid all prostates with a median lobe morphology that is taller than wide. Patients under acute retention and large CG adenomas are good candidates— patients with prostate morphology with a central gland that is responsible for more than 50% of the whole

Repeat prostatic artery embolization (PAE) is safe and effective for recurrence of lower urinary tract symptoms (LUTS) or acute urinary retention caused by benign prostatic hyperplasia (BPH), and may be used as a first-line treatment option. However, it has limited impact in patients who did not show a response to the initial embolization procedure. This is the conclusion presented by Nuno Costa (Saint Louis Hospital, Lisbon, Portugal) et al in their recent publication in Journal of Vascular and Interventional Radiology (JVIR).

he study investigators set out to evaluate the safety and efficacy of repeat PAE for LUTS caused by BPH, to define revascularisation patterns, and to establish predictors of outcome in larger cohorts of treated patients. Costa and colleagues conducted a single-centre, retrospective study investigating 108 patients with BPH and clinical failure after PAE who then underwent repeat PAE between June 2009 and October 2018. Of these 108, 39 did not show a response to their initial PAE, and 69 had an initially favourable response in the first six months following PAE, but then experienced relapsing symptoms. Clinical failure after initial PAE, as seen in the 39 non-responders, was defined as improvement in International Prostate Symptom Score (IPSS) after PAE of less than 25%, an IPSS after PAE of more than 15 points, no improvement in quality of life related to LUTS or a quality of life score greater than three

Tiago Bilhim

points, acute urinary retention after PAE, and need for any additional medical or invasive therapy for LUTS. The cumulative probability of clinical success at 12 months following repeat PAE was higher for patients who initially responded positively to embolization and were subsequently treated for a recurrence of initial symptoms than for patients who did not show a response at all to initial PAE: 56.7% versus 28.2%. Indeed, for patients with symptom relapse after initial PAE, the clinical outcomes were comparable to those reported for PAE: mean IPSS improvement of 9.5 points, mean quality of life improvement of 1.3 points, and clinical success rates of 84% at one month, and more than 50% at mid-term and long-term follow-up appointments. Costa et al suggest that “these results may justify repeat PAE”. They continue: “Of note, the subjective parameters of LUTS (IPSS/ quality of life scores) were not the only improvements noted after repeat PAE. Objective parameters such as prostate volume, postvoid residual volume, peak urinary flow [Qmax], and prostate-specific antigen level also showed significant improvements after repeat PAE.” They point out that the difference between nonresponders and relapsers after repeat PAE were only observed in the IPSS/quality of life analyses. Speaking to Interventional News, Tiago Bilhim (Saint Louis Hospital, Lisbon, Portugal), a co-author of the JVIR paper, says: “This study is important because it is not uncommon to follow up patients after PAE that still have residual LUTS and that may need additional treatments. These treatment options include medical management, surgery, and repeat PAE. In order to advise patients that still have LUTS after PAE about the

Normal prostate (L)

following embolization. “The present study […] expands on the concept that not all patients respond to PAE the same way, and that patient selection plays a pivotal role in improving clinical outcomes,” the authors note. “Even with a technical success rate of 100% and a unilateral repeat PAE rate lower than 6% (similar between relapsers and non-responders), clinical outcomes in non-responders were inferior to those reported for PAE. Even though as many as 17% of patients who never showed a response to PAE may still exhibit clinical success 24 months after repeat PAE, the vast majority of these patients do not show improvement. Therefore, repeat PAE should probably be avoided in patients who do not show a response to initial PAE.” Expanding on this idea, Bilhim tells this newspaper: “In this study, we prove once more that patient selection rather than PAE technique has a profound impact on outcomes. PAE is not a ‘perfect fit’ in all patients with LUTS and BPH, with up to 25% of clinical failures despite optimal technique. Correlation of clinical outcomes after PAE with prostate volume reduction are not clear, with many patients improving LUTS with minimum prostate volume reduction and vice versa. We now know that patient factors play a role. A lot of studies exist nowadays looking at predictors of clinical outcome for PAE.”

Some identified predictors of clinical outcome listed by Bilhim include:

Enlarged prostate (R)

prostate volume, with large central gland adenomas and those under acute urinary retention have very good outcomes with PAE. Old patients—possible to have worse outcomes and more challenging PAE procedures Patients with very severe baseline IPSS scores (>23 points) have a higher risk of clinical failure—PAE induces a mean IPSS reduction of 12–15 points. If your baseline is 30 points, this means that the probability of ending up with residual LUTS (>15 points) after PAE is very high. Again, this is important when counselling patients.

The embolization procedure

Patients were treated in an outpatient setting by a team of experienced interventional radiologists: two with nine years of experience with PAE each, one with four years experience, and one with one years experience. PAE was performed under local anaesthesia by a unilateral or bilateral femoral approach “wherever feasible”, the authors describe, stating that this was “usually through the right femoral artery”. In total, a unilateral femoral approach was used in 101 patients, and a bilateral approach in seven patients. Embolization was performed with different embolic agents, including: non-spherical polyvinyl alcohol (PVA) particles (100–300μm), spherical PVA particles (Bead Block 100–300μm and 300–500μm; BTG International), trisacryl gelatin microspheres (Embosphere 100–300μm and 300–500μm; Merit

Issue 79 | September 2020

Prostate artery embolization 11

Even though as many as 17% of patients who never showed a response to PAE may still exhibit clinical success 24 months after repeat PAE, the vast majority of these patients do not show improvement. Therefore, repeat PAE should probably be avoided in patients who do not show a response to initial PAE.” Medical), and Polyzene-coated hydrogel microspheres (Embozene 250μm and 400μm; CeloNova). Repeat PAE was considered more technically challenging than the initial embolization procedure: at 75 minutes (range: 20–120 minutes), the median procedure time of the repeat embolization was significantly higher versus initial PAE. Microspheres were used more often in repeat PAE procedures than the initial embolization, but Costa et al acknowledge that this “reflects a temporal trend rather than an intended method”. There were no major complications. Among the 108 patients, 104 (96.3%) were discharged three to six hours after PAE, and the other four (3.7%) spent the night in the hospital and were discharged the next morning (18 hours later) per personal preference. The endpoint of embolization was occlusion of all vessels to the prostate and reflux toward the prostatic artery. Embolization of at least one prostatic artery was considered a technically successful repeat PAE—repeat PAE was technically successful in all patients.

A decade of PAE data demonstrate the procedure’s efficacy

Ten-year data published in Radiology by Francisco Carnevale (University of São Paulo Medical School, São Paulo, Brazil) and colleagues this summer, and previously reported in this newspaper, show that PAE is a safe and effective treatment for men with BPH, which can result in long-term improvements in LUTS and quality of life. These most recent data from Bilhim et al on the safety of repeat PAE builds on a now fairly deep foundation of evidence that supports the idea that PAE is no longer an “experimental” procedure. Carnevale describes PAE “as another alternative for patients suffering from LUTS related to BPH”. Specifically addressing doubters of PAE, Carnevale says: “According to the Hippocratic oath, physicians should ‘Apply dietetic measures for the benefit of the sick according to their ability and judgement’. Interventional radiologists have faced turf battles for decades when aiming to bring new alternative treatments for patients. This happened with peripheral angioplasty, fibroid

embolization, and abdominal aortic aneurysm repair, among others, and it will not be any different with PAE. We are not saying that PAE is the only or the best treatment for LUTS related to BPH. We have simply brought another option for patients and physicians to discuss. Each treatment has its indications and contraindications, and it is necessary to understand the patient’s aims and wishes. The publication of these exciting results from our 10-year experience of PAE is a great achievement, and should be considered by the medical community. Its time is now.” This comment comes amidst the struggle PAE has faced to be included in global urology guidelines. In 2018, results of the UK ROPE study, which compared embolization to conventional prostate surgery, led the National Institute of Health and Care Excellence (NICE) to determine that the evidence on the safety and efficacy of PAE for BPH was adequate to support the use of this procedure on the National Health Service (NHS). They recommended the procedure “provided that standard arrangements are in place for clinical governance, consent and audit”. Nevertheless, the European Association of Urology (EAU) guidelines for the diagnosis and treatment of men with LUTS/BPH have not been updated, and remain cautious when describing the potential clinical role of PAE. They state: “A multidisciplinary team approach of urologists and radiologists is mandatory as the basis for future randomised controlled trials of good quality with long-term follow-up in order to integrate this treatment option into the spectrum of efficient, minimally invasive treatment options.” Since then, a 2019 study published in European Urology from Bilhim et al has demonstrated that improvements in quality of life measurements and IPSS are “far superior” following PAE than due to any placebo effect. A US Food and Drug Administration (FDA) review in 2017 concluded that “the probable benefits [of PAE] outweigh the probable risks for this indication”. However, PAE is not recommended outside of a clinical trial in the American Urological Association (AUA) guidelines, something many interventional radiologists refute.

September 2020 | Issue 79

12 Vertebroplasty

REPORT

Vertebroplasty to receive Medicare funding in Australia The Australian Medicare Services Advisory Committee (MSAC) has recommended restoring Medicare funding for vertebroplasty in patients with severely painful thoracolumbar fractures of less than three-weeks duration. THE MSAC IS AN INDEPENDENT, NONstatutory committee that appraises new medical services proposed for public funding, and provides advice to the Australian government on whether a new medical service should be publicly funded (and, if so, under what circumstances) on an assessment of its comparative safety, clinical effectiveness, cost-effectiveness, and total cost, using the best available evidence. Interventional News has been informed by an Australian interventional radiologist that, following the MSAC recommendation, “It is now a formality that parliament will approve a Medicare item number for vertebroplasty”. The MSAC recommendation comes after the Interventional Radiology Society of Australasia (IRSA) submitted an application to the Department of Health requesting the reinstatement of Medicare Benefits Schedule listing for vertebroplasty for severely painful osteoporotic thoracolumbar vertebral fractures of threeweeks duration or less in Australia, which was discussed at the 78th MSAC Meeting, on 3 April 2020. MSAC’s advice to the Minister reads: “After considering the strength of the available evidence in relation to its safety, clinical effectiveness and costeffectiveness, MSAC supported public funding for vertebroplasty for severely painful thoracolumbar osteoporotic fracture of three-weeks duration or less, as suggested during the MSAC Stakeholder Meeting on Vertebroplasty held on 7 June 2019. MSAC also advised that a prospective registry be developed to monitor this listing.” Vertebroplasty is defined in the MSAC recommendation document as “A procedure in which acrylic cement is injected into a bone of the spine to treat a break (fracture) where the bone was already weakened due to osteoporosis, and where the break has resulted in pain and limited mobility affecting quality of life.”

“MSAC accepted that vertebroplasty has a six-week limit for facture duration was later modified by benefit in a small population of patients by helping consensus between MSAC and IRSA to three weeks. them regain their mobility sooner and reducing MSAC considered this application for relisting pain in the short term,” states the consumer vertebroplasty in a November 2018 meeting, but did summary. “However, MSAC noted that the cost- not support pubic funding for vertebroplasty due to the effectiveness of vertebroplasty is uncertain. MSAC committee being “uncertain of its clinical significance”. also considered that the procedure might be used They did, however, acknowledge that there may be “a in patients for whom there is no evidence of any small clinical benefit” from vertebroplasty. benefit. Therefore, MSAC advised that the use of In March 2019, MSAC again considered the vertebroplasty be limited to those patients with application, but deferred its advice until a stakeholder recent and severely painful fractures of a certain meeting could be held, as the body believed this would type and location. The Committee also suggested “provide a broader clinical perspective and patient input, that this use is monitored through a registry for at [and] could inform the uncertainties in the application”. least two years, so that information can be collected The June 2019 stakeholder meeting represented about who is receiving the treatment and the costs a turning point for vertebroplasty advocates. In the associated with that treatment. This will provide publicly-available minutes of this meeting, it is noted: data that MSAC can review in the future to ensure “One clinician commented that there is respect among that the procedure is being used appropriately his colleagues for the MSAC process. They feel it is according to these specified criteria.” fair and rigorous and prevents adoption of low-value practice and wastage of health funding. However, there Vertebroplasty and Medicare is some concern that the process is quite arduous, and funding: A timeline of events the difficulty of obtaining the evidence required may Vertebroplasty was listed on the Medicare discourage people from submitting applications for Benefits Schedule from 2005 to 2011 based on a services that may be beneficial. The clinician suggested recommendation in the 2005 MSAC report. The that MSAC needs to have procedural consistency in interim item number was to be reassessed by 2010. dealing with differences of opinion between professional MSAC completed its second review in April groups. They commented that vertebroplasty is an 2011 and did not recommend continued public established technique, and related that clinicians were funding based on two randomised controlled trials, achieving good results with it when it was previously published together in the New England Journal of funded. Clinicians were surprised when the 2009 Medicine in 2009, that did not appear to support randomised trials showed no benefit. [...] They expressed vertebroplasty. their disappointment that so far results of the VAPOUR An application for relisting vertebroplasty for trial had been combined with, and effectively ‘drowned severely painful osteoporotic vertebral fractures out’ by, the other trials. Other clinicians agreed that there of less than six-weeks duration on the Medicare is no rationale for combining data from the VAPOUR Benefits Schedule was submitted to MSAC after trial for patients in the acute phase with data from other the results of the VAPOUR randomised controlled trials in patients with chronic fractures.” trial were published in The Lancet in 2016. The MSAC then gave their funding recommendation.

