Adverse events were determined according to Cardiovascular and Interventional Radiology Society of Europe (CIRSE) criteria, and Bilhim stated that they did not consider frequency, urethral burning sensation or slight pelvic pain lasting for one to three days post-PAE as being in this category, but rather as post-PAE syndrome.
et al conducted this single-centre retrospective study in 1,072 patients with followup over a 10-year period to assess the outcomes of PAE for, as stated in the paper’s title, BPH in patients with lower urinary tract symptoms (LUTS).
Treating placenta accreta spectrum with pelvicmultivesselembolization
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In his presentation, Bilhim reported that the study ran from March 2009–2019, and the 1,072 patients who were studied excluded those who did not have follow-up (11% of the original study population), the 1% in whom PAE was a technical failure and the 3% who were diagnosed with prostate cancer during follow-up.Bilhimwent on to detail how each patient was evaluated for International Prostate Symptom Score (IPSS) and quality of life (QoL), prostate volume (PV)—measured with transrectal ultrasound—prostate-specific
Bilhim
The authors begin the paper by outlining some of the pre-existing research in the area of PAE for BPH— data have shown that compared to prostatic surgery, PAE can achieve “similar LUTS improvements with a lower adverse event profile.” However, surgery leads to improvement in all BPH objective measurements and data suggest that retreatment rates for patients who underwent prostatic surgery may also be lower.
The findings of a collaborative research project at the University of California San Diego (UCSD), San Diego, USA were presented in an abstract titled ‘Multivessel pelvic embolization during caesarean hysterectomy for placenta accreta spectrum: A single-centre experience and comparison to internal iliac artery balloon occlusion’ at the Society of Interventional Radiology (SIR) 2022 Annual Meeting (11–16 June, Boston, USA). The abstract’s lead author, Christine Boone (UCSD, San Diego, USA) explained to Interventional News her surprise at the extent of blood loss reduction with embolization compared to internal iliac artery balloon occlusion (IIABO), alongside other noteworthy findings.
THIS COLLABORATION AMONG interventional radiology, obstetrics and gynaecology, and maternal foetal medicine teams aimed to compare how intraoperative pelvic embolization performed to reduce blood loss during surgical management of placenta accreta spectrum (PAS) versus IIABO.
Regarding the study’s results, Boone first outlined her prediction that blood loss would be “similar or better” among the embolization group. “But what surprised me was by how much [embolization improved outcomes],” Boone went on to acknowledge. In the IIABO group, she noted, median blood loss was 2.5
Continued on page 2 Continued on page 4BilhimTiago Profile: DenysAlbanpage22
“Promising” 10-year data on PAE for benign prostatic presentedhyperplasiaatET
antigen (PSA), peak urinary flow rate (Qmax) and postvoid residual (PVR) volume. Follow-up appointments took place yearly and also evaluated use of prostatic medication, reintervention rates and repeat PAE and prostatectomy rates. In terms of embolic agent, Bilhim proceeded to explain that over the 10 years, various embolic agents were used. These were non-spherical polyvinyl alcohol (PVA) particles, measuring 100–300 micrometres and spherical PVA microspheres, measuring 300–500 micrometres. Some patients received treatment with trisacryl gelatin microspheres measuring 100–500 micrometres, or 250-400 micrometres polyzene-coated hydrogel microspheres. Notably, the first group treated within the study remit received PVA particles, so their follow-up was longer. Mean follow-up time was 4.39±2.37 years.
Tiago Bilhim (Saint Louis Hospital, Lisbon, Portugal) presented during the Scientific Paper session at this year’s European Conference on Embolotherapy (ET; 22–25 June, Nice, France), and won the award of best abstract for his and co-authors’ ‘Long-term outcome of prostatic artery embolization for patients with benign prostatic hyperplasia’. A key takeaway from his presentation was that prostatic artery embolization (PAE) appears a “safe and effective treatment option for patients with benign prostatic hyperplasia [BPH]”.
Bilhim then proceeded to relay his results to delegates in the audience: at the final follow-up appointment, mean IPSS and QoL improvements were -10.14±8.34 (p<.0001) and -1.87±1.48 (p<.0001) points, mean PV reduction was -6.82±41.11 cm³ (p=0.7779), mean PSA reduction was -1.12±4.60ng/ mL (p=0.9713), mean Qmax increase was 2.72±6.38 mL/s (p=0.0005), mean PVR reduction was -8.35±135.75mL (p=0.6786) and mean IIEF5 (International Index of Erectile Function-5) improvement was 0.18±7.40 points (p=0.4546).
Prostatectomy rates were 1.1% at one year, 11.6% at five years and 35.0% at 10 years, Bilhim reported.
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Regarding the frequently asked question of how PAE compares to other procedures, Bilhim sought to clarify that “you cannot compare recovery and morbidity between PAE and [surgical resection].” It is more appropriate and beneficial to draw comparisons between PAE and other MISTs, such as those which are commonly carried out in the USA, he noted.
The number of patients who required prostatic medication after PAE was 335, or 31.3%. The reintervention and repeat PAE rates were 3.4% and 2.3% at one year, 21.1% and 9.5% at five years and 58.1% and 23.1% at 10 years, respectively.
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Rounding up the post-presentation discussion, Bilhim concluded that these study data are “good” for him—“I can tell [patients] about 10-year likely outcomes.” This study presents the largest PAE cohort with the longest follow-up data so far, he also claimed.
The National Institutes of Health (NIH) has awarded a grant to Kytai Nguyen (University of Texas at Arlington, Arlington, USA) to develop a biodegradabledual-capability nanoparticle for peripheral arterial disease (PAD) treatment. Nguyen hopes to succeed in creating a particle that can achieve targeted drug delivery, while also enabling a clinician to see where this fluorescent drug-containing particle has travelled to within the patient’s body.
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“Promising” 10-year findings on PAE for BPH presented at ET 2022
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Bilhim et al were able to draw the conclusion that PAE gives patients lasting and long-term LUTS relief and that reintervention rates are 20% in the first five years, rising to between 30 and 60% >five years postPAE. Addressing the ET audience, Bilhim declared PAE a “safe and effective treatment option for patients with BPH.” The study yielded “promising” findings,
In terms of difference in outcomes among the different embolic agent groups, the paper acknowledges that PVA led to lower rates of penile skin lesions, haematuria and rectal bleeding after PAE compared to the other spherical embolic agents. A possible explanation for this could be that PVA offers a lower permanent vessel occlusion.
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the presenter added, among which was that 74% of patients remained prostatectomy-free, demonstrating the potential for repeat PAE to ensure treatment effectiveness durability.
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The presenter also noted that the study saw a 90% acute urinary retention resolution rate, with the other 10% having to have surgery, and the rate of post-PAE syndrome was 23%.
For more on this story go to page 17.
He admitted that “we need more long-term data to keep on proving that PAE is a good alternative treatment to prostatectomy/transurethral resection of the prostate (TURP).” Studies with large cohorts are also necessary, Bilhim added, to “fill this gap in the knowledge” around BPH treatment and PAE. Future trials should compare PAE with other minimally invasive surgical treatments (MISTs), as well as look more closely at the differences in outcome when using various embolic agents, Bilhim suggested. Long-term reintervention rates also mean that the benefits of PAE in terms of faster recovery, it being less invasive with fewer adverse events and better at preserving ejaculation, “must be viewed with caution,” Bilhim
n WINNING ABSTRACTS FROM GEST AND SIR: This summer, these two US meetings saw a range of scientific abstracts recognised for their contribution to interventional radiology (IR) research. Among the topics of the winning abstracts were registry results of yttrium-90 (Y90) radioembolization of colorectal cancer metastatic to the liver, as well as multicentre cohort study data on prostatic artery embolization, and the outcomes of a randomised controlled trial comparing intradiscal oxygen-ozone chemonucleolysis to microdiscectomy for lumbar disc herniation radiculopathy.
[This is] a safe and effective treatment option for patients with BPH.”
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Sessionadvised.moderator and meeting deputy chairperson Otto van Delden (University Medical Centers Amsterdam, Amsterdam, The Netherlands) asked Bilhim after he had finished presenting whether “[you can] use [whatever agent] you want.” Bilhim responded in the affirmative, before explaining the following: “What I have seen is that when you do PAE repeatedly, even though I could not prove this, [there seems to be] more recanalisation of the native prostatic artery with PVA than with spherical particles.” Nevertheless, Bilhim asserted, he has seen “no big clinical difference” among the different embolic agents—“all patients will have revascularisation from different origins.”
For more on this story go to page 21.
Reintervention, IPSS over 15, or QoL >3 were all considered ‘clinical failure,’ with need for prostatic medication registered but not counted as failure.
inNewsbrief
Bilhim showed his awareness of his study’s “many limitations”—namely that it was carried out retrospectively with no controls and that they “lost patients during follow-up.” Comparing the embolic agents also made the study more difficult because of different follow-up times for each group, but they did control for this factor with multivariable Cox regression analyses, Bilhim clarified.
Continued from page 1
Editors-in-chief:
n EUROPE’S FIRST IO FOUNDATION COURSE: Philippe Pereira (SLK-Kliniken, Heilbronn, Germany) speaks to Interventional News about the significance of the launch of a European foundation course in interventional oncology (IO), which took place at the European Congress on Interventional Oncology (ECIO; 24–27 April, Vienna, Austria). He discusses why multidisciplinary strategies are key to IO practice, and why interventional oncologists should be trained to carry out more than a technician’s role. For more on this story go to page 7.
Other trends observed during the study were that unilateral PAE was a significant predictor of clinical failure and reintervention and that those who received a repeat PAE (n=25, 25.8%) were more likely to undergo prostatectomy compared to those who only received one PAE procedure.
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In conclusion, Boone told Interventional News how she sees these results as “huge”, and she is excited to see the impact they might have for PAS care. She also took the opportunity to give insight into her other area of research. Currently used in the treatment planning of pelvic venous disease at UCSD Boone shared her interest in taking 4D flow magnetic resonance imaging (MRI) into the area of PAS, to see if it could aid in identifying where the placenta is drawing blood from in each specific patient’s case, ahead of the procedure.
September 2022 | Issue874 Placenta Accreta Spectrum PhotographyGLamontePortrait:
litres, where any amount over one litre in a caesarean section delivery is considered a haemorrhage. “It was a lot more before [occlusion], and people had to get blood transfusions,” Boone said, contextualising the benefit that IIABO intervention brings. Yet, the median blood loss, she then noted, with embolization, was only 675ml “which is not even considered a haemorrhage by the criteria for caesarean [delivery].” In this group, no patients needed transfusions, which was not the case for the occlusion group. Boone labelled this “a really striking difference,” accounting for her surprise at her study’s findings. Of note, the comparative procedure times for IIABO and embolization, which were an average of 35 and 64 minutes, respectively, and Boone admitted that the duration of the procedures is an important consideration. While the longer duration of the embolization procedures did not present issues in the context of the study, it may in some cases.
Boone began by relaying to Interventional News how she was inspired to study the applications of interventional radiology (IR) in women’s health after “[repeatedly] hearing about how maternal mortality was increasing in the USA” as she was finishing medical school. “I thought this was so strange,” she admitted, given “how we pay so much for healthcare in this country.”
Expanding on what drew her into women’s health and IR, she conveyed her passion for being “able to intervene, especially in postpartum haemorrhage situations” and that “that was the thing that would often kill women in childbirth.” Boone went on to underline how haemorrhage management can be achieved in “as little as 15 minutes,” and that this is one of the reasons why she sees her area of research as a “really exciting opportunity to help.”
Continued from page 1 BooneChristine
like a cancer.” Spreading greater awareness about the disease is, therefore, something about which Boone feelsQuizzedstrongly.on the two treatment options compared in her research project, Boone first conveyed how there is, currently, no standard of care regarding PAS treatment. Different clinicians may choose different approaches, including hysterectomy, as well as leaving the placenta in place to manage bleeding (the latter, however, brings with it risk of infection). IR provides a further swathe of treatment options, such as embolization and balloon occlusion, Boone detailed.
Despite this advantage of IIABO, Boone then shared her thoughts on why embolization may work better still: “The placenta in PAS does not respect [anatomic] boundaries, including its vascular supply and so it can pull blood from the abdominal wall [for example].” This may mean that, in certain cases, the IIABO’s role is insufficient, as it is not stopping blood flow to additional vessels.. Embolization is favourable in these cases, Boone outlined, expanding on this point with the following explanation: “[with embolization], we are looking for collaterals […] we can adapt the therapy to the patient and where the blood is coming from.”
According to Boone, this application of balloon occlusion “came earlier”, but it is not necessarily used more often than embolization nowadays, as there is not data available on this. Nevertheless, the
The placenta in PAS does not respect itsboundaries,[anatomic]includingvascularsupply.”
The discussion then turned to the specific particles one can use for embolization to treat PAS. Boone began by conceding that no study to date has compared particle types for this indication. There can be different approaches to embolization and the type of particle is an important consideration in this strategy. Studies to determine optimal embolization strategies and embolic type would be a significant next step. Another “good future direction” for research would be subgroup analysis, as the study is ongoing. Boone explained, however, for now, the number of patients is too low for this to be possible.“There is definitely something to be said for gravidity [and there also could be] for the number of caesarean sections a patient has had,” Boone stated.
Learning more about placenta accreta spectrum disorders, Boone highlighted as “fascinating”, not just from a treatment point of view, but also from a scientific standpoint. “The more I read about it, the more I learned that it was almost like a malignancy […] it does not respect boundaries […] and behaves
Treating placenta accreta spectrum with multivessel pelvic embolization
Intraoperative multivessel pelvic embolization for surgical management of placenta accreta spectrum. Left: preprocedural fluoroscopic aortogram demonstrating extensive uterine vessels and placental collaterals. Right: post-procedural fluoroscopic aortogram demonstrating blockage of blood flow to the placental collaterals.
The abstract was also recognised as ‘exceptional’ among those presented at the meeting. Additionally, Boone received the SIR Foundation Resident Research Award during the meeting’s award ceremony plenary session on Monday 13 June.
fact remains that there is more research on the former type of treatment. Aortic balloons are used in trauma situations, and so are widely seen as an effective method for stopping blood flow, hence the recourse to them in a PAS treatment scenario, Boone proceeded. She then detailed how aortic balloons have, in fact, been used for PAS cases during surgery, but that this threatens limbs and other organs by stopping blood flow to everywhere below where the balloon is inflated. Consequently, “the benefit of the [IIABO] is that it is more selective […]—the internal iliac artery [supplies] blood to everything in the pelvis, but the legs are excluded”.
“It would be interesting to see how radiation doses changed during this period, as perhaps patient doses decreased due to increased utilisation of ultrasound,” Keefe muses, while also contemplating how doses may actually have increased “if interventionalists were less familiar with alternative contrast agents and therefore the procedure was made more challenging and lengthier.”