VAPOUR trial results reinstate Medicare funding for vertebroplasty in Australia William Clark Comment & Analysis

Lead author of the VAPOUR trial (Vertebroplasty for acute painful osteoporotic fractures) William Clark discusses the recent history of Australian Medicare funding for vertebroplasty, detailing how the 2009 results of two negative trials resulted in the Medicare Services Advisory Committee (MSAC) pulling their financial backing of the procedure. He outlines how the VAPOUR trial identified a subset of patients who benefit from the minimally invasive procedure, and ultimately led to the reinstatement of Medicare funding nationally.

ur application for public funding of vertebroplasty in Australia was based on the VAPOUR trial. Medicare funding for vertebroplasty had been removed after two negative trials were published together in 2009. We felt that these trials had largely excluded the group of patients that we had been

treating in Sydney—patients with severe pain and early fractures, especially hospitalised patients. We conducted the VAPOUR trial to gather evidence in this patient group and the trial showed positive benefits from vertebroplasty. Consistent with the recent history of vertebroplasty debate, the Medicare

Issue 79 | September 2020 Services Advisory Committee (MSAC) assessment was shrouded in controversy. The MSAC was torn between the positive evidence of VAPOUR, which was specific for this application, and the negative findings of the Cochrane vertebroplasty review. The situation was complicated by the first author of the Cochrane review being a committee member of the MSAC. Timing of the Cochrane review appeared designed to influence the MSAC assessment. MSAC initially advised against funding vertebroplasty, citing negative findings of the Cochrane review. The Interventional Radiology Society of Australasia (IRSA) complained to the Australian government that the application had not received an impartial hearing and that the Cochrane review should have been excluded due to conflict of interest. VAPOUR authors have published a criticism that the Cochrane review misrepresented evidence from our trial.1 The MSAC agreed to reconsider the application and summoned a stakeholder meeting for vertebroplasty in June 2019, inviting additional input from a broader range of clinical, epidemiologic, and biostatistical experts. The consensus from this meeting supported public funding of vertebroplasty for a subgroup of patients with uncontrolled pain from acute thoracolumbar vertebral fractures of not more than three-weeks duration. This patient subgroup derived most benefit from vertebroplasty in the VAPOUR trial. It includes most of the patients who are hospitalised with osteoporotic spinal fracture pain. Early vertebroplasty can reduce pain and the reliance on opiate analgesia, with its attendant negative side-effects (delirium and constipation), which so often complicate management of these patients. It can change the natural history of the fracture by restoring height and preventing further collapse while the fracture is still soft and pliable. Two randomised trials have assessed vertebroplasty for patients with fractures of three weeks or less. Diamond and colleagues2 published findings of a subgroup analysis from the VAPOUR trial, looking at 93 patients (46 vertebroplasty, 47 placebo) who underwent an intervention within three weeks of fracture. Yang and colleagues3 published an open-label randomised trial of 107 patients (56 vertebroplasty, 51 control) for vertebroplasty performed within three weeks of fracture. Both trials showed significantly better pain reduction in the vertebroplasty group and worse complications in the control group. The authors of the VAPOUR trial are proud that we have helped identify a patient group likely to benefit from vertebroplasty. We encourage interventional radiologists to consider offering early vertebroplasty for patients with severe pain or immobility caused by osteoporotic vertebral fractures. Delay can mean missing the window of opportunity to change the natural history

Vertebroplasty 13 of the fracture to benefit these suffering patients. William Clark is an interventional radiologist at St George Private Hospital, Sydney, Australia. References 1. Clark W, Bird P, Diamond T, et al. The Cochrane vertebroplasty review misrepresented evidence for vertebroplasty with early intervention in severely affected patients. BMJ Evid Based Med. 2019 2. Diamond, T et al. Early vertebroplasty within three weeks of fracture for acute painful vertebral osteoporotic fractures: subgroup analysis of the VAPOUR trial and review of the literature. Eur Spine J. 2020 3. Yang EZ, Xu JG, Huang GZ, et al. Percutaneous vertebroplasty versus conservative treatment in aged patients with acute osteoporotic vertebral compression fractures. Spine 2016

Issue 79 | September 2020

Radioembolization 17

Novel use of Y-90 radioembolization could transform prostate cancer treatment In an entirely new endeavour for Yttrium-90 (Y-90) radioembolization, investigators from Northwestern University, Chicago, USA, have used the technique for the treatment of prostate cancer. “This is a new use for radioembolization, and an entirely new, more targeted treatment for prostate cancer,” Sam Mouli, who is leading the research group, tells Interventional News.

andeep Bagla (Prostate Centers USA and Vascular Interventional Partners NOVA, Falls Church, USA), course director of the STREAM meeting, which focuses on research at the vanguard of prostatic artery embolization (PAE) and musculoskeletal embolization, says of this novel use of Y-90: “It is the most cutting edge application of embolization going on right now, with extensive future long-term potential.” The research team, led by Mouli, set out to examine the potential role of intra-arterial radiotherapy in the setting of a large prostate and prostate cancer. “Radiotherapy has been a cornerstone of treatment for locally advanced prostate cancer for the last 30 years,” Mouli explains. “Despite several advances in the understanding and treatment of prostate cancer over this time, current therapies continue to be limited by significant toxicities, including risks of urinary, bowel, and erectile dysfunction following treatment. Patients continue to seek novel therapies that not only provide oncologic benefit, but also maximise quality of life. “We posited that we could use our experience with Y-90 radioembolization in the treatment of liver cancer, and adapt it to what we have learned from our PAE programme.”

current therapies. We hypothesised that targeted intra-arterial delivery of Y-90 microspheres could mitigate these off-target effects, while still delivering high-dose radiotherapy to the prostatic tissues.” Utilising the techniques learned from both PAE for benign prostatic hyperplasia (BPH), and Y-90 radioembolization for liver malignancies, half of the prostates of the 14 animals included in the preclinical feasibility study were treated with Y-90 radioembolization, while the untreated contralateral sides were used as the control. In this cohort, imaging follow-up performed at specific time-intervals demonstrated prostate gland size reduction in a dose-dependent fashion starting at two weeks’ post-embolization,

Prostate gland shrunk in early animal testing

Y-90 microspheres can be safely delivered to prostatic tissues delivering highly targeted radiation without the offtarget damage seen with current approaches.”

The research team utilised the same canine model that they had initially used to study PAE, this time investigating the potential role of Y-90 radioembolization for the treatment of prostate cancer in a dose escalation study. They specifically looked into radiation changes to the prostatic tissues, as well as the effects of radiation on surrounding organs, such as the bladder and rectum, in addition to the erectile nerves, vasculature, and soft tissues. Mouli describes the thought processes underpinning this early study: “External beam radiotherapy and transperineal brachytherapy are limited by nontarget radiation delivered to tissues surrounding the prostate, which is the source of the adverse event profile seen with

Sam Mouli

continuing to three months post therapy. There were no clinical adverse events throughout the follow-up period. In addition, the investigators report no evidence of nontarget embolization or of any radiation damage to the surrounding bladder, rectum, and erectile tissues on MRI and pathologic analysis. Expounding on the perceived importance of these early data, Mouli enthuses: “By demonstrating feasibility and safety in this model, we have shown that Y-90 microspheres can be safely delivered to prostatic tissues delivering highly targeted radiation without the off-target damage seen with current approaches. Additionally, given the radio-isotope characteristics of Y-90, this potentially offers a single-stage treatment option for patients. Current radiotherapy often requires multiple treatments over several weeks to deliver radiation safely.

Radioembolization tailored to treat the radiosensitive prostate

Radiation is a standard of care therapy for prostate cancer. However, Mouli says, current radiotherapy approaches are challenged by technical considerations, such as limited dosing due to the proximity of surrounding structures, and difficulty of brachytherapy seed

Sandeep Bagla

placement in larger glands. He believes that radioembolization can overcome these limitations, while also delivering higher therapeutic doses with minimal off-target effects. “Our initial results have been incredibly promising,” he comments, “demonstrating both feasibility and safety in an animal model. Of note, explant analysis demonstrated no radiation injury or scarring to adjacent tissue, and validated the initial hypothesis of using radiotherapy delivered transarterially: it maximises delivery to the gland and minimises non-target radiation. Our next step would be preparing a clinical study in men with unresectable, locally advanced prostate cancer in 2021. Similar to the current paradigm for Y-90 radioembolization, treatment volumebased dosimetry would be utilised to determine radiation dosing.” However, Mouli also cautions that investigating new therapeutic options can be challenging: “The bar is very high when comparing to the standard of care,” he says. “Once demonstrating safety and feasibility preclinically, clinical translation requires collaboration between various medical specialties as well as industry support. Northwestern University is a highly collaborative enterprise, and we have a strong relationship with Boston Scientific, the sponsors of our Y-90 study. We will work together to move this therapy forward through the next phases of clinical trial testing.”

The future of embolization: “The field is advanced”

It turns out that with microcatheter technique, 3D imaging, and proper patient selection, in fact doses much higher than can be delivered externally can be delivered to organs safely, in a single setting.”

Mouli and Bagla belong to a generation of interventional radiologists enthusiastic about the potential of embolization in several guises. Mouli expands: “As interventional radiologists interested in advancing the science, we are always looking for ways to expand areas of clinical success into other organs. What 20 years of radioembolization research has shown is that the traditional dogmatic thinking of radiation dose limits no longer holds when radiotherapy is performed transarterially. It turns out that with microcatheter technique, 3D imaging, and proper patient selection, in fact doses much higher than can be delivered externally can be delivered to organs safely, in a single setting. This is now being demonstrated by our current canine model, has been used in the kidney, spleen and, soon, in the brain. The radioembolization platform is quite simple to use, and when combined with modern imaging and contemporary state-of-the-art techniques, the field is advanced. Ultimately, the patients benefit.”

Issue 79 | September 2020

UK-first innovation could save lives of dialysis patients Barts Health NHS Trust has performed a UK-first operation outside of a trial setting that could reduce mortality and risks of infection in patients with dialysis. INTERVENTIONAL radiologists at The Royal London Hospital (London, UK) have carried out the new minimally invasive arteriovenous fistula (AVF) procedure, WavelinQ EndoAVF (BD, Bard). An endovascular AVF involves fusing a connection between the artery and

Interventional radiotherapy 19 adjacent vein within the forearm using direct heat which patients can use for dialysis. This procedure is an alternative to the more invasive traditional option of open surgery. The novel EndoAVF procedure results in a closed circuit that provides adequate blood flow to the superficial veins for dialysis and blood can be withdrawn, cleaned through a dialysis machine, and returned to the body. With the EndoAVF procedure— conducted by interventional radiologists Ounali Jaffer, Rashid Akhtar, and Rajesh Sivaprakasam at The Royal London Hospital—two thin catheters are inserted into the artery and the vein through small needle punctures. Magnets help to align the devices and a connection is made between the vein and artery in the forearm without the need for open surgery, which allows clinicians to access the blood stream and gives patients a reliable long-term dialysis AV fistula. The dual magnetic catheter system is removed from the body once the connection is created and the arm heals without stitches with little or no scarring.

Ounali Jaffer, interventional radiologist at The Royal London Hospital, said: “This new treatment really enhances our techniques in treating those patients with end stage kidney disease. Avoiding a central venous catheter [CVC] is imperative and now we have another procedure available to enable timely AVF creation. “There are only a finite number of options available in creating an AVF, which is the lifeline for the patient.

Interventional radiologists at Barts Health NHS Trust, London, UK

Interventional radiotherapy “needs to be considered” as a treatment of sarcomas Brachytherapy, also called interventional radiotherapy, is a treatment of sarcomas that needs to be considered within the multidisciplinary management of such patients. So concludes a recent review paper in the Journal of Contemporary Brachytherapy, reporting the results of the INTERACTS (Interventional radiotherapy active teaching school) consensus conference on this therapy option, endorsed by the Italian Society of Radiotherapy and Clinical Oncology (AIRO).

“O

ur paper is a valuable, experts’ contribution highlighting the role of interventional oncology in soft-tissue sarcoma (STS) management,” lead author Luca Tagliaferri (Fondazione Policlinico Universitario A Gemelli IRCCS, Rome, Italy) and colleagues write. They say that further studies, utilising a large database of patients, are required to achieve a stronger level of evidence. An international board of twenty-nine multidisciplinary experts in STS management and interventional radiotherapy (IRT) was invited to a consensus conference on the state-of-the-art interventional oncological treatment and management of sarcoma during the 9th INTER-MEETING (Interventional radiotherapy multidisciplinary meeting) in Rome, Italy (19–20 October 2018). At the end of each of the thirteen lectures, the entire group of experts was invited to vote electronically. The preliminary results were presented and discussed at the end of the meeting, during a dedicated session. After the meeting, an independent coordinator was nominated, and the statement vote was repeated using an online survey. An independent expert in STS was involved in the consensus conference board. Every presentation was shared with the cohort of experts. The survey contained thirty-eight statements, organised in four sessions, one of which was the potential of multidisciplinary interventional oncology. The statements’ vote was allowed from 2 April 2019 to 5 May 2019. With participants’ permission, the names of respondents were declared during the survey to avoid double completion of the survey itself, but they

were blinded for subsequent data analysis performed by the authors. A master committee then discussed the survey results. The board defined the level of consensus according to the percentage of agreement to each statement as follow: a consensus level above 90% was defined as a full consensus, between 80% and 90% was considered as a moderate consensus, between 70% and 80% a partial consensus, and no consensus was achieved for statements with below 70% agreement.

Interventional radiotherapy “could be used with less toxicity and similar outcomes to external beam radiation therapy”

All the experts agreed with the need for a dedicated multidisciplinary team to manage STSs. However, Tagliaferri and colleagues say that, despite the data from the literature, the contribution of IRT (and generally of interventional oncology) to treat STS patients is not clearly defined. They write: “Different radiotherapy techniques, such as IRT or intraoperative radiotherapy (IORT), could be used with less toxicity and similar outcomes to external beam radiation therapy (EBRT), but they are performed in very few centres with an expertise in the field, especially in STS.” Regarding interventional oncology treatments for STS, where the available scientific evidence still places them only in a palliative/systemic disease setting, the consensus board specified that electrochemotherapy (ECT) may be recommended in a palliative setting in patients with metastases unresponsive to chemotherapy or radiotherapy (97%). In a palliative/systemic disease

By extending these options, we can maximise the use of these vessels. “The obvious added benefits are that the procedure is relatively quick and leaves no sign of a procedure, with no visible scar. These are early days, but the innovation is exciting and will hopefully benefit a number of our local population with end-stage kidney disease.”

This new treatment really enhances our techniques in treating those patients with end-stage kidney disease. Avoiding a central venous catheter is imperative.”

setting, a full consensus was also recorded on imageguided therapies for metastatic sarcoma, such as percutaneous ablation and arterial embolization, which could be used as alternatives, and/or in substitution or in association with surgery or radiotherapy in patients with solitary or oligometastatic disease (97%). With a full consensus, it was recognised that preoperative embolization of primary or metastatic STS of the extremities permit to reduce the risk of bleeding during and after the surgery for hyper-vascularised tumours (100%). The authors also report that interventional radiology can provide efficient and rapid pain relief as well as bone reconstruction, with the use of cementoplasty and percutaneous ablation/cryoablation. A considerable consensus was registered about the role of radiotherapy in general: 97% of the commission considered radiotherapy a mandatory sequential treatment to surgery in most of STS extremities (both in pre- and postoperative settings). With the same consensus level, radiotherapy was considered a “questionable” treatment in retroperitoneal STS. A moderate agreement was registered for adjuvant IRT to treat small to mid-sized (<10cm) high-grade tumours of extremities and trunk with negative surgical margins (83%). Full consensus was reached for IRT delivered to prevent surgical mutilation if EBRT would lead to major long-term sequelae, and/or administration of a lower than required dose. The statement on IRT used in combination with EBRT for close or positive margins in high-grade STSs and for positive margins in low-grade STSs was reached with 100% consensus. Eighty-three percent of the panel considered IRT more advantageous than EBRT to treat lesions of the trunk and extremity <10cm in size, and after complete surgical resection with negative margins and in histological highgrade cases. Full 100% consensus was reached regarding IRT boost for dose escalation with a benefit, as compared with postoperative EBRT boost (93%). The group fully agreed that IRT should be performed in centres of excellence, which operate within the neighbouring radiation oncology departments as a network system. IRT alone was recognised as a procedure associated with a low-risk of acute and late toxicities (93%). In particular, IRT alone was considered to be related with less toxicity (especially late) than EBRT plus IRT (93%). In specific situations, IRT should be considered as a first option (93%), the review paper authors note.

September 2020 | Issue 79

20 Interventional oncology

NCCN incorporates SIO recommendations in 2020 guidelines for neuroendocrine tumour treatment

The Society of Interventional Oncology (SIO) National Comprehensive Cancer Network (NCCN) Task Force submitted recommendations to the NCCN for the latest revision of the Neuroendocrine Tumour treatment guidelines. These have been accepted.