Roberto Luigi Cazzato is associate professor at the Department of Interventional Radiology, University Hospital of Strasbourg (Strasbourg, France).
Interventional radiology outpatient clinic: Another success story in IR’s bright history
September 2022 | Issue876 Comment & Analysis
Disclosures: The author declared no relevant disclosures.
In the 2018–2019 period, the cumulative procedure conversion rate, namely, the rate of first consultations that led to an IR procedure, was higher than 85%;
From a patient point of view, Keefe details how they were often “not familiar with the cases performed in the usual manner”, so remained largely unaware
Comment & Analysis
It is not a surprise that in the last decade, IR initiatives intended to increase contact with our patients and improve their care have flourished. From this perspective, two main measures can be adopted: the IROC for consulting patients before and after the intervention; and on the other side, the IRHC, which provides hospital beds
Among the 159 patients being
surveyed to evaluate their satisfaction with the IROC, 99.2% highly appreciated their IROC experience, and pointed out that the main aspects they took into account to evaluate their IROC experience were the quality of secretarial and medical services. These results represent another successful chapter for IR in its so far short, but bright, history. This study points out that as interventional radiologists, we are succeeding in taking care of our patients and that our clinical role is being affirmed, which may pave the way to establishing IRHCs in the nearNevertheless,future.
Prudence recommended despite “preshortage levels” of contrast media
Taking the American College of Radiology (ACR) Committee on Drugs and Contrast Policy’s guidelines statement as a starting point, Keefe and her co-authors recommended using a priority matrix to help manage radiology services in the face of the contrast media shortages. The matrix should encompass the following types of procedures: those requiring iodinated contrast media versus procedures that can be deferred; those that can be performed with alternative imaging modalities such as intravascular ultrasound; and those that can be performed with an alternative contrast media.
Keefe first underscores to Interventional News the impact of the shortage on radiology services: there were many cancellations and delays for non-emergent
The total number of consultations steadily increased from the first to the last year of the study period (from 693 consultations performed in 2011, to 1595 consultations performed in 2019, which accounts for an increase of 130%);
However, “it may be prudent to continue to utilise some of the mitigation strategies full-time,” Keefe advises, citing that nephrology colleagues of hers are in support of such an approach. “Use of air, carbon dioxide, and intravascular ultrasound where applicable can decrease both patient and provider radiation dose during the procedure,” the lead author suggests. Keefe goes on to say that “this may not increase procedural time but perhaps [even] decrease it, while providing [higher-quality] diagnostic imaging in certain situations.”
Interventional radiology (IR) was officially born on January 16, 1964, when Charles Dotter performed the first arterial angioplasty at the Department of Radiology at Oregon Health and Science University (Portland, USA). We still can see the prescription Dotter received from the referring physician, which stated: “VISUALISE BUT DO NOT TRY TO FIX!!!” Roberto Luigi Cazzato speaks to Interventional News about the emergence of IR outpatient clinics (IROCs) and his view that IR hospitalisation clinics (IRHCs) are set to follow suit.
for patients undergoing challenging interventions.Bothofthese solutions are desirable for the development of our specialty. However, the clinical, administrative, and financial input to establish IROCs versus IRHCs differs— it is much less costly to establish an IROC compared to an IRHC. In the last decade, newly built IROCs have flourished, with IRHCs less of a priority. The creation of IROCs is the first step, but we are confident that IRHCs will soon become more common. In the meantime, we can analyse the performance of the IROC so far. In a paper published in CardioVascular and Interventional Radiology (CVIR), the addition of an IROC at the University Hospital of Strasbourg (Strasbourg, France) has had a positive effect on patient care. The results have been quite surprising:
of procedural changes caused by the shortage, such as the employment of a different imaging modality. Many, however, were acutely aware of the delays in imaging and their procedures.
with patients looking for high-quality secretarial and medical services, these results also show that specific training is required for the employees involved in running the IROC.
IN THE WAKE OF THE RECENT PANDEMIC induced iodinated contrast media shortage, Nikki A Keefe (Department of Radiology, University of North Carolina at Chapel Hill, Chapel Hill, USA) outlines the current supply situation. She also shares the response she has had to hers and colleagues’ recommendations—published in May in a Journal of Vascular and Interventional Radiology (JVIR) article.
Our willingness for innovation is not
procedures, and alternative agents used. “Many procedures were transitioned,” she expands, citing how the traditional gastrostomy tube placement replaced the balloon-assisted gastrostomy tube placement, non-contrasted computed tomography (CT) replaced sinogram, and ultrasound-guided saline injections replaced fluoroscopy-guided contrast injections for tube placements.
The article’s lead author also relays how she, personally, “received many questions about using gadolinium, gastrografin and carbon dioxide in unique methods such as within angioplasty balloons.”
Regarding the current state of contrast media availability, Keefe asserts that it seems to be at “pre-shortage levels”, owing to Bracco’s increased production and importation to the US market and GE Healthcare’s production having returned “to normal”.
The entire IR community is becoming increasingly interested and focused on developing this topic; for this reason, the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) has dedicated a lecture to ‘How to establish and run an outpatient clinic’ at its annual meeting (10–14 September, Barcelona, Spain).
Roberto Luigi Cazzato
The above phrase summarises what interventionalists are—dreaming souls looking for innovation. For this reason, it is not surprising that in the last few decades, IR has evolved so rapidly that today, at least one type of IR procedure can be done on any and every organ. Moreover, devices and imaging guidance are becoming so sophisticated and precise that new interventions and clinical outcomes are presented yearly. Therefore, as interventional radiologists, we are succeeding in providing innovation in healthcare.
It may be prudent to continue to utilise some of the mitigation strategies.”
only due to our love for novelty and technology. In our minds, innovation has a purpose, and it is a noble one—to serve our patients! For this reason, we stay in close contact with patients before and after interventional procedures.
The rate of unattended consultations remained stable throughout the entire study period (around 7%);
…interventionalists are […] dreaming souls looking for innovation.”
Despite these advantages, many countries do not have the infrastructure for carrying out IO procedures, and this even includes countries where IR is well
Why is the launch of this course such a landmark event? What will it mean for the area of IO and its trainees going forward?
Thus, currently, even with a large number of patients affected by thyroid nodular disease, robust scientific literature, and the recent publication of specific guidelines, a relatively low percentage of interventional radiologists actively perform MITT in Europe.
Issue87 | September 2022 7Q&A: IO Foundation Course
THYROID NODULES ARE frequently detected in the general European population, the vast majority being benign, symptomless, and thus not requiring any medical action. Nevertheless, a significant number of thyroid nodules, even if benign, can cause compressive symptoms or aesthetic concerns. Furthermore, incidence of thyroid cancer has increased in recent years, and, particularly, small thyroid cancer is increasingly detected, thanks to improved ultrasound imaging and more widespread recourse to thyroid examinations. In both the case of symptomatic benign thyroid nodules and thyroid cancers, the standard treatment has always been surgical removal of half of, or the whole, thyroid.
During ECIO 2022, we had the first ever European foundation course in IO. The foundation course is for interventional radiologists who are not yet familiar with minimally invasive oncological procedures,
What were some of the meeting highlights for you?
Giovanni Mauri
Minimally invasive thyroid treatments in 2022
IO is rapidly continuing to establish itself as the fourth pillar of cancer care alongside medical, surgical and radiation oncology. To the advantage of the right patients, IO can be combined with surgery, systemic treatment and, in some instances, with radiation therapy. Moreover, IO procedures can be hugely beneficial not only for patient recovery times, but also in terms of cost-saving. The most effective way to increase the possibilities for patients to benefit from minimally invasive oncology treatments is for interventional oncologists to practise as fully fledged clinicians rather than as technicians, holding outpatient clinics and participating fully in discussions at multidisciplinary team meetings. In order to do this successfully, they must learn the basics of oncology in relation to the conditions they treat, so that they can engage in meaningful discussions with other clinicians and patients.
under local anaesthesia. This results in significant volumetric reduction of the nodule, which is correlated with a reduction of nodule-related symptoms. In the case of thyroid cancer, MITTs are mainly used to treat papillary thyroid microcarcinomas (papillary thyroid cancers <1 cm), which can be completely ablated without an invasive surgical treatment. Moreover, MITTs have been applied for palliation in larger thyroid nodules, different subtypes, and even for metastatic lymph nodes.
and this day-long course on the basics of oncology, including all surgical disciplines and radiation therapy offers a fantastic introduction to this field. The course came about based on the concept that interventional oncologists must be educated as true medical doctors (oncologists), not just technicians.
This course was the first multinational event after COVID-19. Nevertheless, the course was packed, and there were numerous enthusiastic comments from some of the younger attendees, and also from the experienced clinicians on the faculty.
Disclosures: Mauri declared the following disclosures: advisory boards for Boston Scientific and Terumo, and speaking fees for ECO and RF Medical.
What is your impression of how the course went?
Philippe Pereira on ECIO’s IO Foundation Course launch
It is a bit difficult to answer as the chairman of the meeting (!), but I would say the sessions that focused on combined treatments were a highlight, as this field that is continuously evolving. The sessions gave insight into some of the future developments we will see, underlining that multidisciplinary approaches can achieve some of the best results for lung and metastatic cancer patients in particular. The take-home message is that no single clinician nor oncological specialty alone has the solution for cancer patients. Other highlights were the clinical research sessions that will establish IO in future treatment algorithms, the place of artificial intelligence in IO, but also IO emergencies and the session on IO in paediatrics.
The goal of the course is, ultimately, to improve cancer care by increasing clinicians’ knowledge of multidisciplinary and multimodal treatment strategies: IO offers safe and effective treatment for patients with a variety of malignancies. In recent years, potentially curative interventional radiology (IR) procedures have also emerged, making an increasingly significant contribution to the treatment of cancer patients.
Giovanni Mauri is assistant professor at the University of Milan’s Department of Oncology and Haemato-oncology (Milan, Italy), and an interventional radiologist at the Division of Interventional Radiology at the European Institute of Oncology (Milan, Italy).
A benign thyroid nodule treated by radiofrequency ablation. The nodule is significantly reduced (by 84%) after one year.
established. Across the globe and within Europe too, the spectrum of available IO procedures varies, making it difficult to offer this service reliably to patients. The variation also makes it harder for tumour boards to make multidisciplinary IR treatments recommendations for patients.
Comment & Analysis
And this does not only hold true in a palliative setting. These developments are responsible for establishing IO as the fourth pillar of cancer care, alongside medical, surgical and radiation oncology, as I mentioned. IO procedures, when applied in the right patients, achieve excellent oncological results with fewer complications and shorter hospital stays than conventional surgery. As a result, they are less expensive and more cost-effective..
In the last few years, minimally
Recently, a paper was published in Endocrine by the Italian MITT group members to summarise the information that patients and referring physicians should have access to on MITT for the treatment of benign thyroid nodules.
invasive treatments for the thyroid (MITTs), and particularly imageguided thermal ablation, have gained an increasingly important role in the management of thyroid nodules. In the case of benign thyroid nodules, MITT allows for treating patients without the removal of thyroid tissue, and
The 2022 European Congress on Interventional Oncology (ECIO) took place 24–27 April in Vienna, Austria. Interventional News spoke to chairman Philippe Pereira (SLKKliniken, Heilbronn, Germany) to hear his thoughts on the new addition to the meeting programme for this year: the foundation interventional oncology (IO) course.
PereiraPhilippe
Despite the increasing evidence of safety and efficacy of MITT for the treatment of benign and malignant thyroid nodules, there is still geographical variation in the application of the different techniques. In a recent survey carried out by CIRSE, of 242 participants, only 63 stated that they usually perform thermal ablation for thyroid, and only 19.5% of the sample treats micropapillary thyroid tumours.
The best question or comment was from a young participant: “but who decides on the treatment of a cancer patient, the oncologist, the surgeon, the radiotherapist or the interventional radiologist?” This, I felt was especially pertinent as it was asked without any preconceptions, and it best reflects the need for this kind of course.
In 2020, the European Thyroid Association (ETA) published the first ‘Clinical practice guideline for the use of image-guided ablation in benign thyroid nodules’ in the European Thyroid Journal In 2021, the ETA and Cardiovascular and Interventional Radiological Society of Europe’s (CIRSE) ‘2021 Clinical practice guideline for the use of minimally invasive treatments in malignant thyroid lesions’ was published in the same journal.
“We are very excited about the safety and efficacy results of our HCC study in which we have been using QuiremScout for the work-up and QuiremSpheres for the SIRT treatment. At the start of our study, we did not have the opportunity to use the pretreatment planning functionalities of the Q-Suite imaging
Araiit.concluded
University Medical Center Utrecht (Utrecht, The Netherlands) recently published the latest results from the HEPAR Primary study, which evaluated the safety and efficacy of Holmium-166 (Ho166; QuiremSpheres holmium-166 microspheres) selective internal radiation therapy (SIRT) for hepatocellular carcinoma (HCC) patients (Barcelona Clinic Liver Cancer stages B and C) without curative options.
The question of injection speed then arose, with the panel all agreeing that, for use of liquid embolics in general, “when you think you are being slow enough” injecting the agent of choice, “slow down”—advice which is all the more applicable with agents at the less viscose end of the spectrum, Golzarian clarified.
Gilles Soulez (Centre Hospitalier de l’Université de Montréal, Montréal, Canada) co-moderating with Golzarian, asked his for peers’ opinions on microballoon catheters for uses other than intracranial arteriovenous malformation. Sapoval asserted that “we should master balloon-guided embolization to go distally”, which, admittedly, will require “more attention” from peripheral specialists who do not yet have balloons created with their specialty in mind.
Day two of Global Embolization Oncology Symposium Technologies (GEST; 19-22 May, New York, USA) saw delegates attend a liquid embolics masterclass where faculty also demonstrated how to use some of the products referred to over the course of the presentations. These covered the advantages and limitations of using glue, ethylene vinyl alcohol (EVOH)- versus non-EVOH-based agents, and the emergence of liquid embolics for peripheral indications. Key takeaways from the session included the importance of continually polishing skills, so as to mitigate some of the difficulties that certain liquid embolics create during procedures. In addition, panel members continually circled back to the question of whether balloons indicated for neurological conditions could be repurposed to aid in peripheral procedures.
EMBOLIZATION A next
Ho166
Also from the discussion, delegates learned that with many new liquid embolic products and the potential for new indications, it remains to be seen which techniques will work best.
software (launched in September 2020),” said author, Marnix Lam (University Medical Center Utrecht, Utrecht, The Netherlands). “Looking towards the future, I strongly believe that we can achieve even better clinical outcomes by truly individualising the treatment of each patient using the entire Holmium platform. Therefore, we are currently recruiting patients in a new multicentre iHEPAR study to further demonstrate the importance of individualising SIRT in HCC using the full Holmium platform.”