ACCORDING TO THE society, this is the first time interventional radiology (IR) has been called out as a separate body contributing to the guidelines (see figure to the right). The inverted “U” is the mathematical symbol for intersection; SIO describe this symbol as “a fitting designation for interventional oncology operating at the intersection of cancer therapies”. For lung neuroendocrine tumours (NETS), ablation was added for treatment of primary tumours, and liverdirected therapy added for liver-dominant metastases. An entirely new section on “Principles of LiverDirected Therapy” was added to the guidelines and referenced in the sections on treatment of metastatic gastrointestinal and pancreatic NETS. The principles cover the spectrum of embolotherapies and include thermal ablation as an option, while acknowledging the limited prospective data for ablation. Adding an entirely new section of this name was the first request made from SIO late last year. Cautions about liver-directed therapies in the setting

Interventional oncology 2.0: Soul-searching to define our identity Julius Chapiro Lynn Savic Comment & Analysis Julius Chapiro and Lynn Savic claim there is “no need for scepticism” about the recent emergence and growth of immuneoncology from an interventional oncologist’s perspective. Indeed, they write that interventional oncology (IO) will thrive in this new research environment, and say that combinations of loco-regional therapies and immunotherapies are just now being trialled that may yet transform cancer care whilst centering the skills and clinical expertise of interventional oncologists.

nterventional oncology brands itself as the fourth pillar of cancer care alongside medical, surgical, and radiation oncology. Across the board, IO is now the fastest growing subspecialty in interventional radiology (IR) and certainly understands itself as the flag bearer of our entire field. The vast majority of National Institute of Health (NIH) funding for IR research supports IO science. The presence of an interventional oncologist at interdisciplinary tumour boards in every tertiary care centre has become the new normal. In fact, the rapidly growing IO culture—enhanced by our own society, the Society of Interventional Oncology (SIO)—can be seen as an organising principle among interventional radiologists that strive to abide by Charles Dotter’s everlasting legacy calling upon us to “provide clinical care” rather than practicing as “highpriced plumbers”. Our dedication to curing cancer minimally invasively—one tumour at a time—and our involvement in patient care as clinicians rather than service providers

was reinforced and invigorated during the COVID-19 pandemic. Precisely because of this level of maturity of our profession, there is no need for scepticism or concerns in light of the recent emergence of the “other IO”, immuno-oncology. Without a doubt, novel immunotherapies transformed the way we approach cancer care. As such, five novel molecular targeted agents and their combinations have become available and US Food and Drug Administration (FDA)-approved for the use in advanced stage primary liver cancer within just three years. While some in our community are overwhelmed and anxious in light of this rapid development, fearing replacement by the “other IO” in our key domain of liver-directed cancer therapies, the overall message remains reassuring: “our IO” will thrive in this new environment. As the clinical trial data on immunotherapies in liver cancer continues to trickle in, we begin to realise that therapeutic outcomes in immunotherapy have not yet delivered upon the initial

of a Whipple were modified to include any prior biliary instrumentation. Ablation was added as an option for malignant adrenal tumours. A new section on “Principles of Imaging” was created to codify recommendations for anatomical and nuclear imaging. The SIO-authored letter, dated 15 October 2019, requested the NCCN Neuroendocrine and Adrenal Tumours panel review six specific changes to update the role of liver-directed therapies in their guidelines.

promise to make a substantial difference or even provide a cure. In fact, many in our community began to explore combinations of loco-regional and immunotherapy, and, meanwhile, numerous trials have been initiated to study this exciting new option. While we eagerly await the first results from such prospective clinical trials, we must continue to do our homework in science and education. Historically, basic and translational research has been the Achilles’ heel of IR, and this is especially true for the ethos of our professional training. The fellowship training model in IR was naturally focused on rapidly building up procedural hands-on skill in just 12 months of training by means of volume, frequently leaving no room to learn the “language of oncology”. Aware of its shortcomings, the generation before us wisely paved the way for a dedicated IR residency as the new training model. As such, we are now able to recruit trainees from a pool of medical students that have six years to make IR their professional identity, and interventional oncology their subspecialty. Therefore, and in order to succeed in this increasingly complex environment of advanced cancer care, we must substantially expand upon IO education and expect engagement in basic, translational, and clinical research from day one of training. Our interdisciplinary partners in tumour boards should sit across specialised peers with knowledge and profound understanding of tumour biology, disease staging, and clinical trial design when requesting our advice. We must therefore step up in those disciplines and offer more than just technical expertise on whether or not a tumour can be safely reached and targeted under image guidance. Formal oncologic

training, increased participation in nonprocedural patient care, shared therapeutic decision-making, advice on expected outcome, and key opinion leadership in cutting edge research and guidelines must be the new hallmarks of our identity. Consequently, we must leave behind our anxious heritage as proceduralists and no longer engage in meaningless conversations about “takeover” of our procedures by “competing” specialties. The future of cancer care lies in teamwork and it is time for us to recognise our qualitative edge and expand upon our expertise beyond a set of hands-on skills that can be easily learned by anyone with interest and access to equipment. Thus, we should define new role models in this rapidly evolving field and shift away from reverence and idolisation of procedural prowess as the final endpoint of career development. Ultimately, the central task of our generation will be to establish formal IO training as part of the IR residency curriculum, and possibly even offer a formal IO fellowship for subspecialisation. With that in mind, we will continue to strengthen our role as the fourth pillar of cancer care with content and substance to ensure a bright future of our specialty for the next generation of interventional oncologists. Julius Chapiro is an assistant professor of Radiology and Biomedical Imaging, co-director of the Yale Interventional Oncology Research Lab, Yale University School of Medicine, New Haven, USA. Lynn Savic is a diagnostic and interventional radiology resident and codirector of the Minimally Invasive Tumor Therapy Research Laboratory, Charité University Hospital, Berlin, Germany.

We must leave behind our anxious heritage as proceduralists and no longer engage in meaningless conversations about ‘takeover’ of our procedures by ‘competing’ specialties.”

September 2020 | Issue 79

22 IR and COVID-19

Interventional radiology assumes a more prominent role amid pandemic Interventional radiology is “an operational and financial hedge” for hospitals during COVID-19, Mikin Patel (University of Arizona College of Medicine, Tucson, USA) and coauthors claim in Journal of Vascular and Interventional Radiology (JVIR).

“U

nder normal circumstances, interventional radiology (IR) efficiently cares for both inpatients and outpatients,” the authors note. “In response to the COVID-19 pandemic, IR has taken a more prominent role in the hospital, accounting for an increased share of both procedural volumes and gross charges at two academic medical centres [in the USA], the first with a total of 894 beds in Tucson, Arizona, and the second with 811 beds in Chicago, Illinois. This trend countered the observed, and notably opposite, trend towards a relative decrease in contribution from other prominent procedural services (surgery, cardiac catheterisation lab, and endoscopy).” The JVIR report used aggregated departmental data from the two institutions studied to investigate procedural volume. At the start of the COVID-19 pandemic, the Centers for Medicare and Medicaid Services recommended that all elective surgeries should be cancelled or delayed during the pandemic. Therefore, at both medical centres evaluated in this study, procedural volumes across the hospital decreased yearover-year (35% and 69%, respectively) in April 2020. However, IR procedural volumes decreased by a much smaller amount (22% and 35%, respectively). Over the same time-frame, procedural volumes in surgery, cardiac catheterisation lab, and endoscopy decreased by a much larger proportion: -45%, -30%, and -40%, respectively, in the Tucson centre, and -72%, -56%, and -81%, respectively, in the Chicago hospital. In Tucson, total gross procedural charges for the hospital decreased 40% year-over-year in April 2020, but IR charges only decreased 20%. For surgery, this

decrease was 44%. Gross procedural charges in the catheterisation lab declined by 35%, and endoscopy charges were reduced by 43% in the same month. “The data above demonstrate that, while other procedural services such as surgery, cardiac catheterisation lab, and endoscopy have suffered decreased procedural volume and charges, IR has filled the void,” Patel and colleagues write in their brief research letter. “The resultant increased disparity in work performed and charges generated should be recognised by hospital administration as a source of procedural revenue that is relatively spared. Furthermore, the work performed by IR [specialists] during the pandemic likely provides value by contributing to patient discharges and length of stay metrics, however the authors acknowledge this would be difficult to quantify.” They note that the majority of IR procedures took place in the outpatient setting in 2019, while most surgery and catheterisation lab procedures were performed on inpatients (56% and 60%, respectively). As the COVID-19 pandemic led to suspension of

While other procedural services [...] have suffered decreased procedural volume and charges, IR has filled the void.”

COVID-19 has had a “significant impact” on interventional radiology training “Decreases in caseload and widespread cancellation of conferences have had significant impact on diagnostic and interventional radiology (DR/IR) training during COVID-19 restrictions,” Ahmed M Gabr (Oregon Health and Science University, Portland, USA; Tanta University, Tanta, Egypt) and colleagues reflect in Academic Radiology. “Whether remote learning can mitigate lost opportunities from in-person interactions remains uncertain. Optimising these strategies will be important for potential future restricted learning paradigms and can also be extrapolated to augment trainee education during unrestricted times.” THE STUDY INVESTIGATORS SET out to assess the immediate impact of

the COVID-19 pandemic on diagnostic and interventional radiology education,

non-essential procedures, Patel et al say that resources were diverted towards inpatient care. “Paradoxically, IR pivoted from a predominantly outpatient-based practice to a service focused on hospital inpatients, while services that were predominantly treating inpatients in 2019 decreased their role,” they relate. Speaking to Interventional News, Patel comments: “I do think that IR’s role in treating hospitalised patients will continue to grow whether or not we are under pandemic conditions. In the short term, the COVID-19 pandemic has exaggerated this trend. In the long term, I am optimistic the ‘new generation’ of interventional radiologists we have been training will push the advantages of IR therapies for patients. “Ideally, hospitals will recognise the value IR brings in terms of efficacy, quality, and efficiency for patients. From the administrative perspective, it sometimes feels as if IR gets lumped in with the rest of radiology and is treated as a service to be ‘ordered’ by other physicians. It may be time for hospitals to start treating IR more like a surgical subspecialty, recognising the need for things like clinic space, scheduling support, and dedicated coders.” “IR’s adaptation to the operational shocks of the COVID-19 pandemic was largely the result of two factors: efficiency in reconfiguring workflows and availability to treat patients,” the JVIR authors continue. “At both medical centres included in this report, IR departments promptly prepared for handling of COVID-19 patients by adding negative pressure air handling for IR suites, clearly assigning duties and personal protective equipment for staff, and establishing clear protocols on potentially aerosolising procedures requiring extra precautions. Notably, these changes took effect in IR before they were implemented in the operating rooms. [...] The flexibility and motivation to accommodate the needs of the hospital are arguably core principles of IR which appear to be common across multiple institutions. During times of stress, these strengths allow IR to serve as an operational and financial hedge for ensuring the continued health of critically ill patients and burdened health systems.”

and to propose measures to preserve and augment trainee education during future crises. They reviewed diagnostic radiology and interventional radiology procedures at a single tertiary-care teaching institution between 2015 and 2020, dividing DR up by section (body, cardiothoracic, musculoskeletal, neuroradiology, nuclear medicine, paediatrics, women’s imaging) and IR by procedural types (arterial, venous, lymphatic, core, neuro, paediatrics, dialysis, cancer embolization or ablation, non-cancer embolization, portal hypertension, and miscellaneous). In their review, they note that remote learning technologies with annotated case recording, boards-style case reviews, procedural simulation, and narrated live cases, as well as online lectures and virtual journal clubs, have increased over the last few months.

Highlight findings

DR and IR caseloads decreased

significantly in April 2020 compared to the same month in the previous five years (both p<0.0001). Case volumes were reduced in body (49.2%, p<0.01), musculoskeletal (54.2%, p<0.05), neuroradiology (39.3%, p<0.05), and women’s imaging (75.5%, p<0.05) in DR Case volumes were down in arterial (62.6%, p<0.01), neuro interventional radiology (57.6%, p<0.01) and core IR (42.6%, p<0.05). The average IR trainee caseload in April 2020 was 51.9% lower than the IR trainee caseload in April in any of the previous five years (p<0.01). Utilisation of online learning increased in April. Trainees saw significant increases in overall DR didactics (31.3%, p=0.02) and no reduction in IR didactics, all online. Twelve major national and international DR and IR meetings were cancelled or postponed between March and July.

September 2020 | Issue 79

24 Interview

Profile

Matthew Callstrom

President-elect of the Society of Interventional Oncology (SIO), Matthew Callstrom discusses his journey into cancer care, and how advances in percutaneous ablation have shaped the procedure’s integration into first-line therapy. “If we [interventional oncologists around the world] can work together to achieve common standards, we will be able to develop evidence to support interventional oncology [IO] procedures in guidelines at an earlier point in a patient’s care,” he says.

What initially drew you to interventional radiology, and then more specifically interventional oncology?

makes a good research paper, in your opinion?

The opportunity to improve the care of patients through interventional radiology and IO by offering minimally invasive treatments that reduce pain and morbidity and also improve survival continues to motivate me. I strongly believe that what we offer patients is often a significant improvement over surgery and other treatment options.

I think a good research paper is focused on advancing the care of patients with clear communication of the findings. While early experience of new applications or advances is important, we need to produce evidence that shows how IO is important for patient care. It is important to recognise that decisions at tumour boards are driven by high-quality data with an emphasis on phase II/III studies.

Who have been important mentors for you throughout your career?

Could you describe a particularly memorable case of yours?

I was fortunate to have mentors that were advancing the care of patients in the very earliest days of IO. Both Bill Charboneau and Luigi Solbiati were great role models for driving improved care of patients with new, innovative technology and supporting the advancement through scholarship. They were instrumental in promoting an international approach to sharing lessons learned and advancing the care of patients with cancer.

As president-elect of the SIO, what are your hopes for the society over the next year? The primary goal over the next year will be to work with the SIO leadership and membership to help advance the clinical evidence that demonstrates the value of IO for patient care. The SIO is focused on advancing the care of patients through supporting both investigator-initiated feasibility studies but also through pivotal clinical trials, industry partnership, and advocacy for IO. We are also committed to improving the care of patients by advancing IO through guidelines and standards.

You were very involved in the World Congress of Interventional Oncology (WCIO) 2013–2017. Could you describe the transition of WCIO to SIO: Why was this necessary, and what has SIO been able to achieve that a congress alone could not?

The WCIO was a great format for communication of the advances of IO, but it was only a meeting. The transition to a society and SIO was to build the support of education, research, and advocacy that expands the impact of the physicians and industry partners committed to IO. A good example of what SIO has accomplished is the support of teams that update the National Comprehensive Cancer Network (NCCN) guidelines on a regular basis. Another benefit of a society is the support of research efforts that advance the science of IO. If you look back at the history of radiation oncology, the formation of the Radiation Therapy Oncology Group (RTOG) was instrumental in advancing the evidence that supports the use of radiation therapy for patients with cancer. SIO is working to support IO through a similar infrastructure.

As a Section Editor of Cardiovascular and Interventional Radiology, what

I have been fortunate to be involved in the care of patients that have had improved survival due to the care that we provide in our practice. I was part of the team treating a patient that had metastatic hepatocellular carcinoma (HCC) but survived more than 10 years due to the care we provided. He had more than 10 ablation treatments involving his liver, adrenal, lung, spine, and body wall. Throughout the time that we cared for him, he continued in his medical practice and his son became a teenager. We developed a great friendship and I attended his funeral with his passing, which was difficult, but the celebration of his life at the service was a profound experience for me.

Performing procedures with standard approaches and objective outcomes will both advance patient care and elevate the standing of IR/IO in the world.” With your particular expertise and interest in percutaneous ablation, what do you think is currently the most exciting research involving this procedure?

I think we are now at the point in the use of ablation procedures where integration in first-line therapy has an important role. We have established that local control with ablation is complementary and comparable with surgery and radiation therapy for some applications. I think that in the next few years we will demonstrate that ablation procedures offer the advantage of tissue preservation and less morbidity over the course of a patient’s life with cancer. There is also promising research that ablation in combination with immune therapy may provide abscopal response for patients with metastatic disease.

How do you think the COVID-19 pandemic has influenced IO, over the short- and long term?

We experienced a continued need for the treatment of patients with cancer throughout this pandemic. We initially reduced our access in order to implement safety measures such as measuring aerosol clearance in our procedural suites and improved standards for personal protection equipment. We learned that we can safely offer cancer treatments with appropriate testing. We learned the necessity of continuing to offer treatment for patients rather than attempting to prioritise only for more acute or semi-acute patients as delayed care is a risk to patients for progression and potentially survival.