Arai talked delegates through the numerous advantages of using glue embolic agents: “We can prepare glue easily and quickly”, he stated in the first instance. Other benefits of using glues include the ability to vary concentration depending on how distally you want to do the embolization. Citing the example of gastrointestinal tract bleeding, 10% glue concentration works well as it “[flows] and [flows] and [polymerises].” Likewise, Arai showed a series of animations to demonstrate how easy it is to achieve embolization of the entire arterial network, which, with coils, would require a great number of them to achieve the same outcome. A fourth advantage is that there is “no kickback with an unstable catheter” when using glue, Arai continued, before underlining how it is even suitable for use in patients with coagulopathy. There is nuance to the benefits of using glue embolics, Arai then clarified that “while it may seem as though you can control the depth you inject to, it is, in practice, not that simple. Dilution, injection speed, blood velocity and glue viscosity are among the factors that can affect how much it is possible to dictate the depth of administration.” For this reason, using glue embolics is what Arai referred to as a “oneshot game”, with the interventional radiologist unable to correct once they have injected.
He then acknowledged the balloon microcatheter technique as a means of determining more precisely where the cast ends up, and the fact that some practitioners choose to use a coil alongside it—
Embolization: Latest News
The panel were all excited to see the “[advancements]” made with balloon technologies in the neurological embolization field transferred to peripheral in the future, with adjustments made to tailor balloons to the peripheral anatomy and for use with glue and lipiodol—an improvement on the neuro balloons sometimes repurposed for these functions.
Moderator
Further questions were raised over the risks of agent fragmentation when delivered with a very small lumen microcatheter, which must be balanced with the reality that “the thicker it comes from the catheter, the quicker it will form a cast”. Embolic material “creep-back” and reflux also featured in discussion, as panellists compared notes on why this phenomenon occurs and how to mitigate its ill effects.
HEPAR PRIMARY SHOWED AN ACCEPTABLE toxicity profile and demonstrated an objective response rate of 54% (14/26 patients) at three months after mRECIST evaluation of target liver lesions.
Holmium-166 SIRT demonstrates safety and efficacy in the treatment of HCC
Similarly, you cannot exercise full control over the exact point at which the embolic stops travelling in the vessel, and in order to guard against the glue sticking in the microcatheter, it is necessary to perform the embolization quickly—but such a careful procedure is not one you would want to rush, Arai warned.
inserting said coil first and leaving the glue to harden inside
Marc Sapoval (Hôpital Européen GeorgesPompidou, Paris, France) also referred to how “many new products have come onto the market”, of which the non-EVOH-based EasyX agent (Antia Therapeutics AG) is one—he went on to illustrate in real time how the liquid embolic creates a solid cast, in the masterclass part of the session. Other new liquid agents mentioned by Sapoval in his presentation and then demonstrated later, were the “ready-to-use” GPX (Fluidx Medical), Obsidio’s Gem and Embrace (Instylla). Embrace, a hydrogel, requires a proprietary microcatheter that can sit inside an existing catheter, where Obsidio is—to panellists’ “relief”—completely catheter-agnostic and falls somewhere “between a solid and a liquid embolic”.
by reiterating that glue embolic agents have “excellent properties not found in other embolic materials”, but that in order to reap the benefits of these, it is crucial “to polish up your skills.”
When you think you are being slow enough, slow down.” step would be to study in more treatmentindividualisedplanning.”
The Liquid MasterclassEmbolicatGEST2022
GEST 2022 brings attendees up to speed on liquid embolic advancements
Jafar Golzarian (M Health Fairview University of Minnesota Medical Center, Minneapolis, USA) prefaced the first presentation from Yasuaki Arai (National Cancer Center, Tokyo, Japan) by saying that this masterclass session was set to be “the most exciting” of the meeting, which high audience numbers appeared to reflect.
September 2022 | Issue8710
The Holmium platform consists of three integrated products, QuiremScout Ho166 microspheres, QuiremSpheres Ho166 microspheres and Q-Suite imaging software, that allow healthcare professionals to select patients with confidence, deliver treatment with precision and plan and verify with accuracy, TerumoLam’scommunicated.co-authorAdriaan Moelker (Erasmus Medical Center, Rotterdam, The Netherlands) also spoke to Interventional News about why the HEPAR Primary study is important within the field of interventional oncology and beyond, what challenges
Fielding questions from the audience following the presentation, Little responded to an enquiry into whether use of antibiotics as temporary embolic agents could lead to patients developing resistance.
Instead, Little “[prunes] the area of abnormality while maintaining normal osseus blood flow.”
Little then turned to his area of specialism—genicular artery embolization (GAE)—which has the “largest evidence base to date” of all MSK embolotherapies. “We have done a lot of work looking at GAE and how we can refine the treatment,” he
To further illustrate the potential of MSK embolotherapy, Little referenced a small study of I/C to treat chronic lower back pain that had not been responsive to conservative therapy. However, given the size of the cohort, “we still have a lot more work to do”, he admitted.
Bysupplemented.wayofexample,
Next on the agenda for Little was to outline how “new” pain as a symptom to treat actually is within interventional radiology (IR)—typically, the means of assessing pain-related outcomes of treatment has been limited to the visual analogue scale. But, “what if your pain goes from a 10 to a 5?” Little asked rhetorically, “what does that mean in patients’ daily lives?” This is where minimally clinical important difference as a measure of pain outcome has a role to play—except what that looks like for GAE is, “right now, anybody’s best guess.” Hence, this should be an area of focus in the field, Little advised. An “interesting area of future research” will be “the interplay between the brain and the knee”, as “how patients view pain impacts their progress,” Little then asserted.Thepresenter summarised the scope for MSK embolotherapy’s more widespread use as “encouraging”. Recent National Institute for Health and Care Excellence (NICE) guidelines want evidence for its effectiveness, Little shared, in the form of
“randomised controlled trials [RCTs] against sham procedure or best current practice,” with more patient-reported outcomes. GENESIS 2—an RCT against sham procedure—is, therefore, a study to watch. Little sees longerterm data and multicentre studies following on from this.
Probed about whether any aspects of the study surprised him, Moelker alluded to the “limited” posttreatment pain and liver toxicity, despite the fact that, “Ho166 has a larger embolizing effect than Y90 microspheres—the number of microspheres is much higher.” As for challenges presented by their research, Moelker cited the “small” cohort and the range in liver cirrhosis severity among patients studied, meaning that it “is not easy” to draw conclusions regarding dosimetry.
To illustrate the value of the study, Moelker gave the context that HCC is a common cause of cancer death worldwide, and it is “increasing significantly in developing countries.” Conventional radioembolization with yttrium-90 (Y90)loaded microspheres to treat HCC has “several disadvantages,” he continued, reinforcing HEPAR Primary’s significance. When using Y90, Moelker exemplified, pretreatment evaluation with albumin loaded with technitium-99 (Tc99) particles does not directly mirror the behaviour of the Y90 particles, limiting how effective this pre-evaluation can be. Ho166 microspheres, however, he then explained, can be used in low doses for pretreatment evaluation to see how the high treatment dose will work in the patient. “This will allow for better individualised treatment”, added Moelker. Another advantage of using Ho166
Mark Little (Royal Berkshire NHS Foundation Trust, Reading, UK) described the emergence of, and advancement within, musculoskeletal (MSK) embolotherapy as “fast-paced” during his presentation on the trends and developments in the field, delivered at this year’s European Conference on Embolotherapy (ET; 22–25 June, Nice, France). Featuring in the meeting’s Joints session, the presentation’s take-home message was that the “signs are encouraging” when it comes to MSK embolotherapy’s integration into more mainstream practice.
Little referred to imaging from one of his own cases—medial compartment knee osteoarthritis, which “[showed] a large area of abnormal synovitis.” The approach for this patient was to cannulate the superior medial genicular artery, Little detailed, but, crucially, “to maintain the normal in-flow vessel.”
elbow, for which surgical options are limited, and adhesive capsulitis, which is increasingly prevalent as a result of the increasing prevalence of diabetes.
Mark Little
Moving on to address the scientific rationale for MSK embolotherapy, Little described how the conditions are “underpinned by [an] area of hyperaemia.” New abnormal blood vessel formation “results in the release of cytokines” followed by “[hypersensitisation] of the nerves” and “pain”.
AMONG THE OPENING statements from Little was the “[importance of agents”—“differentdiscussing]territories need different embolic agents,” he informed delegates. For osteoarthritis of the hand or tendinopathy in the foot, “you would not want a permanent embolic”, which is where the “antiquated” antibiotic imipenem, in combination with cilastatin, comes in. It acts as a temporary embolic agent, Little explained, and it has “rapidly emerging potential.”Forexample, for plantar fasciitis, which is “really difficult to treat” and “extremely painful”, imipenem/ cilastatin (I/C) can be injected into the posterior tibial artery, resulting in reduced pain and plantar fascia thickness. Sports medicine, Little went on, is “a real growth area” for MSK embolotherapy, as hyperaemia that cannot be treated conservatively may be resolved with agents such as I/C. However, a current limitation, Little acknowledged, is the fact that I/C is not approved for embolotherapy in many countries, and the UK and USA are not among those where approval is granted.Nevertheless, Little conveyed the significance of the fact that MSK embolotherapy has the potential to treat “a breadth of conditions,” listing tennis
microspheres over Y90, he elaborated, is that “they can be quantified with MRI, which can be carried out intra-operatively.”
Embolization: Latest News
and surprises the study presented, and the team’s next steps research-wise regarding radioembolization for HCC with Ho166.
Then responding to a final question of where his team’s research into Ho166 microspheres will lead, Moelker opined that a “next step would be to study Ho166 in more individualised treatment planning and investigate the effect of treatment with the maximum safely achievable dose”—the HEPAR Primary study, as Moelker stated, did not use doses higher than 60Gy.
Issue87 | September 2022 11
“A good question—I have no idea”, Little admitted, going on to say “one would intuitively think, yes.” He then acknowledged that the main issue with antibiotics for this indication is the “East/West divide”—“we [in the UK] are very much limited”, as a result of the temporary agent I/C’s lack of Aavailability.follow-up question on his preferred embolic material saw Little state that the MSK community is “crying out for imipenem” and all of its “mystical, magical properties” when it comes to treating hands and feet. For knees, he continued, “there are good data for permanent embolics”.
Objective response rate at three months (14/2654patients)%
Different territories need different embolic agents.”
ET gives airtime to the momentum behind MSK embolotherapy
Measuring pain in IR
This is “very different” to the endpoint for prostate arterial embolization—“we are not wanting to completely block the in-flow vessel”, the result of which could be necrosis.
Coils were the most popular means of embolization
“Weinjury.allwant to avoid clamshell thoracotomy for haemorrhage,” Low stated, proceeding to explain that “it is difficult and stressful for surgeons and awful for patients in terms of mortality and morbidity.” Low then moved on to describe the role of an IR in a case of a patient who had sustained a chest wall laceration, emphasising the time-saving advantage of embolizing with small coils. It took 20 minutes from the point of the initial aortogram, she recounted, adding that it would be “difficult for a surgeon to achieve haemostasis in that time.”
Then addressing the question of proximal or distal embolization, Van Delden acknowledged that “there is no consensus” on which is best, and that it can be down to IRs’ preferences as individuals and “multiple different
“Tortuosityvariables.”ofvessels”
A further learning point from Low’s presentation was that it is “important to interrogate multiple vessels as there are often collaterals/secondary bleeding points”—it is not enough just to address the bleeding that you see initially.
LowDeborah
With regard to embolic agent choice, Low echoed Van Delden by confirming with audience participation that “many of the well known embolics would be feasible,” for treating the thoracic injuries which formed the basis for her presentation. “We tend to use coils—they are relatively easy and quick to deploy,” she said, supplementing her previous statement.
Following Low’s presentation, the question arose on how the vital service IRs can provide in trauma settings, with knife crime rates rising, is reflected in the rota at the Royal London. Low responded that she is on call one night in eight; this is, however, not typical, particularly in smaller IR centres.
feature of this session overall was audience interaction; with each case presented, the speaker posed the question to the floor of whether to embolize and, if so, which agent to use, to the floor, before commenting on how closely the consensus from the room aligned with their preferences and choice in the real-life scenario about which they were speaking.Van Delden’s presentation gave him opportunity to convey his feeling that “blush” on a computed tomography (CT) image— indicative of vascular injury—is not a solely sufficient reason for embolizing, but that when it does not “resolve itself”, and the IR has also taken into account “age, coagulopathy and fragility”, it can be a good approach.Inboth the cases Van Delden put to the audience, opinion was split down the middle on whether or not to embolize, highlighting the multifaceted decision-making process involved in intervening in these trauma situations. Van Delden summarised for the audience that, if they themselves are faced with the question of whether or not to embolize, the factors to consider are the extent of organ injury, haemoperitoneum, and vascular lesions, which can be seen on CT. Expanding on this, Van Delden listed some of the vascular lesions, in the presence of which, embolization may be indicated: active extravasation outside or within the organ, and false aneurysm. If high-grade organ injury or enlarging haemoperitoneum show on a CT scan, then these are “predictors” of an embolization, Van Delden also noted.
September 2022 | Issue8712 EMBOLIZATION
ET presenters explain use of embolic agents and techniques in trauma settings
Anoteworthy
Speaking alongside Van Delden in the trauma
In a similar vein, the question of how quickly IRs are expected to get to an on-call case in turn raised the issue of the prohibitive cost of living within the requisite 30 minutes from the hospital. Low acknowledged that “some staff, due to this, live a way out of London”. In reality, therefore, there is often an hour’s leeway by the time a patient is in the department, ready for a procedure.
and “time pressure” also come into embolization-related decisions, the presenter added, reinforcing his earlier point that embolization for trauma can divide opinion and resist consensus. “Although coils are the mainstay for treating liver injury,” a little over the majority of voting delegates would have chosen a gelfoam agent in the instance shown on screen by Van Delden, who conceded that depending on coagulopathy, a non-coil embolization may be more suitable.
However, having discussed the role IRs have to play in these trauma situations, Low made clear to delegates that there are limits to where interventional radiology can be of benefit, depending on the case. She provided an example of an elderly patient with a mitral valve replacement and what appeared to be a large pleural effusion. A drain inserted into this drained frank blood. The learning point being that if you insert a drain and what drains is unexpected, leave it, possibly clamp it and consider imaging to assess. Sometimes surgery is the only option!
We tend to use coils they are relatively easy and quick to deploy.”
session, Deborah Low (The Royal London Hospital, London, UK) began her presentation on acute thoracic bleeding by putting delegates in the picture regarding her role at one of the UK’s major trauma centres. The Royal London Hospital takes trauma patients in from a wide geographical area and also via air ambulance. Increasingly, knife crime can be a significant cause of these acute hospitalisations. Providing additional context, the presenter noted that “thoracic injury accounts for 25% of trauma-related mortality and contributes to a further 25%,” which is often linked to lung
Speaking to Interventional News after the session, Low drew out what she considered to be one of the most crucial learning points from it—the key to successful management of trauma patients is “availability, speed, most of all communication with surgeons,” underlining how good IR-trauma surgeon relationships can go a long way towards optimising trauma interventions for the patient’s benefit.
As part of the ‘Trauma and Emergencies’ session at this year’s European Conference on Embolotherapy (ET; 22–25 June, Nice, France), conference deputy chairman Otto van Delden (Amsterdam University Medical Centers, Amsterdam, The Netherlands) presented blunt abdominal trauma cases to delegates “to underscore the teaching points” that these types of clinical scenarios offer. In the course of his presentation, he addressed key questions an interventional radiologist (IR) may have regarding the treatment of blunt abdominal trauma, including “which embolic agent and technique [you should] choose for the most frequently encountered injuries.”
Embolization: Latest News
Otto Deldenvan
among audience members for the cases Van Delden presented, with 71% of the vote for the splenic injury case, which was one of those detailed by the presenter. Although coils may be a favoured choice, “you need to choose the size carefully,” Van Delden cautioned, as it is essential not to occlude too much vessel, nor to have the coil move within it.
liquid embolic has tremendous potential to play an important therapeutic role in a wide variety of clinical applications including haemorrhage and interventional oncology,” commented Gandras, the lead author of the study.
“GPX IS DEMONSTRATING deep distal vessel penetration,” said Ryan O’Hara, interventional oncologist at the University of Utah (Salt Lake City, USA). “The ability to fill the smallest tumour-feeding vessels and reach distal vessel beds is very important in effective treatment of hypervascular tumours and in other embolic procedures.”
New embolic demonstratesdevicesuperior vessel filling in tumour models
not observed with 40-micron microspheres.”GPXandmicrospheres were studied in selected small branches of renal arteries. The GPX embolic device filled vessels more completely and penetrated deeper into smaller vessel beds than the microspheres commonly used for tumour treatments.
Instylla announces positive results from preclinical studies of Embrace hydrogel embolic system in haemorrhage models
Instylla, a company developing liquid embolics for peripheral vascular embolotherapy, has shared two publications that evaluated the Embrace hydrogel embolic system (HES) in preclinical porcine haemorrhage models.
Fluidx Medical disclosed study results examining extent of vessel filling using the GPX embolic device compared to microspheres, a common treatment for many types of tumours.
“GPX exhibited effective and thorough embolization throughout the renal cortical vasculature,” according to an assessment conducted by study pathologist James Stanley. “GPX filled the smallest arterioles of the distal cortex which was
The ability to fill the smallest tumourfeeding vessels [...is] important in effective treatment tumours.”hypervascularof
13Issue87 | August 2022 Embolization: Latest News
Embolizing blood supply is a high-growth procedure to block said blood supply to certain tumours. Transarterial chemoembolization (TACE) includes delivering chemotherapy with embolization. Tumour embolization may also be performed prior to resection.
In an independent study conducted by Kauvar et al, splenic injury and resulting haemorrhage were induced in swine models. A comparison was made between a control group having no embolic treatment to treatment groups that received embolization with Embrace HES, gel foam slurry, or coils. Under coagulopathic conditions, Embrace HES showed improved survival time and a significant reduction in bleeding compared to the control group, gel foam slurry, and coil treatments.
IN A JOURNAL OF VASCULAR and Interventional Radiology (JVIR) publication, Eric Gandras, associate chief of vascular and interventional radiology at North Shore University Hospital, (Manhasset, USA) et al evaluated the ability of Embrace HES to achieve haemostasis in a porcine mesenteric artery haemorrhage model that replicates injury in humans. Results demonstrated that Embrace HES achieved complete, rapid, and durable embolization in 100% of the injured arteries with a mean delivery time of 5.3 minutes. There was no angiographic evidence of non-target embolization.“Embracewas effective in achieving haemostasis in an animal haemorrhage model without evidence of non-target embolization. This next generation
The authors also underline the importance of the IASIOS accreditation from the point of view of the IO patient, who often does not receive follow-up from the interventional oncologist who has carried our their procedure. By “[encouraging] interventional oncologists to work as fully-fledged clinicians who take primary responsibility for their patients”, the authors hope that patients treated in a centre with this accreditation will experience more streamlined and timely care.
The International Accreditation System for Interventional Oncology Services (IASIOS) was launched in April 2021. In May 2022, Sonam Tashi, Sivanathan Chandramohan and Bien-Soo Tan from the Division of Radiological Sciences at Singapore General Hospital (Singapore), and Andreas Adam (King’s College London, London, UK) published their article ‘Accreditation in interventional radiology: Why it matters and why we sought IASIOS certification’ in CardioVascular and Interventional Radiology (CVIR). The article discusses why accreditation for interventional radiology (IR) centres is important, the benefits it brings for staff and patients, and anecdotal experience from the Singapore General Hospital following its participation in the IASIOS pilot programme from 2018, and the eventual receipt of accreditation in May 2021.
Researchers at Emory University treated eight patients with chronic
T
All patients participating in the study returned to their baseline strength over time. In six of the eight patients, pain symptoms dramatically improved following regeneration— reflected as a collective decrease of 4.6 points in Visual Analogue Scale pain“Wescores.areusing this regeneration technique not only to manage nerve pain induced by trauma—but also for pudendal neuralgia, post-mastectomy pain, post-surgical pain, and other conditions historically managed with narcotics,” says Prologo.
The diagnostic examination known as selective salpingography showed that nearly one in four (23.8%) had been mistakenly told they had one or both fallopian tubes blocked. Of those with a blockage, over half (56.7%) were unblocked using a fine wire in the fallopian recanalisation process, researchers said. In summary, 80.5% of women in the study who had previously been told they had tubal blockages left the same day with both fallopian tubes open after a simple outpatient procedure.Machan said the research suggests that selective salpingography should be offered more broadly in assessing and treating female infertility. “Fertility treatments can be expensive and out of reach for many women,” he said. “Infertility is also an emotional, often heart-breaking journey, so having this procedurediagnosticandtreatmentavailablecouldbe life-changing.”
Asked by Interventional News in an interview about the impact accreditation has had on IR services at their centre,
New Data from SIR I am now safetycognisantmoreoftheaspectofmywork.”
Chandramohan gave the following response: “Even though IASIOS only covers the IO [interventional oncology] framework, the principles apply to wider IR work. We do other interventions including dialysis access and vascular interventions, and are able apply the same principles of patient and staff safety, multidisciplinary team discussions, and use of the most upto-date equipment to these areas too.” Chandramohan also asserted that he, personally, is now “more cognisant of the safety aspect of [his] work.”
“Interventional radiologists can place these needles safely in precise locations all over the body, allowing access to pain generators that were previously unreachable and giving hope to patients who struggle with pain.”
nerve pain related to a prior trauma with computed tomography (CT)guided interventional cryoneurolysis. This technique uses imaging to place a needle and freeze damaged nerves, causing them to degenerate and lose function. “What happens next is almost magical,” Prologo says. “If the nerve is exposed to the correct amount of cold, over the correct area, for the right amount of time, it will replace the previously damaged nerve with a healthy one.”
J PrologoDavid
Damaged nerves can be regenerated with the application of a frozen needle under advanced imaging guidance, according to new research presented at the Society of Interventional Radiology Annual Scientific Meeting (SIR; 11–16 June, Boston, USA). The technique, called cryoneurolysis,interventionalcanoffer hope to patients in persistent pain following a traumatic injury.
Minimally invasive treatment could allow more women to conceive without fertility procedures
“THIS PROCEDURE AND treatment can help women make an informed decision about infertility treatments. And for many, it can actually give them the chance to conceive naturally,” said Lindsay Machan (University of British Columbia, Vancouver, Canada), a lead author of the Researchersstudy.atthe University of British Columbia Hospital (Vancouver, Canada) studied cases from 2015 to 2021 involving 956 women with infertility who had previously been diagnosed as having one or both fallopian tubes blocked based on the standard diagnostic procedure used to assess the openness of fallopian tubes, known as underwent(HSG).hysterosalpingogramThewomenthenaselective salpingography to confirm their HSG diagnosis and, if recanalisation.fallopianunderwentneeded,tube
New study cites managementintreatmentbreakthroughpossiblepain
A simple diagnostic procedure, followed by an interventional radiology treatment known as fallopian tube recanalisation, could allow a high percentage of women struggling with infertility from blocked fallopian tubes to conceive with less involved or, in some cases, no further invasive fertility procedures, according to new research, which was presented at the Society of Interventional Radiology Annual Scientific Meeting (SIR; 11–16 June, Boston, USA).
MachanLindsay
he authors begin their article by acknowledging that the process of obtaining accreditation is often seen to be “onerous and resourceintensive”, but that, as far as research shows, this undertaking pays off, to continually improve patient safety, a hospital’s culture and its efficiency through standardisation. The institution in question also stands to gain in terms of performance, including clinically.
In addition, Chandramohan highlighted to Interventional News that the IASIOS accreditation has meant he is “seeing more patients in the clinic than before, as we encourage our oncology colleagues to send the patients to our clinics for discussion about interventional treatment, rather than just requesting a procedure to be done on the patients—we are treated less like technicians.”
The article’s authors proceed to advise that any healthcare institution looking to achieve this accreditation—”the first attempt by any professional organisation to create a scheme that covers all aspects of professional practice in IO”, the authors note— consider first how demanding the criteria for doing so are, so as to foster improved performance, rather than impeding it.
September 2022 | Issue8714
Singapore General Hospital authors speak to benefits of seeking IASIOS accreditation
“THE IDEA THAT WE CAN induce regeneration of damaged nerves simply by placing a cold needle through the skin under imaging guidance is extremely exciting,” said the study’s lead author J David Prologo (Emory University School of Medicine, Atlanta, USA). “This research answers the call from US legislators and specialty medical societies to develop alternatives to opioids for the management of pain.”
There is no doubt that good dosimetry starts with a good angiographic work-up […]”
flow distribution in the entire target liver volume.Thecapacity of the arterial branches to receive the right quantity of spheres is another matter of concern, particularly in tumours with multiple feeding vessels and in pre-treated patients with impaired arterial vascularisation. Minor tumour-feeding vessels may require coil embolization to promote flow redistribution. However, redistribution requires an in-depth knowledge of the possible intra- and extrahepatic arterial connections; it may be tricky
Comment & Analysis
The rebirth of
trials (RCTs), transarterial radioembolization (TARE) is finally back in the spotlight. And interventional radiologists (IRs) are learning from these past failures to shape the future.
Learning from the past, the current decade has finally started with successful trials, showing the efficacy and safety of TARE in primary tumours (such as the DOSISPHERE-01 [Boston Scientific], TRACE and LEGACY [Boston Scientific] trials for hepatocellular carcinoma (HCC) in advanced, intermediate and early stages, respectively) as well as metastatic lesions (such as the EPOCH [Boston Scientific] study in second-line colorectal cancer metastases).
AftercrucialradioembolizationtransarterialandtheroleoftheIRthedisappointmentofafewfailedrandomisedcontrolled
and the American Society Nephrology ing new race-free approach to diagEpidemiology Collaboration (CKD-EPI) T American Journal of Kidney Diseases (AJKD) equity,” said NKF president Paul Palevsky. “We commend to eliminate disparities the diagnosis and treatment of involved providing recommendations based this. Bioarti cial device preclinicalafterKidneyXreceivesawardreachingtesting in preclinical model following successpreclinical testing and, eventually, clinient technologies included wearable, light“The NKF and ASN urge all laboratories and healthcare systems nationwide to adopt this new approach as rapidly as possible so that we can move diagnosing kidney diseases that is independent of race.” Paul Palevsky Renal reckonscommunitywithremoval of race variable in kidney disease diagnosis Sign up for a free print subscription* and e-newsletter subscription** atRenalwww.renalinterventions.netInterventions is a specialised news source in the field of renal disease management. *Available for US and EU readers only ** Available worldwide
There is no doubt that good dosimetry starts with a good angiographic workup, by understanding anatomy, flow distribution and haemodynamics, so that the tumour can be targeted selectively.
main challenge was the identification of extrahepatic vessels, we are moving towards selective and super-selective treatments and, where these are not possible, we are learning how to exploit and modify the arterial flow.
Irene Bargellini
Disclosures: Bargellini declared having received an institutional research grant from Boston Scientific; consulting fees from AstraZeneca, EISAI, GE Healthcare, Guerbet, Merck, Sirtex, Terumo; honoraria for lectures from AstraZeneca, Bayer, Boston Scientific, Eisai, Guerbet, Merck, Sirtex, Sobi, Terumo; having been part of the Independent Data Safety Monitoring Board for AstraZeneca.
without harming the surrounding liver parenchyma. With high tumour-absorbed doses, complete tumour necrosis may be achieved, translating into a durable response, conversion to surgery and ultimately significant survival advantage. However, obtaining a high tumour-absorbed dose implies limited dose to the non-tumoral parenchyma— in other words, a high tumour-to-liver ratio. If all or almost all the activity is
Over the years, the preliminary angiographic work-up has adapted to increasingly refined dosimetry calculations. From whole-liver and hemi-liver treatments, in which the
and unpredictable, varying by specific vascular anatomy, the tumour type and tumour location. The success of flow redistribution has been reported to be lower in certain conditions, such as when parasitised arteries are embolized proximally, or when it is difficult to predict which vessels are going to be recruited after embolization— in centrally located tumours if unilobar treatment is planned, and in hypervascular bulky lesions. As a result, flow redistribution is now recommended only when strictly needed.
September 2022 | Issue8716 Comment & Analysis
DESPITE NEGATIVE RESULTS, former trials have taught us that TARE is a highly effective treatment option if some essential rules are respected. Firstly, thoughtful selection of patients, with careful evaluation of the liver function reserve. Secondly, adequate arterial vascularisation, with a preference for no harm caused by prior therapy. The third rule is to carry out personalised dosimetry tailored to the vascular anatomy, tumour type and extension, the patient’s characteristics and the goal of treatment.
While selectivity can be relativity easy to obtain when dealing with hypervascular lesions, and well demarcated and limited tumour burden, it becomes challenging in patients with infiltrative lesions, hypovascular tumours and multifocal extensive disease. How can we obtain a selective intratumoral concentration of particles in theseSeveralcases?computational studies have shown that even minimal modifications in injection parameters and position, shape and orientation of the supporting catheters and of the microcatheters may have a meaningful impact on the distribution of flow in the target volume. As an example, when the catheter is close to an arterial bifurcation, a preferential flow into one of the two branches is frequently observed, influenced by the size of the distal vessels, their area of distribution, and the morphology and the orientation of the catheter’s tip. The challenge for the operator is to select the most appropriate position for the catheters and, if needed, exploit specific pre-shaped microcatheters, to obtain a homogeneous
Personalised dosimetry has become a central focus of investigation in an attempt to identify the most adequate administered activity for achieving tumoricidal tumour-absorbed doses
concentrated selectively in the tumour cells, there is, potentially, no limit to the radioactivity level we could administer! But what do IRs have to do with this?