Which innovations have most influenced your career, and how? The introduction of improved ablation devices has allowed better outcomes for IO treatments. The first heat-based devices we used were underpowered, and getting a complete treatment was often difficult. Percutaneous cryoablation devices have allowed

Issue 79 | September 2020

Interview 25

the expansion of treatments that we can offer. I was involved in the use of the intraoperative liquid nitrogen systems many years ago and, although innovative, treatment of renal masses, lung tumours, and musculoskeletal tumours would not be possible. We now treat more than 500 patients a year with this technology. Hybrid rooms are also putting the best imaging methods in the hands of the proceduralists, allowing both CT and fluoroscopy imaging, where they offer the best visualisation and guidance approach.

What are the biggest challenges facing IR today?

I believe we need to work together to improve the standard performance and delivery of IO treatments. Many of the procedures that have matured and are helpful for patients are done differently in centres across the world. We have been involved in multicentre clinical trials where we have struggled to gain a common approach in the use of devices and technical performance, and the outcomes have been impacted negatively. Performing procedures with standard approaches and objective outcomes will both advance patient care and elevate the standing of IR/IO in the world. If we can work together to achieve common standards, we will be able to develop evidence to support IO procedures in guidelines at an earlier point in a patient’s care.

What are your hobbies and interests outside of medicine?

Outside of medicine, I am blessed to have a wonderful family, including my wife Brenda and my two boys, Joseph (30) and Peter (27). We also have two golden doodles (Charlie and Lucy) that are our constant companions and treated like children now that we are empty nesters. We spend as much time as we can at our lake cabin that is on the lake that Brenda and I first met and honeymooned—our family and friends often join us, and although there are 10,000 lakes in Minnesota, there is only one as far as our family is concerned. I enjoy making furniture in my wood shop even though there is usually more dust than any final product generated. I also enjoy riding a road bike—on the less travelled roads near our house and cabin, and in the basement on a trainer during the too-long winters in Minnesota.

Current appointments

Chair, Department of Radiology, Mayo Clinic, Rochester, USA President-elect, Society of Interventional Oncology (SIO), Washington, DC, USA Professor of Radiology, Mayo Clinic College of Medicine and Science, Rochester, USA Consultant, Department of Radiology, Mayo Clinic, Rochester, USA Consultant, Division of Ultrasonography, Department of

Radiology, Mayo Clinic, Rochester, USA

Memberships and society positions (selected)

Member, American Medical Association (AMA) Member, American Roentgen Ray Society Member, Radiological Society of North America (RSNA) Member, Society of Interventional Radiology (SIR) Expert Advisor, SIR

Medical education

MD, Mayo Medical School, Mayo Clinic College of Medicine, Rochester, USA Resident, Diagnostic Radiology, Mayo graduate School of Medicine, Mayo Clinic College of Medicine, Rochester, USA Fellow, Crosssectional imaging, Department of Radiology, Rochester, USA

September 2020 | Issue 79

26 Peripheral interventions

Regional anaesthesia alone is reasonable for major lower extremity amputation in high-risk patients, study finds A recent study, published online on 3 August in the European Journal of Vascular and Endovascular Surgery (EJVES), found that regional anaesthesia alone is reasonable for major lower extremity amputation (LEAMP) in high-risk patients, and may initiate a more efficacious enhanced recovery programme than general anaesthesia. FIRST AUTHOR MICHAEL R HALL, senior author Katharine McGinigle (The University of North Carolina at Chapel Hill, Chapel Hill, USA) and colleagues detail that there was no difference in outcomes between regional or general anaesthesia techniques in patients undergoing LEAMP, but add that further studies are needed to establish best practices in LEAMP procedures. Hall et al emphasise the fact that major limb amputations are psychologically stressful and subject patients to perioperative cardiovascular risk. They note that up to 90% of major LEAMP are being performed under general anaesthesia, despite the fact that regional anaesthesia is an acceptable option in most cases. The authors state that obtaining a better understanding of who would benefit from regional versus general anaesthesia could reduce complications and help to establish best evidence-based practice, and their hypothesis was that patients undergoing LEAMP with regional anaesthesia would have better postoperative outcomes than patients receiving general anaesthesia. Hall and colleagues used the Vascular Quality Initiative (VQI) lower extremity amputation module to identify patients aged 18 or over who underwent LEAMP from 2013 to 2018. They note that outcomes included 30-day incidence of major adverse cardiac events (MACE) and all-cause mortality, and used multivariate logistic regression modules to compute odds ratios (ORs) and 95% confidence intervals (CI). They analysed time to death using standard survival analysis.

Writing in EJVES, Hall et al detail that the final sample included 5,567 patients (median age: 65 years; 67% white; 65% male). They report that only 719 patients, representing 13% of the cohort, received regional anaesthesia. In addition, compared with patients undergoing general anaesthesia, patients in the regional group were older (67 vs. 65 years; p<0.001) and more likely to have diabetes (78% vs. 69%; p<0.001), endstage renal disease (26% vs. 18%; p<0.001), congestive heart failure (33% vs. 27%; p<0.01), and coronary artery disease (35% vs. 30%; p<0.01). Hall and colleagues add that the overall incidence of MACE, death, and MACE or death was 5%, 6%, and 9%, respectively. In addition, there was no statistically significant difference by anaesthesia groups for MACE (OR 0.98, 95% CI 0.69–1.39) or mortality (hazard ratio [HR] 1.03, 95% CI 0.9–1.17).

Randomised controlled trial required to address confounding

According to Hall et al, this is the largest retrospective study analysing the outcomes for LEAMP using either regional or general anaesthesia. They note that other research using the National Surgical Quality Improvement Program (NSQIP) database demonstrated similar results, namely no difference in 30-day mortality or cardiac events, but was limited to above-knee amputations only and the majority of the regional anaesthesia used was spinal anaesthesia. “The present results parallel these studies while including regional

Black patients in areas with lowest PAD rates disproportionally at higher risk for amputation

That black people in the USA face disparities in terms of healthcare outcomes is among the most topical areas of discussion in current US cultural life. Research presented at the Society for Vascular Surgery (SVS) ONLINE digital conference (20 June–2 July 2020) revealed new research confirming this discrepancy.

ata presented during Scientific Session 8 on 2 July suggested that black patients in areas with the lowest rates of peripheral arterial disease (PAD) and diabetes are at disproportionally higher risk for amputation. But areas with higher prevalence of the disorder—in addition to diabetes—have the lowest rates of amputation, suggesting that these locations are better equipped to care for these high-risk patients, say investigators behind the study from which the data came. The conclusions were delivered by presenting author Mark A Eid, a surgery resident at Dartmouth Hitchcock Medical Center, in Lebanon, USA, in a talk entitled “Racial and regional disparities in the prevalence of peripheral artery

disease and diabetes and amputation rates among Medicare patients.” Eid was part of a research team that set out to investigate patients with PAD and diabetes at increased risk for nontraumatic amputations. “The associations of race with amputation risk among patients with both PAD and diabetes is not well understood in recent national patient cohorts,” they say. Accessing data from the Centers for Medicare & Medicaid Services (CMS) from 2007–2016, Eid et al identified a 10.5 million-plus cohort of patients concurrently diagnosed with both PAD and diabetes. Patients were then followed from the time of diagnosis in order to identify major and minor amputation events, the investigators said, and stratified by race—black, white,

nerve block techniques as well as all major LEAMP in the analysis,” they comment, which they add suggests acceptable short-term outcomes for all types of regional anaesthesia. The authors recognise that physiological stress during and immediately after the major LEAMP operation may drive the postoperative outcomes regardless of anaesthetic approach and state that further study is warranted to determine whether regional anaesthesia can attenuate that stress by reducing the pain response during and after surgery. Hall et al also acknowledge that the study is observational in nature and so the results do not imply causality, but instead describe the association between anaesthesia type and outcomes. Commenting further on the study design, they concede that it made controlling for residual

These findings offer a critical insight into this highly complex, highly comorbid, and understudied population.” confounding impossible. “A randomised trial would be required to address this issue,” they remark. Hall and colleagues end by stressing the many strengths of the methods they used. “The VQI represents a ‘real-world’ data source that provides a view of current outcomes in a large population of patients undergoing elective limb amputation,” they comment, adding that these findings “offer a critical insight into this highly complex, highly comorbid, and understudied population”. The authors conclude that many patients are candidates for regional anaesthesia and this study “has shown that this method of anaesthesia is a reasonable alternative to general anaesthesia”.

and hispanic—in order to determine differences in outcomes. “We examined associations between the regional prevalence of PAD and diabetes and amputation rates, at the level of the state and the hospital referral region,” they went on. The average rate of amputation

Regardless of location or prevalence of disease, people of colour are disproportionately at higher risk for amputation. Black patients in areas with the lowest rates of PAD and diabetes are disproportionately the highest risk for amputation overall.”

between 2007 and 2016 was 25.9 amputations per 1,000 patients with PAD and diabetes, Eid et al found. Analysed by race, black patients had almost a two-fold higher rate of amputation as compared to white patients (52.2 vs. 30.7 per 1,000 patients; p<0.001), while similar rates when compared to hispanic patients (52.2 vs. 46.5 per 1,000 patients; p=0.09), the researchers revealed. “However, states with larger populations of patients with diabetes and PAD had lower rates of amputation across all races,” Eid said. “We also observed an indirect and significant association between regional prevalence of PAD and diabetes and amputation risk for both white and black patients.” Eid et al said that the implications of the study show that regions with higher prevalence of PAD and diabetes “paradoxically have lower rates of amputation, perhaps due to better infrastructure and resources.” They further concluded: “Concomitant PAD and diabetes is common among Medicare patients, yet rates vary by more than six-fold across the USA. “Regardless of location or prevalence of disease, people of colour are disproportionately at higher risk for amputation. Black patients in areas with the lowest rates of PAD and diabetes are disproportionally the highest risk for amputation overall.”

Issue 79 | September 2020

Peripheral arterial disease 27

High level of heterogeneity found in randomised PAD trial antithrombotic regimens A recent systematic review showed that randomised trials comparing different types of peripheral endovascular arterial intervention have a high level of heterogeneity in their antithrombotic regimens. It also revealed an increasing trend for use of dual antiplatelet therapy post intervention with no clear justification. AUTHORS MAHIM I QURESHI (North Bristol NHS Trust and University of Bristol, Bristol, UK) and colleagues comment that this finding demonstrates a lack of standardisation and poor reporting of antithrombotic therapy in randomised controlled trials of endovascular intervention. Writing in the July issue of the European Journal of Vascular and Endovascular Surgery (EJVES), they remark that antiplatelet therapy needs to be standardised in trials comparing endovascular technologies in order to reduce potential confounding. Exploring this potential for confounding, they remark that dual antiplatelet therapy increases the major bleeding risk, which may contribute to late mortality if regimens were continued long term. “This is especially relevant in the current climate,” they comment, highlighting that the trials included in this systematic review contributed to the late mortality results attributed to paclitaxel.

Qureshi and colleagues say that while randomised trials of new devices for peripheral arterial endovascular intervention are published regularly, the evidence for which antiplatelet and/or anticoagulant (antithrombotic) therapy to use after an intervention is lacking. The aim of this systematic review, therefore, was to examine the antithrombotic regimens in randomised trials for peripheral arterial endovascular intervention to understand choices made and trends with time or type of device. Qureshi et al sourced information from the Medline, Embase, and Cochrane Library databases. They included randomised trials involving participants with peripheral arterial disease (PAD) undergoing any endovascular arterial intervention. The investigators assessed trial methods to determine whether an antithrombotic protocol had been specified, its completeness, and the agent(s) prescribed. They classed

antithrombotic therapy protocols as periprocedural, immediate postprocedural (up to 30 days following intervention), and maintenance postprocedural (therapy continuing beyond 30 days). Qureshi and colleagues included 94 trials in the narrative synthesis. They note that study quality was low and that none of the trials justified their therapy protocol. Only 29% had complete periprocedural antithrombotic protocols, and 34% had complete post-procedural protocols.

The introduction of newer technologies for below-theknee interventions

The authors report in EJVES that antiplatelet monotherapy and unfractionated heparin were the most common regimen choices in the periprocedural setting, and dual antiplatelet therapy (55%) was most commonly utilised post procedure. They write that over time there has been an increasing tendency to use dual therapy (p<0.001), which corresponds with the introduction of newer technologies and trials focused on belowthe-knee interventions. Qureshi et al’s results show that periprocedurally, aspirin remains the most widely adopted antiplatelet monotherapy, despite randomised evidence favouring clopidogrel. They note that reasons for this were unclear, but speculate that cost may be a factor as clopidogrel has only relatively

recently come off patent. “There is the potential to reduce cardiovascular events periprocedurally by using clopidogrel in future trials,” they add. In the discussion of their findings, the authors comment on potential bias in the randomised trials included in their study. They note that even though a formal meta-analysis could not be performed, a risk of bias assessment was included as a marker of study quality. This showed a concerning amount of “unclear” bias such as detection bias and attrition bias, which can be compensated for by good trial design and follow-up.

Study limitations

Qureshi et al acknowledge that their review has some limitations. They detail, for example, that it was impossible to tell whether some trials used antiplatelet agents alone in the periprocedural phase or whether they simply made no statement on heparin/anticoagulant use. They remark: “Because of this lack of clarity, it was impossible to confidently separate antiplatelet and anticoagulant use in these trials, which means some of the periprocedural regimens may not reflect ‘real-life’ practice during procedures.” They emphasise also the strengths of their review, specifically its “allencompassing search protocol” and “robust reporting of results,” but stress the need for an independent randomised trial specifically examining antiplatelet therapy following peripheral arterial endovascular intervention.

September 2020 | Issue 79

28 Depression and PAD

PAD patients with depression had worse recovery, women twice as likely to be depressed Patients with peripheral arterial disease (PAD) and depressive symptoms experience worse recovery compared to counterparts without depressive symptoms, one year after receiving specialty care for PAD. Women especially carry a high burden as the prevalence for depressive symptoms was twice as high as compared with the prevalence in men. This is the conclusion of new research published on 12 August in the Journal of the American Heart Association (JAHA).

irst author Qurat-Ul-Ain Jelani (Yale University School of Medicine, New Haven, USA) and colleagues begin by stressing that PAD remains a significant health problem, affecting over 200 million people worldwide. “The disability associated with PAD is significant,” they write, adding that “although PAD presents itself at least as commonly in women as in men, women’s experiences of the disease burden may be worse than that of men’s, as expressed by greater functional impairment, worse health-related quality of life, and poorer outcomes after lower extremity revascularisation procedures.” Considering what is known and unknown about depressive symptoms and PAD, the authors detail that symptoms are recognised to be associated with a more dramatic annual decline in functional performance, reduced walking distance, less quality-of-life benefit after revascularisation, and an increased risk of death/major adverse cardiovascular events, coronary heart disease, and contralateral PAD events. “However, it is unclear as to what extent depressive symptoms may be associated with a worse health status recovery profile in patients with PAD, and whether women are affected differently than men,” they point out. “This is the first study to document how depressive symptoms may complicate PAD recovery even among patients receiving specialty care,” said senior study author Kim G Smolderen (Yale University School of Medicine). For one year, researchers followed 1,243 patients treated at vascular specialty clinics in the USA, the Netherlands, and Australia who were being treated for new or recurrent symptoms of PAD. Patients included in the study (average age 67, 38% women) were enrolled from the PORTRAIT (Patient-centred outcomes related to treatment practices in peripheral artery disease investigating trajectories) registry. The international registry addresses gaps in knowledge about the quality of care and health outcomes of patients with PAD, especially as seen from the patients’ perspectives. Researchers assessed depressive symptoms at the beginning of the study using the standard eight-item Patient Health Questionnaire (PHQ-8). Patients rated statements about how often they: have “little interest or pleasure in doing things;” feel “down, depressed, or hopeless;” have “trouble sleeping;” feel “tired/no energy,” have “poor appetite or overeat;” feel “bad about yourself;” or believe they are “moving or speaking so slowly that other people notice/or are so fidgety or restless that they have to move around a lot more than usual.” Disease-specific and general health status were measured at the beginning of the study and three, six, and 12 months later with standardised patient interviews. The researchers then reconstructed the one-year health

Multidisciplinary approach that includes mental health supports for patients with PAD would be “beneficial”

In the discussion of their findings, the authors emphasise the scale of the task at hand: “Despite the enormous patient and economic burden associated with both depression and PAD, we are just starting to understand the potential impact of how mental health concerns may complicate PAD treatment and outcomes. “Although it has been demonstrated in coronary artery disease that depressive symptoms are disproportionately present in women compared with men, and that these symptoms are linked with adverse clinical and health status outcomes, the association between depressive symptoms and PAD-specific health status outcomes and how this may differ by sex have not been studied in PAD.” Considering the importance of conducting the present study, Jelani highlights that a “major goal” of PAD treatment is improving patients’ health status and quality of life. She asserts, therefore, that “not recognising or treating depressive symptoms may stand in the way of realising optimal recovery”. Looking to the future, Jelani writes: “As more value-based care options are designed for patients with PAD, integrating mental health screening and treatment pathways into chronic disease management may increase the opportunity for patients to receive more holistic care, thus improving outcomes. A multidisciplinary approach that includes mental health supports for patients with PAD would be beneficial.” She adds that it is important to increase the knowledge and awareness of vascular specialists who treat patients with PAD, such that they know that women have a higher prevalence of depressive symptoms from an epidemiological standpoint. These patients could then be referred for further depression evaluation and treatment “as part of an integrated care vision that maximised patients’ outcomes”. Because the study was focused on patients treated at vascular specialty clinics, the findings may not be representative of the general PAD population who may not have access to specialty care. Researchers also acknowledged that the emphasis on depressive symptoms excludes many mental health concerns, such as anxiety or stress, and also excludes unmeasured clinical factors that could contribute to depressive symptoms.