Specific microcatheters, such balloon and anti-reflux microcatheters, have recently become available, and through different mechanisms, they are able to modify the haemodynamics and flow distribution, potentially enhancing the intratumoral uptake and reducing the risk of reflux and nontarget embolization. These tools may be of particularly useful for treating hypovascular lesions and multifocal disease. How effective they are for radioembolization is still being investigated.Inconclusion, we have learned over the years that, to be successful, radioembolization requires a high level of expertise—it is a truly multidisciplinary treatment modality. Dosimetry is key to success; yet, personalised dosimetry requires personalised angiographic planning based on flow analyses and where possible, flow modification, to achieve selective tumour uptake.
Irene Bargellini works within the Division of Vascular and Interventional Radiology at Florence University Hospital (Florence, Italy).
Bela KieranKisMurphy
Kis concluded that first-line treatment of IHC with radioembolization is promising from an OS and toxicity standpoint. When compared to published data on IHC, radioembolization appears to be at least as effective as systemic chemotherapy, but with a much better toxicity profile. This prospective trial suggests that radioembolization can be considered a firstline treatment for unresectable IHC.
At the Society of Interventional Radiology (SIR) 2022 Annual Meeting (11–16 June, Boston, USA), four of the abstracts submitted were declared ‘Abstract of the Year’ by the society scientific chairs. The prizes were conferred during the final plenary session of the meeting, and, according to SIR, reward the ‘best scientific work’ in terms of ‘overall quality, timeliness and content’. ‘The Best of GEST’ session on the penultimate day of the Global Embolization Oncology Symposium Technologies meeting (19–22 May, New York, USA) also saw prizes awarded to the best scientific abstract presentations.
Best Abstracts
Erica Emmons
GEST winners: PAE and protein hydrogel
Authors receive accolades for best abstracts at SIR and GEST
able to avoid having further surgery.
‘RadioembolizationThisprospectiveresultsmesothelioma—interimofaphasetwostudy’.year,hewonwith
with Y90 glass microspheres as first-line treatment for phase(IHC)—acholangiocarcinomaintrahepaticunresectableprospectivetwoclinicaltrial’.
that are associated with RE response. RE was found to be associated with immune activation, as seen within the tumour microenvironment and peripherally. The results also suggest that peripheral markers of inflammation, including monocytes, may indicate a poor response to RE.
Twenty-five eligible patients were enrolled in Kis’ institutional review boardapproved phase two study and the primary endpoint was progression-free survival (PFS) and secondary endpoints, OS and toxicity. Two patients were excluded from the study on the basis of unrecognised lung metastasis at the time of Y90 treatment, and right hepatectomy four weeks after Y90, respectively. Twelve women and 11 men were included, of whom the median age was 76 years.
The study was carried out across three European hospital spine centres in 49 patients with a mean age of 40, of whom 17 were females and 32 males. All had a single-level contained lumbar disc herniation and had been experiencing radicular leg pain for more than six weeks, as well as being resistant to medical management.Theprimary outcome was overall six-month improvement in leg pain, compared to baseline. Secondary outcomes included back numerical rating pain scores (NRS), Roland Morris Disability Index (RMDI) scores and EuroQol (EQ)-5D, which were collected at baseline, one week, and one, three and six months. Both treatments resulted in rapid and statistically significant improvements over baseline in leg pain, back pain, RMDI, and EQ-5D that persisted in follow-up, and no outcome differences were statistically significant between the two groups.
The aim of his study, Sapoval outlined for delegates, was to “obtain prospective long-term results” from the USA, UK, Italy and France, where some of the participating centres were also located. Using 300–500-micron embospheres, Sapoval described how cone beam computed tomography (CT), followed by Francisco Carnevale’s PErFecTED technique (Proximal Embolization First, Then, Embolize Distal) was implemented, where possible. The first step was to carry out a proximal embolization, before taking it more distally, using an embolic agent up to total occlusion of the prostatic artery.
Amy Deipolyi (Charleston Area Medical Center, Charleston, USA) was another presenter whose abstract ‘Immune activation markers and response to radioembolization of breast cancer liver metastasis: Pilot study’ won the prize. Her purpose in carrying out the study was to ascertain whether radioembolization (RE) of breast cancer liver metastasis (BCLM) activates immune function, as well as to identify the markers of immune function
Kieran Murphy (Toronto Western Hospital, Toronto, Canada) also won the award, for his report on a noninferiority, prospective, randomised controlled trial (RCT), which compared intradiscal oxygen-ozone chemonucleolysis to microdiscectomy for lumbar disc herniation radiculopathy.
‘In vitro evaluation of novel protein hydrogel microspheres for transcatheter embolization’ was the second-prize-winning abstract from Chen Guo (University of Minnesota, Minneapolis, USA). She began her presentation by explaining how “in vitro experiments where cells were cultured on the surface of whey protein-based biomaterials, like a scaffold” demonstrated how its ability to “support cell attachment and growth” makes it a good embolic agent. Not only this, but its ready availability as the waste product in cheesemaking, as well as whey protein’s natural biocompatibility and biodegradability, and low immunogenicity, enhance its potential as a building block of a new type of embolic microsphere.Furthermore, Guo spoke to the drugloading capacity of whey protein—its carboxyl groups are “easy to modify” and “negatively charged [meaning you can] load them with positively charged drugs”.
Marc Sapoval (Hôpital Européen Georges-Pompidou, Paris, France) was announced as winner at GEST for his ‘One-year results of a prospective multicentric cohort study on prostate arterial embolization’. Chen Guo’s study of whey protein’s potential as an embolic agent earned her second place.
The study was carried out on 478 patients, who were monitored between December 2018 and December 2019. “Four hundred and five of these patients underwent PAE for bothersome lower urinary tract symptoms [LUTS], and 73 for an indwelling bladder catheter” Sapoval averred, however, only 2.1% of participants were recorded to have experienced serious adverse events (SAEs).
Murphy’s conclusion is that intradiscal oxygenozone chemonucleolysis for single-level lumbar disc herniations that are unresponsive to medical management, met the non-inferiority criteria to microdiscectomy on six-month mean leg pain improvement. The study also found that 71% of patients who were randomised to the oxygen-ozone group were
Marc Sapoval
E
There was variation in whether Y90 was used as part of first-line therapy (17%), second-line therapy (41%) and thirdline or beyond in 43% of patients. Fourteen per cent of patients had undergone hepatic resections before treatment with Y90, another 14% had received ablation, 6%, and 2% of patients had undergone portal vein embolization.Emmons’and her co-authors’ conclusion is that Y90 resin microsphere embolization contributed to 15 months’ overall survival (OS) after treatment, with patients with the longest OS having received the treatment as part of second-line therapy.
The patients received a median dose of 136Gy radiation from the Y90 treatment. Median PFS was 5.5 months (95% confidence interval [CI]: 3.9–7.1 months). Median OS was 27.2 months (95% CI: 8.5–4.9 months) from diagnosis and 19.4 months (95% CI: 4.6–34.1 months) from Y90 treatment.
Amy ChenDeipolyiGuo
Y90
Among the cohort studied, there was improvement in quality of life, with a low reintervention rate. This, Sapoval contextualised, highlighting how it “[compares] favourably with [existing] literature”. Moreover, nearly two thirds of patients referred for an indwelling catheter were catheter-free at long-term follow-up. Therefore, it is possible to draw the conclusion that “across multiple centres in Europe and the USA, [PAE] is safe and effective.”
SIR radioembolizationrewards research
after15contributedembolizationmicrosphereresintomonths’OStreatment.”
The patients on whom Emmons et al’s study reports were treated from 2015–2020 and the cohort was 40% female (n=200) and 60% male (n=298). The median age was 60 years old.
Issue87 | September 2022 17
Guo noted that upon testing the microspheres for suspensibility, they performed equally well, “[suspending quickly]” in comparison to embospheres. Overall, the evaluation yielded the conclusion that whey protein has “great potential for embolization” and provides “a valuable platform for further modification.”
rica Emmons (Vanderbilt University Medical Center, Nashville, USA) was one of the winners, for her paper ‘Survival outcomes and toxicities following yttrium-90 (Y90) radioembolization of colorectal cancer metastatic to the liver: 498-patient analysis from the RESiN registry.’ The outcomes measured were treatment characteristics, survival, and safety.
Bela Kis (Moffitt Cancer Center, Tampa, USA) received the prize for the second time in three years. In 2020, his winning abstract was ‘Transarterial chemoperfusion treatment of unresectable pleural
ractice patterns and data from around the world were brought to delegates via special sessions from the USA, with CiDA@EVA (Controversies in Dialysis Access); the Middle East with PAIRS@EVA (Pan Arab Interventional Radiology Society); and the Asia Pacific with DASy@EVA (Dialysis Access Synergy). Important developments in transplantation— such as organ utilisation strategies and xenotransplantation—and home haemodialysis (HHD), both of which often sit outside the traditional realm of vascular access but raise important questions on how best to manage patients with end-stage kidney disease (ESKD), were also in focus.
Catheter arms race and modulating mega fistulas
EVA course directors (left to right): Dimitrios Karnabatidis, Panagiotis Kitrou and Konstantinos Katsanos
Robert Jones (Queen Elizabeth Hospital, Birmingham, UK), president of the Vascular Access Society of Britain and Ireland (VASBI), asserted that, while all eyes are on percutaneously created fistulas, there are still significant untapped areas for research and education in endoAVF.
in endpoint definitions are abundant in the literature, Jones also warned. “I think there does need to be some consistency with definitions moving forward, so we can make meaningful comparisons between all these different studies.” He called for more focus on cannulation as “that is what is important to
Lively discussion on unmet needs and building on quiet developments in vascular access from leading surgeons, interventional radiologists, nephrologists and interventional nephrologists formed the backbone of the recent EndoVascular Access (EVA; 24–25 June, Patras, Greece) meeting’s programme.
EVA meeting harnesses global, expertsmultidisciplinaryandanalysisto guide the way in vascular access
Ziv Haskal (University of Virginia, Charlottesville, USA) alluded to the 20-year arms race of catheters and emphasis on “larger and larger sizes, and coatings”, which have never been tested in headto-head comparisons to show improvements. “And, yet, we are still focusing on those,” he said, calling for a shake-up in thinking. Turning tack to balloon maturation, he pointed out that interventionists would do well to enhance their understanding of what it takes to get a fistula to mature—whether it is created by surgical or percutaneous means—and not simply use balloon angioplasty as a go-to procedure.
Untapped research areas for endoAVF
Ziv Haskal
Scott Trerotola
create, maintain or make larger, there are important examples of unmet needs, such as the long-term cardiovascular consequences of high-flow fistulas,” Haskal added. “We know annual cardiovascular mortality is so very great in these patients. And, we need technology to be able to modulate those mega fistulas. On the other side is the systemic atherosclerosis; the extraordinary peripheral arterial disease and critical limb ischaemia that we must provide care of. We need defined approaches that are unique to this population and to keep this in everyone’s minds.”
“I wanted to highlight that, outside of our narrow tunnel vision of the pipe, which we have to either
P
Trerotola told Interventional News: “Again, you may not be able to compare these different studies, but if you can get good angioplasty, why not do it?” The theme of “good” high-pressure balloon angioplasty was further examined in light of the PAVE trial, which did not show a significant benefit with DCB use as high-pressure balloon angioplasty results were unexpectedly robust. PAVE principal investigator Narayan Karunanithy (Guy’s and St Thomas’ NHS Foundation Trust, London, UK) noted that “good” high-pressure balloon angioplasty for failing access circuits could make all the difference. “One of the strengths of PAVE is that it had independent adjudication of results by ultrasound. The idea that high-pressure balloon angioplasty for dysfunctional dialysis access circuits is a good first approach, followed by DCB, and covered stents can be reserved for bailout situations in cases where evidence is missing, might be worth exploring,” mused Kitrou.
“There are a whole host of new procedures on the horizon, such as the percutaneous creation of arteriovenous fistulas [AVFs], including those that are precision-guided. The EVA programme aimed to go beyond traditional silos in terms of specialities and topics to examine [them] from an evidence-based perspective, as they affect our understanding and management of vascular access patients. This was truly a broad-spectrum vascular access meeting with a global faculty,” EVA course directors Dimitrios Karnabaditis, Konstantinos Katsanos and Panagiotis Kitrou (all University of Patras, Patras, Greece), told Interventional News
RENAL
“Patient selection is a great example,” he said, noting that most of the focus to date in this area has been on vessel mapping and size criteria, and the presence of the perforator.
September 2022 | Issue8718 Vascular Access
The war on access dysfunction using drugs
the patient”. “Ultimately, they are the end user and, whilst we talk about the scientific side of things, there needs to be more focus, understanding and education around cannulation,” he added.
Elsewhere, Katsanos provided a whirlwind tour of increasing interest in the limus family of drugs, describing them as a “large group of rapamycin analogues that are cytostatic, rather than cytotoxic, which paclitaxel is”. He noted that limus drugs offer a potential alternative to paclitaxel due to their wider therapeutic margin and mode of action. “There is a large family of ‘rapalogs’ already widely effective and used in coronary artery disease. Two randomised controlled trials of sirolimus-coated balloons in the treatment of AVF stenoses are currently underway with two different platforms using different doses of sirolimus,” he concluded.
Robert Jones
ROUND UP
“More understanding of whether predialysis patients or those already on dialysis will benefit the most from endoAVF is another good example, as is recognising recent studies in surgical fistulas that have demonstrated major differences in fistula use and success between ethnic groups,” he pointed out. “We do not have these data forInconsistenciesendoAVF.”
While the safety and efficacy of drug-coated balloons (DCBs) in dialysis access is increasingly being backed by mid-to-long-term evidence, Haskal recently warned against “optimistic overexuberance” in an interview with Renal Interventions. At EVA, he spoke on the benefits of getting data from industry trials with tight populations and controlled situations, but asked Scott Trerotola (University of Pennsylvania, Philadelphia, USA): “How do you compare these populations one to the other when they all live like these beautiful, independent Greek islands? Can you take the group from one and case control into another, and then draw conclusions?”Trerotolainitially qualified by saying a biostatistician would likely answer with an “absolute no”, adding: “When you have a whole bunch of studies that have been done exactly the same way, and have the exact same signal—for example, the control groups in all of these DCB studies remarkably show the same outcomes in terms of primary patency […] maybe we are really onto something.”
Key trial updates were presented, including on the Ellipsys vascular access system (Medtronic), the AVENEW study (BD), first clinical experiences with the Wrapsody endoprosthesis (Merit), and the EVA DROP study. The latest research—for example, on how ‘omics’-based analysis could optimise central venous stenosis treatment—and new technologies, such as a remote monitoring system providing continuous haemodialysis access data (Alio), were also discussed.
Robust as opposed to real-world angioplasty Comparisons across studies that used different device types clearly pose an additional challenge and might even be entirely unscientific, said Trerotola. “Still, one of the things that has perplexed me is, if you look at the control arm of the AVENEW study, the results of plain-balloon angioplasty are really quite poor. They are much lower in terms of patency than all of the control arms in these DCB trials. Why? Well, if you ask principal investigator Bart Dolmatch [Palo Alto Medical Foundation, Mountain View, USA], he will tell you it is because they did not perform the same kind of angioplasty.” At EVA, Trerotola noted that some have deemed this “real-world” angioplasty, to which he countered: “Not in my world.”
The presenter commented that, though the data come with some limitations, they are “encouraging” and show for the first time patients with a higher time in target range have reduced events.
Flex Vessel Prep system shows favourable six-month results compared to historical data
T
The FLEX AV registry sixmonth PTAoverarchinimpressivepatientsacrosssustaineddemonstrateoutcomespatencymostandreallyresultsthecephalicandAVGstreatingwithalone.”
reported RADIANCE-HTN SOLO (conducted in patients with mild-to-moderate hypertension) and TRIO (conducted in those who remained hypertensive despite being on antihypertensive therapy). Both studies met their primary effectiveness endpoints.
Renal denervation shows promise as an adjunctive therapy ReCorhypertensionforMedicalandOtsukaMedical
A patency of 71% for all AVF patients—219 days FFTLR, compared with historical data ranging from 21.3 to 55%
The six-month safety and patency results for African American patients treated with Flex Vessel Prep were equal to or better than the total patient pool for all recorded measurements.
enrolled were African American.
Devices have announced that the RADIANCE II US Food and Drug Administration (FDA) investigational device exemption (IDE) pivotal trial evaluating the Paradise ultrasound renal denervation (uRDN) system as a treatment for hypertension met its primary efficacy endpoint, demonstrating a statistically significant reduction in daytime ambulatory systolic blood pressure between treatment and a sham procedure measured at two months.
Also presenting data during the same EuroPCR session, David Kandzari (Piedmont Heart Institute, Atlanta, USA) offered three-year data from the SPYRAL HTN-ON MED trial, investigating Medtronic’s Symplicity Spyral renal denervation system, giving an overview of the impact of renal denervation on long-term time in target blood pressure range compared with sham control.
he RADIANCE II US FDA IDE pivotal trial is a randomised, sham-controlled clinical trial of the ReCor Paradise uRDN System for the treatment of patients with uncontrolled hypertension. Across more than 60 study centres in eight countries, 224 patients with mild-to-moderate uncontrolled hypertension, previously treated with up to two “Despitemedications.thetruly formidable challenges of conducting a complex clinical trial in the throes of the COVID-19 pandemic, we are thrilled to observe these positive results of RADIANCE II, especially in light of those we have previously reported from RADIANCE-HTN SOLO and TRIO,” said study principal investigators Ajay Kirtane (Columbia University, New York, USA) and Michel Azizi (Hôpital Européen Georges-Pompidou, Paris, France).
The results show that a 10% time in target range increase in the first 12 months reduces the odds of MACE events in the following 24 months and led to the conclusion that sustained blood pressure reduction after renal denervation predicts a meaningful reduction in clinical events. In this global registry, which involved 3,077 patients, those who underwent radiofrequency renal denervation spent a greater amount of time in target blood pressure range and had less cardiovascular events including cardiovascular death, myocardial infarction, and stroke.
Six-month functional patency and freedom from target lesion revascularisation (FFTLR) results with Flex Vessel Prep are as follows:
“Therethem.is obviously an unmet need, and renal denervation represents a device-based treatment option to tackle that problem,” he said.
Speaking in a press conference ahead of the presentation of the data, Felix Mahfoud (Saarland University Hospital, Hamburg, Germany) told attendees that renal denervation represents a device-based treatment option to tackle the problem of “Despitehypertension.alladvances in care we still have a significant proportion [of patients] that are either
Day one of the interventional cardiology meeting saw the release of data from clinical studies assessing the use of renal denervation as a treatment for hypertension, including the Global Symplicity Registry, SPYRAL HTN-ON MED and the aforementioned RADIANCE-HTN SOLO and TRIO.
Issue87 | September 2022 19Vascular Access
NEW DATA PRESENTED AT the 2022 Vascular Access for Hemodialysis Symposium (VASA; 9–11 June, Charleston, USA) have demonstrated favourable outcomes with the Flex Vessel Prep system as compared to historical data, and “really impressive” results in the cephalic arch and in arteriovenous grafts (AVGs), according to a VentureMed Group press release.Therelease also notes that this indicates a longer-lasting solution, as compared to standalone percutaneous transluminal angioplasty (PTA), in the treatment of arteriovenous fistulas (AVFs) and AVGs.
A patency of 69% for cephalic arch lesions—211 days FFTLR, versus historical data of 8–52%
RADIANCE II is the third and largest component of ReCor’s RADIANCE Global Program—randomised and sham-controlled studies evaluating the Paradise uRDN System in patients with hypertension. The first two studies in the series are the previously
patients across eight US centres—were delivered by primary investigator and Vascular Access Society of the Americas (VASA) president John Aruny (Dialysis Access Institute, Orangeburg, USA).“Arteriovenous access failure is a significant issue for patients that interrupts lifesaving haemodialysis treatments, so physicians are always searching for new options to extend time between interventions,” said Aruny. “The FLEX AV registry six-month outcomes demonstrate sustained patency across most patients and really impressive results in the cephalic arch and AVGs over treating with PTA alone.”
“We know from large meta-analyses and prospective randomised clinical trials that reducing blood pressure is impactful for patients,” he added. “The problem is that we have available drugs that work quite well but patients do not like them and patients do not take
Time in target therapeutic range has become an established and validated measure of control for chronic disease conditions, Kandzari said in his presentation, adding that specific to hypertension, time in target range is an independent measure of blood pressure control and is an independent predictor of cardiovascular events.
RADIANCE II
A patency of 47% for all AVG patients—174 days FFTLR, compared with historical data of The6–34%VentureMed release also details that the Flex Vessel Prep procedure demonstrated excellent safety in the AV registry, with no serious adverse eventsThisreported.AVregistry also set a new standard for patient diversity and inclusivity, the release continues, as more than 65% (75/114) of the patients
Late-breaking trial data presented at EuroPCR 2022 (17–20 May, Paris, France) underscore the potential of renal denervation as an adjunctive therapy to treat hypertension, complementing existing firstline treatments including lifestyle modifications and medication, attendees of the conference heard.
EuroPCR draws attention to renal denervation as solution for hypertensive patients
undiagnosed or not sufficiently controlled to target blood pressure, and that holds true for almost all regions [of] the world,” he told assembled press.
Mahfoud then previewed data, which were released later during a hot-line session at EuroPCR, the threeyear Global Symplicity Registry results, assessing blood pressure and major adverse cardiovascular events (MACE) after renal denervation using Medtronic’s Symplicity system.
John Aruny
Findings from the FLEX Vessel Prep AV registry—a single-arm, prospective study conducted with 114 real-world
Paclitaxel eluting PTA balloon dilatation catheter Nanotechnologythatmakesthedifference 1. U. Teichgräber. Presented at LINC 2021 2. K. Deloose. Presented at LINC 20213- 1. T. Tang et al. Physician initiated, prospective, non-randomized Multi-center trial, Investigating the safety and Efficacy of the TReatment with the Luminor Drug Coated Balloon and the Angiolite Drug Eluting Stent of IVascular in TASC C and D Tibial Occlusive disease iN patients with critical limb ischemia– 12-month results. International Angiology, May 2021. 90.1% fTLR 3.5-year1 89.4% fTLR 2-year in complex lesions.2 81.6% fTLR 1-year in BTK.3
Then probed about the dual capabilities of both drug delivery and imaging compatibility, Nguyen shared how the polymer she is researching is naturally fluorescent. This means, she expanded, that “we can use multiple imaging modalities,” of which ultrasound is one, to determine “the location and quantity of the particle delivered.” This speaks to the shortcomings of current drug delivery methods, which lie in the fact they cannot be as easily localised. With the drug “encapsulated” inside the very polymer that facilitates precise imaging, there is no need for a separate “toxic quantum dye” in addition to the drug, to highlight where in the body the drug has travelled. “We can chase this polymer [over time],” Nguyen summarised. For PAD specifically “we want to focus on the muscle and where [within it] the nanoparticle ends up.”
Next on the discussion agenda was the significance of the polymer’s biodegradability: “We want [it to be] biodegradable so it will leave the body and not accumulate,” Nguyen stated. It is crucial, she went on, to be able to readminister the drug “many times” when treating PAD, but drug carriers, some of which contain metals, can
This would amount to an improvement on existing treatments for PAD, as, like those for cancer, and cardiovascular and lung disease, drugs, as they are delivered
namedrop them anyway—Nick Woodward and Neil Davies at the Royal Free Hospital in London. I just had a fantastic experience—they let me scrub and explained exactly what IR was. Before, I had thought that it was just cardiologists who did stents, and this showed me a whole other world. Independently of that, I then did a placement in radiology towards the end of medical school and my supervisor happened to be an IR. I really got inspired by the concept of ‘minimally invasive procedures under image guidance’—there is no other specialty like it.
Q: You have carried out COVID-19-related projects through UNITE, among others—what has come from this research so far?
It was not in the PAD space that Nguyen initiated her research, however. She explained that “at first, we worked with cancer, and cardiovascular and lung disease.” The motivation for entering into this area of research stemmed from
A: Our first project was on the impact COVID-19 had on IR training and services. As a trainee-led research collaborative, it was important to start with this. We found that, while a lot of surgical services had to stop because of the anaesthetic risk during the pandemic, a lot of IR services carried on, which highlights the importance of IR in the patient pathway. The next project was a multicentre study on the outcomes of cholecystostomy and over 30 centres collaborated— that work was presented at the BSIR meeting in 2021. It was great proof that we could mobilise trainees across the country, which had been done in other specialties, but never until then in IR. The papers from this study have now been accepted for publication.
NGUYEN OPENED THE conversation by recounting the emergence of nanotechnology: “I began working at UTA in 2005,” she relayed, “and at this time, nanotechnology was still new. I was interested in whether I could apply [a] nanoparticle as a drug carrier and an imaging agent.”
the fact that drug delivery to treat these conditions often results in side-effects for patients, she outlined. “When you deliver a drug, it will go all over the body […] Many drugs are effective, but toxic to the body.” This is where nanoparticles come in, she proceeded to detail, as they can be more specifically targeted within the body. In turn, this has “the potential to reduce side-effects.”
A: In my opinion, the medical school curriculum is already very congested, and IR does not really fall among the priorities, which was fair enough a few decades ago. However, it has now become such a vital cog of healthcare. Even with some medical school teaching, it is hard to get a full grasp of what radiologists do, and this was partly the ‘why?’ for IR Juniors. It was also personal—before my IR elective I was searching for a basic website or book to help me prepare and I felt like there was a gap. We hope IR Juniors, as a solution to this, is accessible and not too advanced.
An Initiative for Junior IRs
A: Just one day of a vascular surgery placement I did as a medical student was in IR, and that day changed my life. The consultants there probably do not know that they inspired me this much, but I am going to
MandalIndrajeet
Education is important, but research is too—IR has been one of the most innovative specialities. There are not that many avenues in the UK to explore IR research, and while not everyone is going to be an investigator or
currently, cannot always be targeted with desirable accuracy.
become toxic to the body in the long term. Her nanoparticle, however, can be “cleared by the body,” while allowing the drug it contains to act where it is targeted.Nguyen ended by casting her mind forward to the next five years, and the milestones that await them in this project. As far as the here and now is concerned, research is at the in vitro study stage, Nguyen elucidated, underlining that “much more work” will be necessary before they can test on humans. “We are testing on mice […but] hopefully, if everything is successful, we will move on to larger animals.” Clinical trials are likely to be at least five years away, Nguyen advised.
a researcher, it is still key to show that a career in research in IR is possible.
Issue87 | September 2022 21
Interview: UK-based initiative promotes awareness of IR among studentsmedicalandtrainees
INDRAJEET MANDAL, A SECOND-YEAR radiology registrar at Oxford University Hospitals NHS Foundation Trust (Oxford, UK), speaks to Interventional News about the interventional radiology (IR) initiative that he co-founded in 2019— IR Juniors. Mandal along with Niall Burke (NHS Lothian, Edinburgh, UK), Sachin Modi (Royal Free London NHS Foundation Trust, London, UK) and Navin Nagesh (Oxford University Hospitals NHS Foundation Trust) under the guidance of Gregory Makris (Guy’s and St Thomas’ NHS Foundation Trust, London, UK) and further support by Jim Zhong (Leeds Teaching Hospitals NHS Trust, Leeds, UK), launched the website to further awareness of the specialty. IR Juniors is now partnered with the British Society of Interventional Radiology (BSIR). The group aims to educate those at the start of their medical career how they can pursue IR, become involved in the initiative’s affiliated research collaborative (UNITE) and embark on an elective in IR abroad—and much more besides.
A conversation at the cutting-edge of drugdelivery nanotechnology
The University of Texas at Arlington (UTA; Arlington, USA) announced in June 2022 that Kytai Nguyen, a UTA bioengineering professor, had received National Institutes of Health (NIH) funding to develop a dual-capability biodegradable nanoparticle for use in treating peripheral arterial disease (PAD). The US$2.1 million grant will allow Nguyen, in collaboration with Jian Yang, a Penn State University (University Park Pennsylvania, USA) bioengineering professor, and Ralph Mason, a professor of radiology at UT Southwestern (Dallas, USA), to investigate the potential applications of a drug-delivering, fluorescent polymer. Nguyen discussed her project with Interventional News, shedding light on key aspects of this research.
A: As a speciality, IR has always been collaborative—among different specialities but also countries—and we wanted to show that as an IR, you are part of a huge network around the world. There are two parts to the Global IR section, the first being highlighting opportunities for training in countries such as Canada and Australia. You can learn new techniques during these fellowships, while sharing how things are done in the UK too. Secondly, IRs can help set up training programmes and infrastructure in less developed countries. Road2IR is a great initiative as part of which trainees from the UK and USA go to Uganda to set up an IR training programme. This teaches participants that the specialty is not just about fancy, expensive equipment.