“There is a need to explore mechanisms of this increased vulnerability in women” status trajectory by whether or not patients reported depressive symptoms when they were diagnosed with PAD. The analysis found: Men and women with depressive symptoms had worse health status at each time point, compared with patients who did not report such symptoms. More women than men had depressive symptoms, 21.1% vs. 12.9%, respectively. One in five women with a new diagnosis or worsening symptoms of PAD may have clinically relevant depressive symptoms one year after diagnosis, approximately two times higher than men. The women experienced worse health status outcomes that are partially explained by depressive symptoms.

We are just starting to understand the potential impact of how mental health concerns may complicate PAD treatment and outcomes.”

The authors summarise: “Our findings indicate that the burden of depressive symptoms in PAD is substantial, and patients affected by them, especially women, have distinctly worse PAD-specific health status after receiving PAD specialty care.” They detail that effect sizes were large and carried over at each follow-up point in the year after seeking PAD treatment. Considering potential future research in the field, Jelani et al stress that “there is a need to explore mechanisms of this increased vulnerability in women”. While these have been “extensively described” in other atherosclerotic diseases, like acute myocardial infarction, there is much that is still unknown in relation to PAD. Furthermore, the authors recognise that “the problem is not limited to women alone”. They write that among men, too, patients who are dealing with depressive symptoms have worse PAD health outcomes over time. “Depressive symptoms in older, chronic disease populations, such as PAD, should be a continuous focus of its multidisciplinary treatment so as to ensure quality PAD care and optimise outcomes”, they state. “PAD is more than treating the legs and the corresponding pain,” Smolderen said. “We need awareness for the patient as a whole in order to provide patient-centric care.”

Issue 79 | September 2020

Patient-specific computation model may improve AVF maturation rates The results of a randomised controlled trial—the Shunt simulation study—show that a new patient-specific computation model accurately calculated postoperative access flow. As flow is related to maturation, the authors argue that this model may potentially improve arteriovenous fistula (AVF) maturation rates.

uthors Niek Zonnebeld (Maastricht University, Maastricht, the Netherlands) and colleagues—on behalf of the Shunt simulation study group—add that further investigation is needed to improve the predictive power of these simulations in order to render the computational model an adjunct to surgical planning. Writing in the July edition of the European Journal of Vascular and Endovascular Surgery (EJVES), Zonnebeld et al detail that an AVF needs to mature before it becomes suitable to cannulate for haemodialysis treatment,

Peripheral trials 31 and that maturation depends on postoperative flow increase. The authors highlight that AVF maturation remains a permanent issue in vascular access surgery for haemodialysis treatment, with 20–40% of AVFs failing to mature. To address this, they developed a patient-specific computational model that predicts immediate postoperative flow, and hypothesised that providing information from this model for planning of fistula creation might reduce failure rates. Zonnebeld and colleagues conducted a multicentre, randomised controlled trial in nine Dutch hospitals, in which they recruited patients with renal failure who were referred for AVF creation. Using 1:1 randomisation, they assigned patients to the control or computer simulation group. Both groups underwent a work-up, with physical and duplex ultrasonography (DUS) examination. In the simulation group, the data from the DUS examination were used for model simulations, and—based on the immediate postoperative flow prediction—the ideal AVF configuration was recommended. Zonnebeld et al detail that the primary endpoint was AVF maturation defined as an AVF flow ≥500ml/min and a vein diameter of ≥4mm six weeks postoperatively. The secondary endpoint was model performance (i.e. comparisons between measured and predicted flows, and (multivariable) regression analysis for maturation probability with accompanying area under the receiver operator characteristic curve. A total of 236 patients were randomly

assigned (116 in the control and 120 in the simulation group), of whom 205 (100 and 105, respectively) were analysed for the primary endpoint. The authors report in EJVES that there was no difference in failure to mature rates between the groups (29% and 32%, respectively). Immediate postoperative flow prediction had an OR of 1.15 (1.06–1.26; p<0.001) per 100ml/min for maturation, and the accompanying operator characteristic curve was 0.67 (0.59–0.75). Zonnebeld and colleagues recognise that the study has several limitations, including the fact that the primary endpoint was not a clinical one; it does not give any information on the functionality/usability of the AVF. However, they stress that it is an objective measure, and when patients reach the criteria of ≥500ml/min and a vein diameter of 4mm, as defined in this study, there is a 95% likelihood that the AVF will become functional. Furthermore, to assess the vascular access functionality, the included patients should have initiated dialysis treatment. However, it remains very difficult to predict which and when a predialysis patient will progress to dialysis dependency and start haemodialysis. In the latter group of patients clinical AVF functionality cannot be determined. Despite these limitations, the authors highlight the generalisable nature of their results, due to the fact that most of the (pre-)haemodialysis patients in need of an AVF were eligible for inclusion, and that the study was designed in such a way that it could be implemented easily in

Intermittent claudication: EffPac trial confirms benefit and safety of paclitaxel-coated balloon catheter In the EffPac trial, designed to compare a drug-coated and an uncoated balloon in the treatment of vascular occlusion in the femoropopliteal region, the drug-coated device proved to be superior. Additionally, the complete review of the study cohort two years after the intervention showed no increased mortality with the drug-coated balloon. IN COOPERATION WITH THE Center for Clinical Studies, radiologists at Jena University Hospital, Jena, Germany, initiated an investigation to evaluate the efficiency of the Luminor paclitaxel drug-coated balloon catheter (iVascular) versus an uncoated balloon. The success of the treatment was measured by the patient’s ability to walk and by ultrasound examinations of the vascular permeability in two follow-up examinations. This prospective, multicentre, randomised controlled trial enrolled a total of 171 participants at 11 centres throughout Germany. Principal investigator Ulf Teichgräber (Jena University Hospital) summarises the result: “Compared to the control group, in the group treated with drugcoated balloon catheters, there was better vascular permeability and less tissue formation at the former constriction two years after the procedure.” On behalf of the Federal Institute for Drugs and Medical Devices (BfArM) in Germany, the study authors re-checked the complete cohort with respect to morbidity and mortality. The reason for this was a meta-analysis of angioplasty studies published last year that warned of long-term increased mortality associated

with paclitaxel-coated devices. This warning triggered discussions amongst experts, since subsequent analyses of patient-level data could not confirm the increased long-term risk. According to a Jena University Hospital press release, a possible source of error in determining mortality rates is not considering patients who have not completed the entire follow-up programme. “Within the trials considered in the meta-analysis, these patients counted up to a quarter of the subjects. Their data

The mortality risk by drug-coated balloons turned out to be even lower than that shown in the original two-year results recently published.”

daily practice. In addition, DUS protocols were standardised to comply with the model’s demands. Usually Dutch hospitals have well-equipped vascular laboratories with trained technicians who routinely perform preoperative DUS examination for AVF surgery. Zonnebeld et al write that the multicentre design of the present study is a “major strength,” as it shows that the model can be implemented in other clinics. In addition, they note that selection of dialysis facilities for the multicentre study ensured a representative sample of the Dutch dialysis population, comparable with other European populations and studies. Compared with North American studies, however, they recognise that there is a considerably lower percentage of blacks included. The authors summarise that simulating patient-specific immediate postoperative flows is an “innovative approach” to improve AVF maturation. “Since AVF maturation does not depend on blood flow enhancement through the anastomosed vessels exclusively, the predictive power of a single model was found to be insufficient to support clinical decision-making,” they write. Looking to the future, the Shunt simulation study group speculate that incorporating the flow predictions in a hybrid model, in which other relevant but non-physical parameters or factors can be incorporated, might be beneficial, especially when the accuracy of the flow predictions in fistulae that have failed to mature is also improved.

are not included in the study result as if they had not participated at all. However, for mortality assessment, they have to be included. This happened for the first time in the EffPac trial: in the subsequent review, 167 patients were recorded, which represents almost the entire study cohort, thus preventing a misjudgement in comparing the groups,” the press release reads. The review yielded no difference in the survival after two years between the groups treated with an uncoated balloon or with a paclitaxel-coated balloon. Teichgräber comments: “The mortality risk by drug-coated balloons turned out to be even lower than that shown in the original two-year results recently published. We could confirm angioplasty with paclitaxel-coated balloons to be a long-term successful and safe treatment option for intermittent claudication.”

September 2020 | Issue 79

32 Neurointerventions

News from SNIS: New study finds racial disparities in acute stroke thrombectomy management A new study has found several racial disparities after mechanical thrombectomy for stroke with respect to post-procedure management and outcomes. Vineeth Thirunavu of Northwestern University Feinberg School of Medicine, Chicago, USA, presented the data at the Society of NeuroInterventional Surgery’s (SNIS) 17th Annual Meeting (4–7 August, virtual meeting), which detailed key findings from the Neurovascular Quality Initiative Quality Outcomes Database (NVQI-QOD) registry. SPECIFICALLY, THIRUNAVU EXPLAINED that minority groups, including Hispanics, Asians, and African Americans, exhibited worse immediate postprocedural outcomes and a greater length of in-hospital and intensive care unit (ICU) stays. “Race seems to be implicated in the length of treatment for acute ischaemic stroke,” he told the online audience. However, he said that the registry yielded an “interesting finding” in that in-hospital mortality for African Americans appears to be lower compared to their Caucasian counterparts. “This finding does not necessarily correlate with the findings that you would expect with longer length of stay and more ICU days.” Discussing this finding further, Thirunavu added that in terms of outcome variables—modified Rankin scale

(mRS) score and 90-day mRS—no difference in the rate of favourable outcome between races was observed when excluding mRS scores of six. Speculating as to why in-hospital mortality for African Americans was significantly lower, he said: “It could be a cultural thing, or not staying on the support of care, but we really have to do more research to see at what level these disparities are occurring; is a patient level, a genetic level, or are healthcare providers treating patients differently?” Discussing what the led the team to initially investigate racial disparities, Thirunavu said that since endovascular therapy has become the standard of care for stroke, research has focused on the disproportionate burden of stroke and cerebrovascular disease on African Americans. “Some studies have also looked into other minority groups […] but that research has focused on differences in the utilisation and access to mechanical thrombectomy; not a lot of research carried out has been on outcomes after mechanical thrombectomy, in terms of mRS scores or National Institutes of Health Stroke Scale [NIHSS] scores,” he added. Therefore, according to Thirunavu, the current study utilised real-world evidence from the NVQI-QOD registry, enabling the team to study racial disparities in a large group of patients throughout the USA. In total, he reported that 3,261 patients from 23 US centres across 17 states, over a five-year time period (January 2015– March 2020), were included. He pointed to a slide displaying the population breakdown by race. It showed that 2,484 patients were Caucasian, 563 African American, 109 Hispanic, and 105 Asian. He admitted that there might be a slight underrepresentation of Hispanics in the cohort. “We used a robust set of outcome variables; we were able to look up days to follow-up, and in-hospital mortality. In addition to the initial statistical analysis, we looked at regression models which controlled for demographics, comorbidities, intravenous tPA [tissue plasminogen activator] thrombolysis and pre-stroke functional measures,” Thirunavu explained. However, he pointed to a particular caveat with the outcome variables, acknowledging that the registry contains some limited data. “Only 33% of patients that

Race seems to be implicated in the length of treatment for acute ischaemic stroke. […] We also need to look into the relationship between sex and race, and think about how we can improve mRS data collection for registries.” are alive at 90 days had mRS scores reported; two-thirds of the data are still up for grabs, and we do not know how those individuals faired,” he told viewers, and further emphasised that mRS, especially at 90-days, is an important outcome variable after mechanical thrombectomy. Thirunavu told the SNIS audience that time-to-event analyses need to be carried out. He noted that the NVQI registry has some data on this. “We also need to look into the relationship between sex and race, and think about how we can improve mRS data collection for registries, and have better outcome variables,” he concluded.

51% of neurointerventional non-physician staff report burnout A survey of US neurointerventional non-physician procedural staff demonstrates a self-reported burnout prevalence of 51%. According to Patrick Brown of Wake Forest Baptist University (Winston-Salem, USA), who presented the data at the Society of NeuroInterventional Surgery’s (SNIS) 17th Annual Meeting (4–7 August; virtual meeting), this figure was driven more by interaction with leadership and physician staff than by thrombectomy procedural volume and stroke call. He also highlighted that attrition among neurointerventionalist non-physician procedural staff is high.

iven the “heavy toll” that burnout takes on healthcare providers, Brown told the SNIS audience that the team sought to assess the prevalence and risk factors for burnout among neurointerventional non-physician procedural staff, such as nurses and technologists. Research investigating burnout within

this cohort is important, he conveyed, due to the increasing demand of thrombectomy. The team sent out a 41-question online survey containing questions including the Maslach Burnout Inventory-Human Services Survey for Medical Personnel. According to Brown, it was distributed to neurointerventional nurses as

well as radiology technologists at 20 endovascular capable stroke centres around the USA. Discussing the results, Brown said that the team received 244 responses; a response rate of 64%. Median (inter-quartile) composite scores for emotional exhaustion were 25 (15–35), depersonalisation 2–11, and personal accomplishment 39 (35–43). In total, 51% of respondents met the established criteria for burnout. However, Brown explained that there was no significant relationship between hospital

thrombectomy volume, call frequency, call cases covered, or length of commute. Regarding the multiple logistic regression analysis, feeling underappreciated by hospital leadership and working with difficult or unpleasant physicians were “strongly associated” with burnout. Moreover, at participating centres, nurse and technologist attrition was 25% over the last year, while— according to Brown—the analysis also indicated that over 50% of respondents had strongly considered leaving their position over the last two years.