Q: How did you end up as a radiology trainee with a passion for IR?
Q: UNITE—National IR Trainee Research Collaborative—is IR Juniors’ affiliated research group, which you also set up. Why was encouraging research involvement among students and trainees a priority?
Many drugs are effective, but toxic to the body.”
Q: Why do you think that there tends not to be much awareness of IR among medical students? What specifically led you to set IR Juniors up?
Kytai Nguyen
Q: The Global IR section of IR Juniors shows your commitment to widening access to all that IR has to offer, for clinicians and patients alike—what does this look like in practice?
The day that my oldest daughter came to the world, I received a call from my chief nurse whose daughterin-law had just given birth to twins in a small clinic in a Parisian suburb. She had had a very severe form of postpartum haemorrhage, and she also had a coagulation disorder. The obstetrician had already left for the weekend and the ambulance could not transport her to the hospital because she was so haemodynamically unstable. I ended up embolizing her successfully in a very basic radiology room without any angiographic facilities, in the small clinic she was in. This was probably the most emotionally intense day of my entire life— there was the extreme happiness I felt at the arrival of our newborn, and then the stress of this intervention. I have kept a ‘basic embolization kit’ in my car ever since…
22 September 2022 | Issue87
What are the most challenging aspects of using IR techniques to diagnose and treat liver cancers?
Developing a new therapeutic concept, and building the preclinical evidence, was extremely challenging. However, this was a lot of fun, even if finding money for experiments, going through the process of
I have kept a ‘basic embolization kit’ in my car ever since.”
IllustrationWatt/NBAndy
I am lucky to have had fantastic radiology mentors. Alain Roche in Paris and Michel Lafortune in Montreal have really impacted my work. Both are extremely patient-centred and are highly respected both in and outside of their specialty. Michel Lafortune has also shown me that academic medicine—coming up with ideas, and designing a study, and then publishing it— can bring me a lot of joy. I also love the interventional oncology (IO) family that I have met over the years: Bradford Wood, Riad Salem, Ricardo Lencioni, Patrick Chevallier, Thierry de Baere, Afshin Gangi, they are more than colleagues; we have had this shared adventure in the development of IR and IO. I have also welcomed fantastic fellows to Lausanne—the stars of today and tomorrow—including Rafael Duran and Boris Guiu, who are working together on CIRSE’s (Cardiovascular and Interventional Radiology Society of Europe) ‘Interventional Oncology for Immunooncology’ initiative.
You patented chemoembolization composition including anti-angiogenic agents, which was then licensed for use in the VEROnA study, now completed. What was the patent process like from your researcher’s standpoint?
Could you describe a particularly memorable case of yours?
This year’s ECIO featured the first IO foundation course––what is the significance of this for the future of IO and its practitioners?
patenting, and then trying to license the product, was as exciting as it was difficult. In the end, the product licensed to BTG was approved for use in a clinical trial, which yielded interesting results. I also learned a lot from my exchanges with the industrial partners. Unfortunately, the project was not considered enough of a priority to be continued.
You recently published, in the Journal of Hepatology, a report on your experience with portal vein recanalisation? What do you think your results brought to the medical community?
and clinical improvement in 70% of cases and improves the nutritional status of patients. On the other side of the Atlantic, Riad Salem developed another treatment for the same disease. Time will tell whose is better….
techniques have had to demonstrate their validity through strong medical evidence, too. Designing a trial, finding the money to run the trial and recruiting patients, all of these are tricky tasks.
In 2018, we acquired an angiosuite combined with a computed tomogrpahy (CT) scanner in the same room. This kind of interventional suite has been used in Japan for years under the leadership of Yasuaki Arai, but not much in Europe. This has been a gamechanger in our practice for all procedures that require both angiography and percutaneous intervention. Of
This is actually the first large single-centre study of portal vein recanalisation in symptomatic chronic portal obstruction. This study reflects 15 years of practice in this rare and often misdiagnosed disease and demonstrates that this technique can be offered even after decades of portal obstruction. It leads to symptom
Alban Denys is a French-Swiss interventional radiologist who was one of the founding members of the Society of Interventional Oncology (SIO). He has held the position of chairman of the European Conference on Interventional Oncology (ECIO) and developed and patented a chemoembolization method that includes anti-angiogenic agents. Passionate about mentorship and giving up-and-coming interventional radiologists quality fellowship opportunities, Denys is head of diagnostic and interventional radiology (IR) at the Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne, Switzerland. Interventional News spoke to him about his career highlights, research interests, and what is required to succeed as an interventional radiologist.
Alban Denys
What attracted you to a career in IR?
I actually discovered IR by chance during my residency. I was lucky enough to be working at the Gustave Roussy Institute (IGR) under the supervision of Alain Roche with a bunch of other young fellows. At the IGR, I discovered a brand new field of medicine where image guidance could facilitate effective, yet less minimally invasive treatment. I had also found myself a little frustrated by diagnostic radiology, where there is not much close patient contact. IR was a way to be more directly involved in patient care.
During your professorship at CHUV Lausanne, what would you say the biggest shift in IR practice has been, both in your hospital and more widely? How has this impacted interventional radiologists’ approaches to cases and the consequent patient outcomes?
The real challenge is to develop an oncologic approach; to work out when best to perform an IO treatment, you actually have to develop skills and knowledge in both surgery and oncology. Our
Who were, your mentors?
This brings me back to my previous comment. We have to have an open dialogue with the oncologists we work with. This means understanding how they work and seeing things from their perspective, to then offer our solutions for the patients, at the right point in their treatment. But we should also be able to challenge oncologists’ decisions sometimes. And you can only do this if you have an in-depth knowledge of oncology. The IO foundation course is intended to equip our younger colleagues with this knowledge.
PROFILE Interview
2009–present: Professor and head of Diagnostic and Interventional Radiology at the Centre Hospitalier Universitaire Vaudois (CHUV; Lausanne, Switzerland)
Interview
2002: Associate Professor, Department of Radiology and Radiology, University Hospital, Lausanne
23Issue87 | September 2022
You have spoken about the positive impact of the combined angiosuite on your practice—have there been any IR advancements during your career that you had hoped would also be game-changing, but which were actually disappointing?
2013–present: Fellow of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE)
Medical education
Past appointments
2010: Professor, Head of Digestive and Oncologic Imaging and Interventional Radiology, CHUV
SSR (Société Suisse de Radiologie) SFR (Société Française de Radiologie) ESR (European Society of Radiology) SIO, founding member (2017)
What are your hobbies and interests outside of medicine?
Interventional
1980–1987: Medical degree, Université Paris V 1988–1993: Residency in radiology
course, cone beam CT is also an option, but it has the disadvantage of being way more limited in term of imaging quality. We use our combined angiosuite and CT everyday and it has made us feel more secure and confident in our techniques, and probably also improved our clinical results.
1991: Master of Science—‘Magnetic resonance imaging of neuronal graft in animal model of Huntington disease’, Université Paris V 1993–1994: Research fellow, Hepatic imaging, doppler and interventional radiology, SaintLuc Hospital, University of Montreal, Canada
Mentorship was the subject of this year’s Charles T Dotter lecture at the Society of Interventional Radiology (SIR) Annual Meeting––why is this so important in IR and how can interventional radiologists seek to be better mentors?
Current Appointments
CIRSE
Mentorship in every interventional or surgical activity is crucial; it is so important to be at young colleagues’ sides in the angiosuite. The transmission of all the tips and tricks of IR can only be done this way. The development of phantom and robotic IR will certainly change this approach in the near future, just like it did for laparoscopic surgery.
I had the privilege of helping develop thermal ablation as an alternative treatment to ethanol injections. The technique and results are well established in the field of hepatocellular carcinoma (HCC) now, but not so much for liver metastases. However, this is changing––thermal ablation is gaining ground for metastatic lesions too. Radioembolization is also a fantastic treatment very well tolerated by patients and it has yielded great results in treating advanced HCC. Despite some disappointing trials, improving understanding of dosimetry’s role is benefiting the technique. We are now doing more and more of these patients every year.
One of my main hobbies is biking, either in the Swiss mountains or in my beloved Normandy where we have a beach house. I also try to listen to live jazz music whenever I get the chance and I love reading books (particularly modern American authors like Jim Harrison). I am lucky enough to have been married for 30 years now, to a painter, and we enjoy visiting the museums and galleries in the places we visit on our travels, often with our children too.
Society memberships
Moving on to discuss the results of his study— whether or not they were as expected—Ahmed conveyed how he had been surprised by how they were “very, very consistent with what we thought”. This was the case for “every metric [and even with] propensity matching.” Ultimately, rates of intra-abdominal and intracranial bleeding, as well as hospital readmissions were “all one to two times higher with systemic thrombolysis.” Ahmed acknowledged that it was an outcome that “almost felt too good to be true,” especially since the patients at higher risk of bleeding are often those who receive catheter-directed treatment. “If we were going to see no difference,” Ahmed admitted, he would have expected it to be as a consequence of the sickest patients receiving this less evidence-based treatment. Finally, conversation turned to next steps regarding the picture of PE treatment and research in the
A database study titled ‘Unplanned 30-day readmissions and in-hospital outcomes for the management of submassive and massive acute pulmonary embolism: Catheter directed versus systemic thrombolysis’ has produced results that could provide some of the evidence base for preference of catheter-directed over systemic thrombolysis in treating the more severe cases of pulmonary embolism (PE). Osman Ahmed, who is author of the study and associate professor of radiology at the University of Chicago (Chicago, USA), met with Interventional News at the Society of Interventional Radiology (SIR) 2022 Annual Meeting (11–16 June, Boston, USA) to discuss his research. The abstract was also presented by Waseem Wahood (Dr Kiran C Patel School of Allopathic Medicine, Fort Lauderdale, USA) during the meeting’s pulmonary embolism session.
Asked then why he choose to approach the study from the angle of side effects, Ahmed offered by way of explanation the “very high chance of recurrence” with PE. “If you survive [the rate can be between] 30 and 40%”. Furthermore, Ahmed underlined, the nature of the treatment means that “if you give too much of the [PE] medication, the risk of bleeding is high, but too little and you do not clear the BleedingPE.”was
One of the key advantages of the catheter-based approach is that it is minimally invasive, Ahmed
future. “Trials […] take a lot of time and cost a lot of money,” Ahmed emphasised, which, in turn, accentuates “the beauty” of his study, conducted with a 36,000-strong patient base. “We really need [more] trials,” Ahmed affirmed, expressing his hope that the promising results his research has yielded will “pave the way” for increased government funding assigned to future PE research.
higher frequency of intravenous catheter use.UEDVT is usually categorised as primary (effort thrombosis or PagetSchroetter disease) or secondary UEDVT, which is mainly caused by an intravenous catheter or cancer. The distinction between primary and secondary UEDVT is important to guide treatment strategies. Effort thrombosis or Paget-Schroetter syndrome usually
VENOUS THROMBOEMBOLISM (VTE) is a major public health issue and deep vein thrombosis (DVT) affects about one in 1,000 patients. Each year, VTE kills more patients in Western Europe than breast cancer, prostate cancer, AIDS and road traffic accidents combined. Upper extremity deep vein thrombosis (UEDVT) accounts for approximately 5–10% of all cases of DVT with incidence increasing owing to
Endovascular treatment of upper limb DVT
“a big problem” in the patients from the database who had received systemic over catheter-based treatment, which often resulted in rehospitalisation—problematic in that it depletes resources and beds for patients with other conditions, Ahmed highlighted.
The first question posed to Ahmed was regarding the existing PE treatment landscape and what determines whether a given patient will receive catheter-directed or systemic thrombolysis. Ahmed dubbed this “a great question” to which the answer lies in the fact that “PE in general is a heterogenous disease, with different levels of severity”—massive, submassive and low-risk. “Fortunately,” he continued, “most patients are low risk”. Expanding on this, Ahmed specified how it is the massive and submassive patients who “require hospitalisation and often follow-up intervention,” which is, “where IR comes into play.”
Treatment aims to prevent recurrent DVT, post-thrombotic syndrome (PTS) and pulmonary emboli. One of the main goals is maximum thrombus removal, since residual thrombus is associated with recurrent DVT and PTS. Again, certain aspects of UEDVT challenge the endovascular approach, more so than in iliofemoral DVT. For example, strong curvatures at the level of the innominate vein makes it difficult to physically reach and remove walladherent thrombus. Furthermore, the short length of the superior vena cava (SVC) makes stable filter placement virtually impossible. These aspects
Ahmed began by outlining his clinical background and what led him to pursue this research on PE treatment. Clinically, he explained, one of his main interests is venous thromboembolism, but being the co-chair of the SIR Comparative Effectiveness Research Committee— an arm of the society whose goal is to develop “evidence-based data to compare interventional radiology [IR] services and procedures with their medical and surgical alternatives”—he wanted also to incorporate this area of focus into a study.
DatabaseThrombectomy study could open up field for catheter-directed PE treatment research
September 2022 | Issue8724
modality to confirm a clinical suspicion of UEDVT. Antegrade angiography is only performed if endovascular treatment is considered. In these cases, intravascular ultrasound (IVUS) is always recommended. IVUS is extremely accurate in identifying underlying compressions, intraluminal webs or trabeculations and residual thrombosis. While most experience with endovascular thrombus removal has been gained in iliofemoral DVT, similar consideration are valid for UEDVT.
Comment & Analysis
Rick de Graaf
PE in general is a heterogenous disease, with different levels of severity.”
AhmedOsman
pointed out, however, “most society guidelines [for PE treatment] outside of IR […] do not recommend what we do.” Ahmed asserted his nonetheless widely shared belief that catheter-based thrombolysis is “safe.” Studies carried out before his, while smaller, showed “a similar rate of effectiveness” between catheter-based and systemic treatments, but the former saw “lower rates of bleeding.” Ahmed referred to this existing, promising evidence as motivation for doing his database study.
results from physical exercise in patients with an underlying thoracic outlet obstruction at the intersection of the clavicle and first rib. In contrast to the underlying cause of iliofemoral DVT (most notably May-Thurner compression), this anatomic anomaly should not be treated with stenting because of the high rate of fractures and reocclusions. Pharmacomechanical thrombectomy should always be followed by surgical decompression to increase long-term patency. Secondary UEDVT is more likely to be treated solely by catheter-directed strategies. Cross-sectional imaging may not be as valuable for identifying and categorising UEDVT as it is in iliofemoral DVT. Indwelling catheters or pacemaker leads, bony compression and mediastinal movement all pose challenges for accurate interpretation. Moreover, real-time imaging during abduction and adduction of the involved extremity maybe helpful to identify a position-dependent obstruction. Although hampered by suboptimal vein compression, Doppler ultrasonography is probably still the primary imaging
Yet, of note, is the fact that even without these prospective trials and the inclusion of catheter-directed thrombolysis in the majority of PE treatment guidelines, there has been, of late, a “tenfold increase” in the recourse to catheter-directed treatment. Ahmed ended on the following note—”We are hoping that [our study] helps provide the framework” to include catheterdirected thrombolysis in guidelines more widely.