September 2020 | Issue 79

34 Stroke

The stroke trials you need to know about, as presented at SNIS 2020

From acute interventions to endovascular therapy indication expansion, Sunil Sheth from McGovern Medical School at UTHealth, Houston, USA, kick-started the Society of NeuroInterventional Surgery’s (SNIS) annual meeting (4–7 August) by outlining an array of recently completed, and ongoing stroke trials.

“I

f I do not include your favourite trial, please forgive me,” he said. “Our goal today is to cover the full range of acute ischaemic stroke studies. From start to finish I will try to have representation from trials around the globe.” He explained to the audience that he has organised the trials by the segment of care; trials pertaining to prevention of stroke, systems of care, acute interventions, endovascular therapy indication expansion, and stroke recovery trials.

Stroke systems of care

Pointing to trials pertaining to systems of care, he discussed the RACECAT trial—a prehospital stroke trial. “In Barcelona, Marc Ribo’s group is trying to answer the question: Which is the better routing strategy in the prehospital environment? Is it going from emergency medical services (EMS) directly to a primary stroke centre, or from EMS—bypassing the primary stroke centre—and going directly to a comprehensive stroke centre? “The patients are being pre-screened and have to have some suspicion of LVO with a Rapid Arterial Occlusion Evaluation (RACE) score >4, and the trial is being conducted in areas where the local hospital cannot perform thrombectomy. This is a trial that is very close to being completed, and I am looking forward to those results.” The TRIAGE (Treatment strategy in acute ischemic large vessel stroke: prioritise thrombolysis or endovascular treatment) trial is similar, he said. In Denmark, patients are being randomised in the prehospital setting—either going directly to a primary stroke centre for IV tissue plasminogen activator (tPA) and then to a comprehensive stroke centre, versus going directly to the latter. The last trial regarding optimising stroke systems of care he discussed was the BEST-MSU (Benefits of stroke treatment delivered using a mobile stroke unit) trial. Here, patients were randomised to either getting mobile stroke unit care versus standard EMS care, and had to be eligible for IV tPA. “They enrolled their last patient last week, so they are now completing their follow up and we should be hearing from them soon.”

Acute Interventions: Drugs

The next set of trials are interventional trials that involve medical therapies, Sheth told the SNIS online audience. “The first is MOST (Multi-arm optimisation of stroke thrombolysis); a trial randomising patients that get intravenous (IV) tPA to receive either argatroban, eptifibatide, or placebo,” he said, adding that patients receive the study drug within one hour of IV tPA, and thrombectomy is allowed in these patients. In addition, the TIMELESS (Tenecteplase in stroke patients between 4.5 and 24 hours) trial is randomising patients to either a single bolus dose of tenecteplase or placebo. Sheth noted that these patients are not IV tPA eligible, randomised between 4.5 to 24 hours of stroke onset. However, they have to have a large vessel occlusion (LVO), and their imaging criteria must include a mismatch on CT perfusion and MRI. Like the MOST trial, TIMELESS is currently enrolling. Sheth next introduced the first of several MR CLEAN follow-up trials. “MR CLEAN MED, a medical trial with a 2×2 factorial trial, includes patients with

thrombectomy that was planned (with an LVO), getting randomised either to receive 300mg aspirin, or not, and/or a heparin bolus dose drip, or not. This is an open label study, so these are patients that are getting thrombectomy, with the drugs infused at the time of groin puncture, or right after IV tPA is completed.” He added that the study started in 2018, and is a third of the way through enrolment. In terms of the MR CLEAN NO IV trial, Sheth told viewers that this explores the question of whether or not IV tPA is useful when patients are also getting thrombectomy. Key criteria include that patients must be IV tPA eligible (within 4.5 hours), and have to have an LVO. “One of the unique aspects of this trial, like the original MR CLEAN trial, is that delayed consent is allowed, so you can screen and enroll, and randomise patients without consent upfront. Because of this, they have been enrolling very well; faster than expected, so the trial should be completed very soon,” Sheth highlighted. Another trial looking to answer the same question

In terms of the endovascular therapy indication expansion trials, we [...] have a Chinese endovascular trial (BAOCHE), investigating whether or not basilar artery occlusion patients benefit from thrombectomy.” is the SWIFT DIRECT (Bridging thrombolysis versus direct mechanical thrombectomy in acute ischaemic stroke) trial, which is randomising patients to thrombectomy (with Solitaire; Medtronic) with or without IV tPA. Again, these are IV tPA eligible patients with LVO, and an Alberta Stroke Program Early CT score (APECTS) ≥4. The estimated completion of this trial is 2022.

Endovascular therapy indication expansion

Sheth displayed the first set of four trials to the SNIS viewers, describing them as the “so-called large core trials”, which are exploring whether thrombectomy is helpful in patients that are presenting with an established moderate to large stroke. TESLA (Thrombectomy for emergent salvage of large anterior circulation ischaemic stroke) is testing thrombectomy versus medical management for patients with large cores (which is defined here as an ASPECTS 2–5 in patients up to 24 hours of stroke onset. In this study, internal carotid artery (ICA) or M1 occlusions are allowed, but tandem occlusions are being avoided. Currently over 40/300 patients have been enrolled. “Then we have the TENSION trial out of Europe, which again explores thrombectomy versus medical management for large core,” Sheth explains. However,

while the study has similar inclusion criteria to TESLA, large core is defined as ASPECTS 3–5. Sheth said it has a larger sample size (n=655), with around 93 patients enrolled so far. Regarding the remaining large core trials, Sheth said the LASTE (Large stroke therapy evaluation–ASPECTS 0–5) trial, part of the IN EXTREMIS cohort, defines large core as ASPECTS 0–5, up to 6.5 hours after stroke onset, and also includes ICA or M1 occlusions, while the SELECT 2 trial is similar, but a “major difference” is that CT perfusion is required in these patients. “At the opposite end of the spectrum, we have the low National Institutes of Health Stroke Scale [NIHSS] studies,” Sheth said. First, he introduced the ENDOLOW (Endovascular therapy for low NIHSS ischaemic strokes) trial, which examines thrombectomy (with Embotrap; Cerenovus) versus medical management (with possible thrombectomy rescue) in patients with internal carotid artery (ICA) or M1 occlusions that have an NIHSS score 0–5. “Imaging criteria for this trial is ASPECTS ≥6,” Sheth added, “and there are also some CT perfusion and MRI criteria as well. The trial is currently enrolling, estimated to be completed by next year.” According to Sheth, the MOSTE (Minor stroke therapy evaluation—NIHSS 0–5) trial is also looking into thrombectomy versus medical management, with possible thrombectomy rescue within 24 hours, with ASPECTS screening as an inclusion requirement. “In terms of the EVT indication expansion trials, we also have a Chinese endovascular trial (BAOCHE), investigating whether or not basilar artery occlusion patients benefit from thrombectomy, which is still an outstanding question, at least from a clinical trial point of view,” he told the SNIS audience. Lastly, he explained that the MR CLEAN LATE trial is a late time window trial. He proposed that it is different from DAWN and DEFUSE 3 as CT perfusion is not required. Instead, the imaging requirement is computed tomography angiography collateral grading.

Acute interventions: Devices

Next, Sheth alluded to a number of studies looking at devices, which are mostly industry-sponsored. The EXCELLENT trial, sponsored by Cerenovus, is studying the Embotrap through a prospective registry. The COMPLETE study is looking at the Penumbra aspiration catheters and the 3D separator. Sheth said this trial is now complete, and the results should be out soon. PROST by Phenox is looking at their Preset device versus the Solitaire (Medtronic) device. “This is not a registry,” Sheth explained, “but a randomised trial between two treatment approaches.” The TIGER trial that Rapid Medical has recently completed investigated their Tigertriever as a prospective study. According to Sheth, Imperative Care’s trial is coming soon, which seeks to compare their Zoom aspiration catheters to Solitaire or Trevo (Stryker). Finally, he said the INSIGHT study by Penumbra is a registry for thrombus collection in thrombectomy and intracerebral haemorrhage evacuation. “But this is not a device trial, per se,” he added.

Stroke recovery trials

“There is a whole suite of recovery trials, but I am going to focus on two,” Sheth told the audience. PISCES III (Investigation of neural stem cells in ischaemic stroke) involves testing a stereotactic injection of stem cells into a region adjacent to the infarct, versus sham surgery. Key criteria for this include some residual arm function, stroke within six to 24 months, and sufficient language function. Enrolment for PISCES III is complete. The concluding trial of his talk referred to one examining transcranial direct current stimulation (tDCS) and task-specific practice for post-stroke neglect. The design involves comparing bilateral parietal tDCS versus bilateral primary motor cortex tDCS, versus sham plus task-specific practice. In terms of its status, Sheth said it is still enrolling.

Issue 79 | September 2020

CIRSE updates 37

The first virtual CIRSE: What you need to know Ahead of the first ever virtual meeting of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE), Thomas Kröncke, chairperson of the CIRSE 2020 scientific programme committee, speaks to Interventional News about the programme highlights, and the logistics of how an online congress will function. He encourages readers to participate.

Due to the COVID-19 pandemic, this year’s annual CIRSE meeting will take place online. How will the programme look? Which sessions will stay the same as they were, and which will change?

As the CIRSE 2020 congress will be online this year, some of the presentation formats will be adapted, but the content of the congress will remain almost completely as originally planned. All authors of accepted abstracts and all invited speakers will have the opportunity to present their posters and lectures to a worldwide audience. Part of the on-demand programme will be available online from 1 September, in order to give the interventional community the opportunity to prepare for the large virtual get-together during the four days of the congress. During the CIRSE 2020 Summit from 12–15 September, ten hours of live programming will be offered throughout three channels—the Dotter, Rösche, and Grüntzig auditoriums. On 15 and 16 September, a fourth channel will be added: the IDEAS auditorium. The preliminary programme

and registration are online at www.cirse. org. During the summit, just as at a physical congress, the focus will be on interactivity and the opportunity to exchange views and ideas. There will be a number of interactive formats for this, such as case-based discussions, expert round tables, workshops, and much more. The participants will always have the opportunity to ask the lecturers questions and to participate in the discussion.

What is the focus for the CIRSE 2020 programme?

A clear focus of this year’s meeting is on the presentation of the latest data and the push for evidence-based practice in interventional radiology. For example, the results of the FEMME study (see pages 1–6) will be presented, in which the quality of life of women after embolization versus myomectomy was examined. The presentation of the first results from two registry studies on transarterial radio- and chemoembolization carried out by CIRSE will also be very exciting. Regarding peripheral endovascular interventions, peripheral arterial disease

(PAD) Day and the First@CIRSE session on Saturday 12 September will certainly be a highlight. Another important programme focus of the CIRSE Summit is new therapeutic approaches, such as the radiofrequencybased creation of arteriovenous fistulas or fluoroscopy-free 3D imaging.

format, CIRSE deliberately tackles the necessary discussion about a stronger female representation in leadership roles in intervention radiology.

Are there other programme highlights?

Of course, we were disappointed that the physical meeting in Munich, Germany, would not be possible this year. But we soon realised that a virtual congress also offers many opportunities. We can reach a much wider audience online. Many doctors who would not have had the opportunity to travel to Munich will now be able to take part in the CIRSE 2020 Summit. We are currently working tirelessly to create a virtual format that will further increase interactivity in the sessions. In addition to the opportunities for interaction with the speakers, there will also be break-out rooms where discussions can be continued on a smaller scale. Our team in Vienna, Austria, has evaluated the best providers and is currently creating a platform through which the meetings, industry exhibition, and communication between conference participants will be ideally served.

As mentioned, on the first day of the congress we will have a strong focus on peripheral arterial disease in a special PAD track. There will be a session scrutinising the latest study results, as well as an innovation forum in which new therapeutic approaches will be presented and discussed. On the last two days of the congress the Interdisciplinary Endovascular Aortic Symposium—IDEAS—will again take place. This important format extremely successfully aims at all specialists who deal with the endovascular care of aortic pathologies. In contrast to many other meetings, IDEAS offers a truly interdisciplinary platform through which the pros and cons of all therapeutic approaches are presented and discussed based on evidence. Another session I would like to highlight is “Women in IR”. With this

We are working tirelessly to create a virtual format that will increase interactivity.”

CIRSE publishes updated guidelines for the provision of sedation and analgesia as demand rises in IR procedures With a progressive increase in therapeutic interventions requiring the provision of sedation and analgesia (PSA), non-anaesthesiologist personnel have become more involved in performing PSA within the interventional radiology (IR) environment. Against this backdrop, the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) have released an updated standards of practice document, which provides best practices for the safe administration of PSA for IR procedures in adults. “THE DOCUMENT IS AIMED AT HEALTH professionals involved in the provision of sedation and analgesia during interventional radiology procedures,” the authors state in the abstract. “The document has been developed by a writing group consisting of physicians with internationally recognised expertise in interventional radiology and analgesia and sedation.” The authors define sedation as “a progressive druginduced condition whereby a drop in consciousness is induced to allow the patient to tolerate an uncomfortable and/or painful interventional procedure”. They write that the process is a continuum from light sedation to deep general anaesthesia, with the latter levels of sedation requiring the advanced airway management and cardiac monitoring by a trained anaesthesiologist. Contextualising the need for these updated guidelines, lead author Stefano Romagnoli (University of Florence, Florence, Italy) and colleagues write: “Multiple factors, such as the increased co-morbidities of patients

referred to IR, cost containment, increasing numbers and complexity of IR procedures along with higher expectations among patients, have greatly increased the demand for sedation facilities. With the shortage of anaesthesiologists, scientific societies have promoted the use of rapid-acting analgesic and/or hypnotic-sedative drugs by fully trained non-anaesthesiologists to prevent and manage potentially life-threatening adverse events.” They conclude that, in order to ensure PSA is delivered safely, “it is vital that the PSA team undergoes specific training in drug administration, patient monitoring and airway management, as well as cardiovascular system support. The anaesthesia team should be available to coordinate and supervise the PSA team activities and training, to ensure the highest levels of safety. When deeper levels of sedation are required, i.e. level 3–4, anaesthetists must be involved, ideally those with a specific interest in IR.” The authors have broken up their guidelines document

What are the biggest challenges in transforming a physical congress into a virtual one?

When will the first content be available?

The scientific programme for the CIRSE 2020 Summit is already available at www.cirse.org. The first presentations are expected to be available on the congress portal in early September. In order to stay up-to-date, I invite all those interested to sign up for the CIRSE e-newsletter and to follow our channels on Facebook, Twitter and LinkedIn.

into different areas of practice: pre-procedural patient assessment and planning; monitoring, patient care, and equipment; common analgesic and sedative agents; reversal agents; and complications.

Selected recommendations

The most appropriate level of sedation should be planned prior to the procedure; Accurate evaluation and documentation of patients before the IR procedure (ideally within 30 days) is important to limit the risk of adverse events; Standard laboratory tests should be performed, and vital parameters should be documented; Patients should be positioned in such a way as to prevent pressure and positional injuries; Appropriate peripheral vascular access should be placed and maintained in position until discharge; Appropriate monitoring should be undertaken; The person who delivers the PSA must be exclusively dedicated to this task during the procedure, and cannot be simultaneously involved in the IR activity; As well as standard instrument monitoring, the level of consciousness should be assessed frequently; Basic and advanced airway equipment should be available with a full range of sizes; A pharmacologic strategy should be planned before the procedure starts; Each drug should be administered individually in a step-by-step fashion; Though rarely needed, a protocol for correct use of reversal agents should be available; Flow charts should be readily available/ on hand to guide the management of potential complications.

AORTIC VIENNA

8â&#x20AC;&#x201C;11 SEPTEMBER 2020 We would like to invite all specialists treating patients with aortic disease to attend the inaugural CX Aortic Vienna meeting, which will be livestreamed 8â&#x20AC;&#x201C;11 September 2020 to an international, online audience, and will include registrant participation, interaction, and polling.

Registration open

www.cxaortic.com

Issue 79 | September 2020

CX Aortic Vienna 39

Inaugural CX Aortic Vienna to take place online

All about the aorta

Roger Greenhalgh (London, UK), the anchor chairman, explains the evolution

Aortic Vienna will showcase HTDI open and endovascular reconstruction of the aortic arch featuring recorded cases.

A comprehensive meeting on aortic therapies

of aortic management, contextualising the need for an aortic-specific educational meeting: “What I would like to know is the pathology behind any problems with the aorta. This might be very different: for example, with the ascending aorta, with the arch of the aorta, the great vessels to the brain and risk of stroke, the descending aorta—four different pathologies there, atherosclerosis, dissection, transection, and ulceration. How do you diagnose those, how do you

Roberto Chiesa (Milan, Italy) will be specially filming open and endovascular technical procedures of how to best manage the diseases of the arch of the aorta, considering whether to intervene or not based on the underlying pathology. Chiesa runs an ace team in an academic hospital that relies on both open and endovascular expertise. He will outline the importance of a forwardthinking, non-biased approach and running daily multidisciplinary meetings in the patient interest to decide which, if

Afshin Assadian (Vienna, Austria), the current president of the ÖGG, describes CX Aortic Vienna as a “comprehensive meeting on aortic therapies” taking in contributions from speakers covering a wide range of specialties. The meeting is inspired by the historic Austrian capital city Vienna, “the pulsating heart of Europe”, but Assadian explains that the 2020 edition of the conference will be “more of a web-based event”, reflecting current circumstances. He comments: “We would invite all specialties involved in the understanding, development and progression of therapy of aortic pathologies.” The ÖGG and the SGG will livestream presentations with audience participation

image those, how do you know which is the best way to treat them in the first place? “We still live in an era where it is possible for patients to be referred to one hospital and have an open operation for the aorta, and to another hospital and have an endovascular approach. It should not be right for it to depend upon which hospital or specialist you get sent to, whether a patient should have

any, is the best treatment. Leading the discussion on aortic arch reconstruction, Chiesa will look at this “borderline territory” between cardiothoracic and vascular surgery and how treatment of such diseases requires advanced skills and cooperation between specialties. Delving into the specifics of what delegates can expect from the inaugural meeting, Chiesa highlights that CX

and discussion. Alexander Zimmermann (Zürich, Switzerland) comments that this virtual format will enable widespread participation, enabling all colleagues interested in vascular medicine “to participate and actively contribute to this event” easily, wherever they are in the world. “You can be sure that the scientific level will be amazing and the level of discussion hard to find elsewhere,” he adds.

The inaugural CX Aortic Vienna meeting will be livestreamed 8–11 September 2020 to an international, online audience, and will include registrant participation, interaction, and polling. he programme will focus on all matters aortic—from the aortic valve to the iliac arteries. All known pathologies will be included, and imaging, diagnosis and therapeutic options—open, endovascular, hybrid and no intervention—will be applied systematically to the length of the entire aorta, all the while keeping the patient front and centre. On each of the four days, the programme will cover abdominal and thoracic topics. CX Aortic Vienna 2020 is brought to you with the participation of the Austrian Society of Vascular Surgery (ÖGG), the Italian Society of Vascular and Endovascular Surgery (SICVE), the Swiss Society for Vascular Surgery (SGG), and Aortic Surgery “HOW TO DO IT” (HTDI). There will be dedicated discussion around open and endovascular choices to treat abdominal aortic aneurysm with a focus on sac size and EVAR follow-up, ultrasound versus CT surveillance after EVAR, current research into the best imaging modalities for EVAR imaging, and juxtarenal issues with challenging abdominal aneurysm neck. In the abdominal aortic section, there is an enduring fascination with the importance of diagnostic imaging modalities, as well as how to maintain endovascular aortic repair (EVAR) results, or instead turn to open repair. There is also a separate session on pathologies of the iliac vessels within the pelvis. In the juxtarenal section, the programme will explore methods to overcome the challenging aortic neck, using all manner of open and endovascular means. In the thoracic aorta, there will be sections dedicated entirely to the aortic arch, and every aspect of dissecting aortic aneurysm, especially with regard to the timing of intervention. All treatment approaches will be considered and comparisons of open and endovascular methods made in a stepwise, methodical manner. In the thoracoabdominal section, there remains obvious interest in spinal cord ischaemia and how to reduce the risk of this, with or without cerebrospinal fluid drainage. In an important collaboration, the ÖGG will be joined by the SGG in the creation of a combined livestreamed programme. The SICVE will also have a livestreamed programme and HTDI will show Arch Techniques & Technologies.

endovascular or open. The patient should have the right treatment [speaker’s emphasis]. There should be discussions in centres on whether an open or an endovascular approach is best, it should not be a territorial matter. Let us encourage every patient to be considered with all options, and have an open mind about open surgery and endovascular.”

A focus on decision-making in the patient’s interest

Issue 79 | September 2020

Market watch 41

Clinical News PRIZER, new multicentre PAD study, launches

A new post-market study investigating the effectiveness of the Renzan peripheral stent system (Terumo) in patients with peripheral arterial disease (PAD) has been initiated. The PRIZER (Prospective, multicentre post-market, single-arm study, to confirm the performance of the Renzan peripheral stent system in treating subjects with superficial femoral and/or popliteal artery disease) study plans to enrol 135 patients, in approximately 10 European centres in five countries. Patients will be stratified into two groups: 90 patients with arterial disease in both the femoral and popliteal segments, and 45 patients with isolated popliteal artery disease. The Renzan peripheral stent system consists of a self-expanding nitinol stent pre-mounted on the distal portion of a rapid exchange (RX) delivery catheter, constructed from two layers of tubular braided nitinol wire mesh. As well as aiming to confirm the safety and efficacy of the Renzan peripheral stent system in treating patients with superficial femoral and/ or popliteal artery disease, the PRIZER study aims to assess the primary patency of the artery evaluated at 12 months, compared to clinical results coming from other clinical trials using similar metallic scaffolds. “My enthusiasm about the dual layer Roadsaver stent in the carotid field can be investigated in this way in the even more challenging infra-inguinal area”, comments Koen Deloose, head of the department of Vascular Surgery at AZ Sint Blasius Dendermonde Hospital in Dendermonde, Belgium, and principal investigator of the PRIZER study. “In current times, where drugeluting technology is only reserved for high risk patients and where the need for scaffolding post drug-coated balloon treatment is high, a lot of interventionalists are really looking for a ‘daily practice’ modern scaffold that is extremely flexible, well balanced in chronic outward force and radial resistive force, and easy to implant accurately. The new 018”-compatible nitinol braided Renzan stent with dual layer technology over the full length showed in some proof of concept cases to respond extremely well to all my expectations. The PRIZER study offers us the possibility to further investigate the safety and efficacy of the Renzan peripheral stent system for treatment of superficial femoral and/or popliteal artery disease in 135 patients”, Deloose continues. “We are very proud to contribute to our commitment to physicians and their patients and drive innovation in the field of peripheral artery disease”, says Jim Rushworth, chief commercial officer, Terumo Global. “With this clinical trial,

we explore initiatives to increase our footprint in peripheral interventions.” “This new technology ensures a great flexibility, conformability to the vessel, and fracture resistance”, comments Christophe Giot, chief medical officer, Terumo Europe. “The PRIZER study aims to provide scientific evidence for RENZAN stent in patients suffering from peripheral arterial disease.” Peripheral arterial disease affects more than 200 million people worldwide PAD is a progressive disorder caused by atherosclerotic changes in the blood vessel wall, which results in stenosis or occlusion of the arteries outside the heart and brain. The pathology affects more than 200 million people worldwide. In the last decade, the number of PAD-affected individuals increased by 13% in high- and by 29% in low-income countries. The PAD prevalence increases with age, affecting over 20% of octogenarians. Lower extremity PAD is its most common subset. PAD is associated with high morbidity and both cardiovascular and all-cause mortality rates. The pathology causes major personal, medical, and socio-economic burden, increasingly becoming a global healthcare concern.

First sirolimus DEB patient enrolled in Japanese SELUTION SLR study

MedAlliance’s partner in Japan, MDK Medical, has enrolled the first patient in the clinical study of its novel sirolimus drug-eluting balloon (DEB), SELUTION SLR, for the treatment of peripheral arterial disease (PAD). This follows the acceptance of a Clinical Trial Notification (CTN) by Japan’s Pharmaceutical and Medical Device Agency (PMDA). The study involves up to 132 patients across a number of centres in Japan. Its objective is to assess the safety and efficacy of SELUTION SLR for the treatment of lesions of superficial femoral arteries and/or popliteal arteries. The study is a prospective, controlled, multicentre, open, single-arm clinical investigation. Its primary endpoint will be the primary patency rate at twelve months. Secondary endpoints will include major adverse events/TLR, primary patency, and the change of Rutherford classification/ABI/WIQ. “We are extremely pleased with the regulatory and quality expertise demonstrated by our partner MDK, and particularly proud that Japanese patients can now benefit from our unique technology. This is the first sirolimus drug-eluting balloon implanted in Japan, where the current paclitaxelcoated balloon market generates more than US$100 million in revenue”, commented MedAlliance chairman and CEO Jeffrey B Jump. In February 2019, MedAlliance

became the first DEB company in the world to receive Breakthrough Device Designation status for a sirolimus DEB from the US Food and Drug Administration (FDA). SELUTION SLR has now achieved three separate FDA Breakthrough Device Designations: for the treatment of AVFistula; coronary in-stent restenosis and peripheral below-the-knee lesions. The company announced the enrolment of the first patient in its FDA IDE pivotal coronary trial earlier this year. In February 2020, MedAlliance announced the award of its first CE mark approval: for SELUTION SLR in the treatment of PAD. In May 2020, the company announced the award of its second CE mark: SELUTION SLR 014 PTCA for the treatment of coronary arterial disease (CAD).

Supera peripheral stent system

First patients enrolled in SUPERSURG study of Supera peripheral stent system

ID3 Medical Belgium has announced the first two enrolments in the SUPERSURG study to investigate the safety and efficacy of Abbott’s Supera peripheral stent system versus surgical endarterectomy in treating patients with common femoral artery disease, with and without femoral bifurcation involvement. The physician initiated, prospective, multicentre, randomised study is set to enrol 286 patients at 13 centres in four European countries (Belgium, Poland, the Netherlands, and the UK). Patients will be stratified first based on three criteria: obesity, calcification, and femoral bifurcation involvement. After this stratification, consented patients will be 1:1 randomised in an open surgical or endovascular arm. In addition to superior safety and noninferior efficacy of the Supera peripheral stent system arm as primary endpoints, the study will also assess core lab-based angiographical outcomes post common femoral endarterectomy in a subcohort of 40 patients. The principal investigator of the SUPERSURG study is Koen Deloose, head of the Department of Vascular Surgery at AZ Sint Blasius Hospital in Dendermonde, Belgium, who performed the first two procedures (one open and one endo) in the trial. “My enthusiasm about the use of the Supera peripheral stent system in the common femoral area was initiated by some case experiences at high risk for surgery with great longer-term

follow-up,” comments Deloose in ID3 Medical’s announcement. “Based on these findings, we set up the physician-initiated single-arm VMI-CFA trial,” Deloose continues. “The 12- and 24-months outcomes of this 100-patient cohort, presented at VIVA 2019, confirmed our initial enthusiasm with core lab-based primary patencies of 95% and 93%, respectively, and freedom from target lesion revascularisation (TLR) of 98% at two years (in press). As these results were very close to our surgical data, but with lower complication rates, the idea for a head-to-head randomisation between both treatment strategies, with the same stringent assessment methods was born. With a support grant from Abbott Vascular, we were able to launch this exciting project”. Deloose concludes: “Based on the outcome of this trial, I hope to be able to define subgroups of patients who are better treated with surgery, others with a minimal invasive Supera peripheral stent system implantation. I am convinced that there will be a place for both complementary strategies in the vascular future.”

New study shows advantages of Ellipsys system in creating reliable dialysis access

A new study shows significant benefits of the Ellipsys vascular access system (Avenu Medical) in easily and safely creating durable vascular access for endstage renal disease (ESRD) patients who require haemodialysis. According to an Avenu Medical press release, the system also offers a standardised process for using the minimally invasive technology that other physicians can follow to reproduce the results, which “will make it easier for more practitioners to adopt this patient-friendly approach to dialysis access,” explained lead author Alexandros Mallios, a vascular surgeon at Institut Mutualiste Montsouris of Paris, France. Published in the Journal of Vascular Surgery (JVS), this marks the largest study of any percutaneous arteriovenous fistula (pAVF) technique to date. Of the 232 patients who had an Ellipsys pAVF created between May 2017 and July 2019, there were no adverse events and 96% still had fully functioning fistulas with strong blood flow after a year. That “patency rate” is higher than published rates for surgically created fistulas, which average about 60% after one year. “Vascular access is quite literally the lifeline for dialysis patients,” said Mallios. “The advantages of the percutaneous Ellipsys fistula are that it is a very safe, simple, and reproducible way to create a fistula that will function for a long time with minimal interventions.”

Avenu Medical Ellipsys catheter

Issue 79 | September 2020

Market watch 43

Industry News Over 15,000 delegates attended ECR 2020

The European Society of Radiology (ESR) announced attendance was up for its virtual European Congress of Radiology (ECR) 2020, which took place from 15–19 July. More than 15,000 professional delegates from 130 countries attended the virtual meeting, an increase of 5% compared with attendance at the virtual portion of ECR 2019. In addition, more than 2,000 people tuned in to the Imaging Interpretation Quiz, which was broadcasted live this year from Australia. Furthermore, 216 companies exhibited at the meeting’s virtual exhibition, the ESR noted. Through the interactive experience, vendors could hold product demonstrations, host webinars, and invite attendees to visit their digital booths. The meeting featured online educational, scientific, interactive, and industry-specific content, including more than 50 live sessions, and attendees could earn up to 28 continuing education credits. In a 21 July statement, congress president Boris Brkljačić (University of Zagreb School of Medicine, Zagreb, Croatia) deemed the virtual meeting a success. “When we decided to convert ECR 2020 into an online-only congress, there was a lot of uncertainty about how this would look and whether it would still be possible to capture the magic of ECR in a digital format,” he stated in a press release. “After an incredible congress week, I am extremely pleased to say, there are no longer any doubts.”

Penumbra augments vascular franchise with latest Indigo System launch

The Indigo System Lightning 12 (Penumbra) is now commercially available in the USA, the company has revealed. In addition, Penumbra has announced the appointment of interventional radiologist Corey L Teigen (formerly Sanford Health, Fargo, USA) as chief scientific officer, and interventional radiologist James Benenati (formerly Miami Cardiac & Vascular Institute, Baptist Hospital, Miami, USA) as chief medical officer. Both positions have been newly created. The Indigo System Lightning 12 is the company’s next generation aspiration system for peripheral thrombectomy. Lightning 12 combines the new Indigo System CAT12 aspiration catheter with Lightning intelligent aspiration, enabling physicians to focus on optimising thrombus removal using the system’s clot detection mechanism. CAT12 is a large-lumen aspiration catheter that incorporates novel laser-cut hypotubebased catheter engineering to provide advanced deliverability and torqueability within the body, a company press

Lightning12 Intelligent Aspiration system

release describes. This combination of intelligent aspiration and large-lumen catheter engineering makes Lightning 12 Penumbra’s most advanced clot removal technology. “Penumbra continues to lead the field of clot management by bringing highly innovative technology to address the challenges that we as physicians face while caring for our patients,” says Frank Arko (Sanger Heart and Vascular Institute, Charlotte, USA). “When dealing with thrombus, we have learned that it is the combination of the catheter along with powered aspiration that yields the most effective results. Lightning 12 with intelligent aspiration is a giant leap forward for the field of thrombectomy, and we have been very impressed with the early results at Sanger.” “The simplicity of Lightning intelligent aspiration combined with the significant advancements in catheter engineering will enable us as physicians to get closer to our thrombus removal goal in a safe manner, as well as our goal of improving clinical outcomes for our patients,” says Patrick Muck (Good Samaritan Hospital, Cincinnati, USA). “Lightning 12 provides physicians with an integrated system that not only removes large amounts of thrombus but also detects and manages clot removal,” comments Jay Mathews (Manatee Memorial Hospital, Bradenton, USA). “This is a very important advancement for the field of thrombus management, and our initial experience at Manatee Memorial with this technology shows us that we are now closer to single-setting care for our patients.”

Interventional radiologist Jim Reekers awarded ESR Gold Medal

Jim Reekers (Amsterdam UMC, Amsterdam, The Netherlands), Editor-in-chief of CVIR Endovascular, was awarded the European Society of Radiology (ESR) Jim Reekers

Gold Medal at this year’s—virtual— European Congress of Radiology (ECR; 15–19 July). Reekers is a former president of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE), and a professor Emeritus of Radiology and Interventional Radiology at the University of Amsterdam. He has received the ESR Gold Medal in recognition of his achievements in the field of interventional radiology (IR). In a statement on their website, CVIR Endovascular say: “We hope [this award] will increase the visibility of IR and the importance of endovascular procedures”. “It means a lot,” Reekers tells this newspaper, when asked about the impact of a prominent interventional radiologist receiving the Gold Medal award at the largest European radiology congress. “I think that diagnostic radiology (DR) is the basis for any interventional radiologist. Up to date diagnostic skills—and that means understanding the whole spectrum of diagnostic radiology—is mandatory to be an IR expert. Any medical specialist performing endovascular or interventional oncology procedures without high level diagnostic skills will always stay a craftsman, sometimes useful, but will never be able to make the real difference. Performing IR without up to date diagnostic skills is like driving with your eyes closed, and hoping for the best.” Writing on Twitter, Reekers’ colleague Rick van Rijn (also Amsterdam UMC, Amsterdam, The Netherlands) wrote: “Proud moment for Dutch Radiology and for a great and inspiring colleague. For several years I have had the pleasure to work with him at the same department at the Amsterdam UMC #welldeserved”. “I see this as a great honour,” Reekers says, “the golden crown on my career as an interventional radiologist (and trained radiologist), an innovator, a researcher, a mentor, and a teacher. To be only the second Dutch radiologist to receive this honour feels very special to me. This award symbolises to me personally that diagnostic and interventional radiology should always stay one close family. On equal base, with full clinical responsibilities for IR, and permanent cross fertilisation.” Radiologists Richard FitzGerald (Royal Wolverhampton Hospitals National Health Service [NHS] Trust, Wolverhampton, UK) and Katrine Riklund (Umeå University, Umeå, Sweden) also received Gold Medals at this year’s ECR.

Terumo acquires Quirem Medical

Terumo Corporation has announced it has completed the acquisition of Quirem Medical, a Netherlands-based healthcare start-up specialising in the development of nextgeneration microspheres for selective internal radiation therapy (SIRT),

a treatment for liver tumours. Under the terms of the agreement, Terumo acquired 80.1% of the shares of Quirem Medical. This is over and above its current share position of 19.9%, making Quirem Medical now a wholly owned subsidiary of Terumo. Terumo will make a one-time, up-front payment of US$20 million, with up to US$25 million additional payments based on the achievement of future milestones by 2030. It will be funded through cash on hand and will not significantly impact the company’s financial projections for the current fiscal year ending 31 March 2021. Quirem Medical has developed and manufactures QuiremSpheres, the only commercially available microspheres containing the radioactive isotope Holmium-166. Recent trials have shown the safety and efficacy of holmium microspheres for the treatment of unresectable liver cancer. To improve patient selection, therapy planning, and treatment verification, QuiremSpheres can be visualised and quantified even in low concentrations by means of singlephoton emission computed tomography (SPECT) and magnetic resonance imaging (MRI). This is unique and cannot be done with currently available Yttrium-90 based microspheres. Quirem Medical also produces QuiremScout, a low dose holmium microsphere that helps evaluate the biodistribution of microspheres prior to therapy, and a dosimetry software package, Q-Suite, which is used to plan QuiremSpheres treatments based on QuiremScout dose imaging. Q-Suite is also able to determine SIRT success immediately after the procedure by converting SPECT and MR imaging into absorbed dose distributions. Together, these three integrated products (QuiremSpheres, QuiremScout, and Q-Suite) make up the full Holmium SIRT Platform. The Holmium Platform equips physicians with the necessary tools to optimise SIRT outcomes through more personalised treatment, a Terumo press release asserts, addressing the individual needs of each patient. QuiremSpheres, QuiremScout, and Q-Suite are CE-marked and currently available in Europe, the Middle East, and Africa. Terumo intends to launch the Holmium Platform globally as part of the ongoing expansion of its interventional oncology portfolio. The global interventional oncology market value is more than US$1 billion, which is a rapidly growing field with a compound annual growth rate (CAGR) of 7%. Within this field, SIRT is one of the main treatments that is expected to help to drive this growth year on year. Terumo has been building its presence in the interventional oncology field, with product offerings such as the micro catheter system (Progreat), compressible microspheres for embolization (HydroPearl), drug-eluting microspheres (LifePearl), and biodegradable drugeluting microspheres (BioPearl). In 2015, Terumo invested in Quirem Medical and became the exclusive global distributor of their technology.

Issue 79 | September 2020

Market watch 45

Product News

Avicenna intracranial haemorrage and large vessel occlusion identified

Avicenna.AI secures FDA clearance for its CINA Head neurovascular imaging artificial intelligence tool

Medical imaging artificial intelligence (AI) specialist Avicenna.AI has announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its CINA Head triage AI solution for neurovascular emergencies. The FDA’s decision covers CINA’s automatic detection capabilities for both intracranial haemorrhage and large vessel occlusion (LVO) from CT-scan imaging. Stroke is a leading cause of death in the USA, with more than 795,000 strokes resulting in more than 100,000 deaths each year. It is estimated that up to a third of the most common type of stroke are caused by LVO, when a clot blocks the circulation of the blood in the brain. Around one in 10 strokes are thought to be caused by intracranial haemorrhage. Using a combination of deep learning and machine learning technologies, CINA Head automatically detects and prioritises acute intracranial haemorrhage and LVO cases within 20 seconds, seamlessly alerting the radiologist within their existing systems and workflow. Peter Chang, radiologist and cofounder of Avicenna.AI, says: “When dealing with a stroke, time is of the essence and being able to prioritise effectively is critical to saving lives and improving outcomes. Not only does CINA Head help radiologists to identify pathologies quickly, but also to highlight those that require the most urgent care.” CINA’s intracranial haemorrhage detection capability was validated using data from 814 cases conducted at more than 250 imaging centres across the USA, with 96% accuracy, 91.4% sensitivity, and 97.5% specificity. The product’s LVO detection capability was validated based on 476 cases, with 97.7% accuracy, 97.9% sensitivity, and 97.6% specificity. Cyril Di Grandi, co-founder and CEO of Avicenna.AI, comments: “We are excited to have received FDA clearance

for CINA Head and are looking forward to working with emergency departments and stroke centres across the USA to help improve detection, decisionmaking, and patient outcomes. As a triage AI tool that identifies multiple pathologies, we believe that CINA Head delivers more value than AI tools or algorithms that only target a single condition.” CINA Head is the first in a family of AI tools for emergency radiology being developed by Avicenna.AI. Subsequent products spanning the trauma and

release. By enabling synchronised injector triggering from the MRI scanner operator console and a more efficient workflow, the imaging system interface allows users to conduct high quality, consistent contrast-enhanced procedures and spend more time focusing on the patient. Bayer and Siemens claim. In a conventional, manuallycontrolled setting, radiographers must constantly plan, monitor, and time the various steps on the injector and scanner workstations separately during contrast-enhanced MRI procedures. If the required steps are not optimallytimed and synchronised, poor image quality may be generated, which can delay diagnosis as contrast-enhanced scans then have to be repeated. This can result in additional costs to healthcare systems and may cause unnecessary stress and inconvenience for patients as well as healthcare providers. “Together with Siemens Healthineers, we were able to design an interface that directly addresses the challenges of conventional contrast-enhanced dynamic MRI workflows and improves both the user and patient experience,” comments Olaf Weber, head of Radiology Research and Development at Bayer. “This is a very exciting time as we introduce the new technology to our customers that will further improve their experience with our MRXperion injector. We believe that the new interface will assist in allowing the MRI radiographers more time to care for their patients,” says Lynne Collins, country head Radiology at Bayer UK/ Ireland. The imaging system interface recently gained CE mark certification.

of 18–78mm, and comes in working lengths of 90, 130, and 170cm, the largest range of iliac stent sizes on the market, a company press release states. Biotronik claim that the thin-strut stent combined with the low crossing profile of the balloon catheter delivery system enhances deliverability. “The new Dynetic-35 is a true improvement over the previousgeneration stainless steel iliac stent. The flexibility, lower profile, and improved deliverability allow direct stenting even in more challenging lesions,” says Michael Lichtenberg (Arnsberg Vascular Center, Arnsberg, Germany). “In my clinical experience with the new stent system, I have been impressed by the smooth placement and deployment for a direct stenting approach, as well as the radial strength of the stent.” With the 170cm catheter length option, the Dynetic-35 system also enables a radial access approach. “In my practice, I often have the need to use radial access to treat iliac artery disease, which provides more patient comfort and earlier ambulation,” explains Mercedes Guerra-Requena (Guadalajara Hospital, Guadalajara, Spain). “Until now, available options for a radial approach have been limited. Fortunately, the new Dynetic-35 stent’s 170cm length delivery system option and 6F sheath compatibility enables me to comfortably use a radial approach.” “The next-generation Dynetic-35 is a testament to BIOTRONIK’s continued mission to develop innovative devices that improve the lives of patients,” says Alexander Uhl, president of Vascular Intervention at Biotronik. “We are proud to be able to offer our signature

Dynetic-35 balloon expandable cobalt chromium iliac stent system gains CE mark vascular fields are expected to be unveiled in the next 12 months.

Bayer and Siemens Healthineers present first synchronised imaging system interface for MRI

A new imaging system interface for magnetic resonance imaging (MRI) was presented on the first day of the 2020 European Congress of Radiology (ECR) annual meeting, taking place virtually for the first time from 15–19 July. The imaging system interface is a joint hardware and software development from Bayer and Siemens Healthineers, and the first injector scanner interface for the MRI suite. It synchronises the MEDRAD MRXperion MR injection system from Bayer and the Siemens Healthineers MR scanner, thereby overcoming significant challenges posed by the complex process used in conventional contrast-enhanced dynamic MRI, which can result in suboptimal imaging, according to a joint company press

Dynetic-35, the balloon-expandable cobalt chromium iliac stent system from Biotronik, is now commercially available in Europe. Indicated for the treatment of de novo or restenotic lesions in the iliac arteries, the product is approved for use in Europe and other markets that recognise CE mark certification. The Dynetic-35 stent size matrix is 6F compatible, including stent diameters of 5–10mm and lengths

Dynetic-35 iliac stent system

thin-strut stent design in the largest size range on the market while staying 6F compatible for the entire product line.”

Sirtex Medical launches SIROS system for SIRSpheres resin microspheres delivery A new system designed to deliver Yttrium-90 (Y-90) resin microspheres during targeted liver cancer therapies, SIROS (Sirtex) has launched commercially. A company press release states: “SIROS offers a visual, intuitive and versatile option for interventional radiologists to deliver SIR-Spheres to patients with liver cancer. With the system’s visually-controlled administration, physicians can determine and adjust the precise

September 2020 | Issue 79

46 Market watch

Product News quantity and speed of SIR-Spheres microspheres delivery. Additionally, the system is designed to be simple to use yet versatile enough to allow expanded options for patient-tailored delivery.” SIROS’ design features a peeland-place tubing set, a proprietary needleless D-Vial specifically designed to suspend SIR-Spheres into a vortex that may allow for a more even distribution, and a locking cover to safely secure the microspheres during delivery. A three-step setup provides quick and simple administration and disposal. “SIROS brings world-class expertise and innovation together to provide interventional radiologists with the support and technology they need to treat patients with liver cancer,” says Kevin R Smith, chief executive officer of Sirtex.

Surmodics receives FDA 510(k) clearance for Sublime radial access 0.014 RX PTA dilatation catheter

Surmodics recently announced it has received US Food and Drug Administration (FDA) 510(k) clearance for its Sublime radial access 0.014 rapid exchange (RX) percutaneous transluminal angioplasty (PTA) dilatation catheter. According to a press release, the Sublime radial access 0.014 RX PTA catheter allows below-the-knee access through a transradial approach by providing the longest working length (250cm) on the market. Outer balloon diameters range from 2–4mm with balloon lengths between 20mm and 220mm. The product joins the previously cleared Sublime radial guide sheath within the company’s Sublime

radial access platform and is designed to facilitate radial access for the treatment of above- or below-the-knee arteries. “FDA 510(k) approval of the Sublime radial access 0.014 RX PTA dilation catheter is another step forward in our strategy to become a provider of wholeproduct vascular solutions through the design, development and manufacturing of highly differentiated products,” said Gary Maharaj, Surmodics president and CEO. “The continued expansion of our Sublime radial access platform demonstrates our commitment to developing the transradial peripheral market space through the introduction of longer, lower-profile devices that fill unmet physician and patient needs.” Radial access offers many benefits relative to femoral access including reduced puncture site bleeding complications, earlier ambulation, reduced length of hospital stay, and lower healthcare costs. Although transradial access has become a mainstream technique in percutaneous coronary interventions (PCI), it has

been less widely adopted in peripheral interventions due to the limited availability of purpose-designed access and therapeutic devices. The Sublime 0.014 RX PTA dilatation catheter is compatible with a 5Fr guide sheath and is designed to provide the performance of an over-the-wire PTA catheter in an RX platform. Its proprietary reinforced shaft technology with flexible, kink-resistant construction and a tapered RX port transition are designed for optimal trackability and push through distal tortuosity.

Sublime radial access 0.014 RX PTA dilatation catheter

Calendar of events 4–6 September Global Embolization Cancer Symposium Technologies (GEST) US Virtual

6–27 October Symposium on Clinical Interventional Oncology (CIO) 2020 ONLINE Virtual

www.embolization.com

www.theiomeeting.com

8–11 September CX Aortic Vienna Virtual

November 2020–February 2021 The CIRSE webinars: Interventional Oncology 2.0 Virtual

www.cxsymposium.com/cxaortic

12–15 September Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Annual Meeting 2020 Virtual www.cirse.org/events

www.ecio.org

30 November–4 December British Society of Interventional Radiology (BSIR) Annual Meeting 2020 Virtual www.bsir.org/meetings

16–18 December The International Conference on Complications in Interventional Radiology (ICCIR) Vienna, Austria www.cirse.org/events/iccir

16–19 December European Conference on Embolotherapy (ET) 2020 Vienna, Austria www.etconference.org

17–20 January 2021 International Symposium on Endovascular Therapy (ISET) Hollywood, USA

26–29 January 2021 Leipzig Interventional Course (LINC) Leipzig, Germany www.leipzig-interventional-course.com

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

11–14 April 2021 European Conference of Interventional Oncology (ECIO) 2020 Stockholm, Sweden www.ecio.org

www.iset.org

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

Mar

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