Bale’s stereotaxy workflow, he detailed, begins with “precise planning of multiple overlapping ablation zones”, to determine isotherms and to cover the whole tumour plus a safety margin. The next step, Bale relayed, is to place needles/probes in accordance with the plan, using respiratory triggering.
Consequently, Bale concluded, SRFA is now regarded as the first-line treatment by the Innsbruck Tumour Board for most patients with primary and secondary liver tumours, encouraging clinicians first to ask themselves whether ablation could be an alternative to resection in HCC and colorectal liver metastasis patients. The advantages of the additional use of stereotaxy and image fusion are that it enables the interventional radiologist to treat more patients more consistently, with curative intent, minimally invasively, and while sparing tissue. Moreover “the beauty of the technique,” Bale emphasised, that “it is easy to teach” and that “training of three-dimensional needle trajectory planning can be done in your own lab on virtual patient datasets.”
Fig 1(D) ablationshowingenhancedcontrast-Finalctlargezone with sufficient margin (as confirmed by image fusion)
Rick de Graaf is Director of Radiology, Interventional Radiology and Nuclear Medicine at Klinikum Friedrichshafen, Friedrichshafen, Germany.
Reto Bale (Medizinische Universität Innsbruck, Innsbruck, Austria) gave a presentation titled ‘Stereotactic thermal ablation—can it break the current limits?’ at the 2022 European Conference of Interventional Oncology (ECIO; 24–27 April, Vienna, Austria). A key takeaway was that although the 3D planning and other elements of the stereotactic procedure may require more effort than conventional ultrasound (US)and computed tomography (CT)-guided ablation approaches, the results that it yields are “excellent.“
After successful thrombectomy, compression stockings are not routinely recommended.Asforiliofemoral DVT, the treatment of UEDVT nowadays is essentially endovascular with some cases requiring a hybrid approach. Dedicated imaging techniques and tailored endovascular management are essential to optimise long-term outcome after thrombectomy for UEDVT.
Ablation Planning
Fig 1(A) planning ct showing crlm in segment VIII with 3 cm diameter
Verification of precise coaxial needle placement by image fusion.
1c1a 1b 1d
Referencing histopathological evidence of the treatment’s success, Bale acknowledged the results of his study, which evaluated 188 hepatocellular carcinomas (HCCs) in 96 patients—the residual tumour rate was 2.7%. In lesions greater than 3cm, the residual tumour rate is still as low as 3.8%, Bale added.
Disclosures: The author declared the following relevant disclosures: speaking/ consulting fees from Bentley InnoMed; Philips; Inari Medical.
Fig 1. (A) UEDVT in a male patient with a swollen, painful left arm for seven days (first signs were three days before). (B) IVUS showing a subclavian and innominate vein subacute thrombosis with limited wall thickening. (C) Angiography after two passes with a wall-to-wall full-lumen mechanical thrombectomy system shows brisk flow through the recanalised segments. (D) IVUS shows complete thrombus removal. Note the vein wall thickening, not to be confused with residual thrombosis.
CA DB
Bale expanded on his previous explanation, conveying how a stereotactic approach is key when dealing with tumours greater than 3cm, as, larger than this, and ablation from a single-probe position may not be possible, hence the need for multiple needles, and the careful 3D planning that precedes their use.
Stereotaxy: ECIO hears advantages of ablation planning
percutaneous transluminal angioplasty (PTA) alone. However, as mentioned before, stenting should not be used at the costoclavicular joint.
BALE GAVE THE PRESENTATION AS PART of the ‘Imaging-guided local tumour treatment with curative intent—what lessons from radiation therapy can help us to optimise its planning?’ and the speaker covered an explanation of stereotactic thermal ablation, the logistical challenges of implementing it, and the outcomes it can achieve. Bale underlined to Interventional News that “interventional oncology must become reliable and reproducible,” and that this is what underpins the stereotactic approach.
may help to determine which strategy and which clot-busting device to use. In general, thrombolytics should not be considered anymore for primary treatment. These can be associated with extended treatment duration and increased bleeding risks. Modern (pharmaco-)mechanical devices use no or minimal thrombolytics which increases procedure safety.
Issue87 | September 2022 25
This intraoperative verification is an advantage that stereotaxy has over radiation therapy, which
was 0.5% mortality and 6% were major complications. Of particular note is that more than half of these major complications “could be treated in the same session by the interventional radiologist”. The same is true when treating multiple lesions—they can often be treated simultaneously, in a single session.
After interventional thrombectomy, patients are usually placed on anticoagulation with direct oral anticoagulants for six months.
disadvantage may be that old, more organised and wall-adherent clot is more difficult to remove by suction alone. In my experience, specifically with the aforementioned challenges of UEDVT in mind, a wall-to-wall full-lumen mechanical thrombectomy system is preferable. As shown in the figure below, successful thrombectomy of a 10-day-old UEDVT was achieved after two passes with this type of device through basilic vein access. IVUS demonstrated no residual thrombosis and no underlying stenosis, thus stenting could be avoided. In some special cases, short stents maybe used to overcome chronic lesions not responsive to
necessitates waiting until long-term follow-up imaging has been Speakingcompleted.totheoutcomes of treating his patients with stereotactic thermal ablation, Bale stated that they very obviously demonstrate how “the additional efforts” necessary in order to conduct 3D planning, stereotactic needle placement and image fusion “lead to excellent results”. He expanded upon this assertion, explaining that his team treated more than 3,500 tumours in this way between 2001 and 2020, in more than 1,100 patients, and that even patients with multiple lesions and lesions greater than 10cm respond well. The complication rate after 2011, Bale underlines,
Fig 1(B) Planning of 8 needle Figtrajectories1(C)
Since his very first stereotactic radiofrequency ablation (SRFA) in 2001 Bale uses the image fusion software of the stereotactic navigation system to superimpose the intraoperative contrast-enhanced control CT to the planning CT for verification of complete coverage of the tumour by the ablation zone. With regard to obtaining the results of the procedure, image fusion enables the interventional radiologist to see the results of stereotactic thermal ablation before the patient even wakes up.
Increasing procedure popularity and technical innovations have led to the introduction of multiple (pharmaco-) mechanical devices in the last decade. Many rely on an aspiration principle in which catheters up to 12Fr macerate and remove thrombus fragments. With increasing catheter size and aspiration power, these systems bear the risk of increasing blood loss. Another
“This is, as always, a focus upon the aorta as managed by cardiac aortic surgeons, open vascular surgeons and endovascular surgeons; from the aortic valve at one end, to the iliacs at the other end,” says Greenhalgh of the event’s 2022 edition. “CX Aortic Vienna, for those of you who have been to it before, is for all of those who manage the aorta,” he adds. “This is not just the surgeons, but the physicians—we have radiologists, imaging experts, vascular scientists and vascular nurses. All who manage aortic patients are welcome to come and join us for the digital edition on 24, 25 and 26 October this year.”
“CX Aortic Vienna is the unique chance to get together with cardiac surgeons and all kinds of vascular specialists that are treating the aorta,” says Zimmermann, discussing the importance of the multidisciplinary focus at the heart of CX Aortic Vienna. “The problem is that we have a transition zone in the arch and we—as vascular surgeons—
The format for the digital edition will follow the CX style of short talks, debates, and audience interaction, presented live via broadcast. The programme includes open and endovascular aortic techniques and technologies, including edited aortic cases.
“October is the time for aortic disease and to discuss newest trends, technologies and features in aortic therapy,” comments Kölbel. “We are focusing on both open and endovascular techniques and we are inviting the cardiovascular and vascular communities to come to CX Aortic Vienna, with a presence during the Dreiländertagung, and very much to the virtual event that happens a few days later.”
CardiacVienna and vascular surgeons collaborate at the vanguard of aortic care
Talking points
September 2022 | Issue8726 CX Aortic
The importance of multidisciplinary aortic approaches will be a key strand running through CX Aortic Vienna’s content and discussion, and the 2022 event will continue its mission to bring together specialists of all skills—be they cardiac, vascular or endovascular—to provide a comprehensive overview of cutting-edge aortic treatment.
move further and further into the ascending aorta with our endovascular techniques. This can only be done with the support of the cardiac surgeons, and this is the reason why we really look forward to CX Aortic Vienna because everyone comes together addressing this complex field.“
CX AORTIC VIENNA
For the first time, the meeting will also offer an in-person component from its home city, Vienna, Austria, where CX Aortic Vienna has been invited to provide two 90-minute primetime cutting-edge English-language sessions for attendees of the Dreiländertagung—the joint meeting of the Austrian Society of Vascular Surgery (ÖGG), the Swiss Society for Vascular Surgery (SGG) and the German Society of Vascular Surgery (DGG)—on Thursday, 20 October.
HAVING ATTRACTED A GLOBAL, ONLINE audience during its first two editions, CX Aortic Vienna will continue to reach out to the worldwide aortic surgery community. The 2022 edition features three days of high-quality digital programming, to be broadcast live from 24–26 October for the wider global audience, delivering a total of 15 hours of aortic education, which will also be available ondemand to registered attendees after the event.
Multidisciplinary approach
of technology and clinical information and sharing among experts. I would invite everyone to take the opportunity to learn a lot about vascular and aortic surgery at CX Aortic Vienna.”
World-leading faculty
The full programme has been curated by a Vascular, Endovascular and Cardiothoracic Executive board comprised of leaders in the field of aortic care including CX Aortic Vienna founding chair Roger Greenhalgh (London, UK), alongside Tilo Kölbel (Hamburg, Germany) who will moderate the inperson session at Dreiländertagung, Afshin Assadian (Vienna, Austria), Roberto Chiesa (Milan, Italy), Martin Grabenwöger (Vienna, Austria), Stéphan Haulon (Paris, France), Gustavo Oderich (Houston, USA), Markus Steinbauer (Regensburg, Germany) and Alexander Zimmermann (Zürich, Switzerland).
The programme encompasses discussion and debate spanning key talking points in the aortic space including aortic arch interventions, thoracic dissection, thoracic imaging, thoracoabdominal techniques, juxtarenal, abdominal aortic and iliac artery therapies.
Coselli adds: “The Charing Cross meetings are among the best with regard to the broad spectrum
CX Aortic Vienna is for all of those whothemanageaorta
JosephCoselli
We are focusing on both open andtechniquesendovascular KölbelTilo
From 2023 onwards, CX Aortic Vienna will be held annually in October as a hybrid meeting in-person in Vienna whilst simultaneously livestreaming globally.
The entire history of aortic surgery has been one of technical and clinical evolution
“I have had the honour and the privilege during my career to treat the aorta from the aortic valve all the way to the femoral arteries,” notes Joseph Coselli (Houston, USA), who has been among the expert speakers to have participated in previous editions of CX Aortic Vienna and is returning in 2022. “The entire history of aortic surgery, and vascular surgery to the same extent, has been one of technical and clinical evolution.”
GreenhalghRoger
CX Aortic Vienna returns in October for its third edition (24–26 October, Digital), bringing together world-leading specialists from the cardiac and vascular fields to discuss all facets of aortic care from selection to investigation, diagnosis, techniques and technologies. The meeting will showcase the latest approaches—open and endovascular—for the treatment of complex aortic problems spanning the aortic valve to the iliac arteries.
All the speakers were excellent. It was a perfect overview, and I was able to look back at the sessions on-demand
It was a great use of my time.learning!Intensive
AORTICVIENNA cxaortic.com CLASSICAL OPEN AND ENDOVASCULAR SOLUTIONS CARDIAC, VASCULAR AND ENDOVASCULAR AORTIC ADVANCES DIGITAL EDITION, LONDON 24–26 OCTOBER 2022 NOWREGISTER
CX Aortic Vienna was a revolution in aortic approaches and updated our knowledge in the speciality
Arthur began by noting that the study enrolled 150 patients with wide-neck cerebral aneurysms across 26 global sites, and its primary endpoints were originally assessed at one year, but researchers did “everything they could” to follow patients out to five years. He also said follow-up in a five-year study is “difficult”, adding that “COVID-19 has affected our practice and this study a fair amount”, and noting that the pandemic was responsible for some missing imaging data.
September 2022 | Issue8728 Interventional
COMPLETEocclusionrate 57.9% 58.1% AT ONE YEAR AT FIVE YEARS ADEQUATEocclusionrate 87.2%AT87.9%ONEYEAR AT FIVE YEARS ArthurAdam NEURO ROUND UP
Elsewhere at SNIS, a second study— presented by lead author Ali Alawieh (Emory School of Medicine, Atlanta, USA)—indicated another area that thrombectomy treatments could yet expand into: distal vessel occlusion (DVO) stroke. In this multicentre study, researchers analysed outcomes in nearly 7,500 patients undergoing thrombectomy for different types of strokes across 32 USTheycentres.found that, while this is another space in which thrombectomies are not typically deployed, post-thrombectomy clinical outcomes for DVOs were comparable to those seen in LVO stroke patients. “Thrombectomy has changed the way medical professionals care for patients with stroke,” said Alawieh. “If more stroke patients can experience this lifesaving treatment, we want to ensure that happens.”
Across nearly 4,000 patients, this analysis found that BAO stroke patients who underwent thrombectomy were younger, and were more likely to be female, as well as having a slightly higher NIHSS score and rate of atrial fibrillation, on average, than those who did not undergo thrombectomy.
Discussing safety findings, Arthur said: “It is really exciting to see that, in a trial of 150 patients, 148 of whom got the device, not one of the treated aneurysms has experienced a rupture—the ruptured aneurysms did not re-rupture and the unruptured aneurysms did not rupture.” Arthur also reported seven deaths and five subarachnoid haemorrhages, two of which were deemed to have been related to the device.
for BAO stroke
We feel that this is a real-world corroboration of the clinical findings demonstrated in both ATTENTION and BAOCHE.”
WEB flow diverter shown to be safe and effective in long-term cohort
Moving on to detail efficacy data, he stated: “In looking at occlusion status shifts, there are more patients with progressive occlusion than with worsening of occlusion status. And, using last observation carried forward methodology, we see a stable and high number of complete occlusions and adequate occlusions.”
Late-breakingNeurology data bolster supportingevidencethrombectomy
T
“We feel that this is a real-world
endovascular thrombectomy portends a mortality and disability benefit.”
involved conducting a retrospective analysis of the US National Inpatient Sample database and included non-elective admissions of BAO patients
with an NIHSS score >9 who received thrombectomy between 2015 and 2019. The study’s primary clinical endpoint was a favourable outcome, measured via ‘routine discharge’ of the patient to their home or acute rehabilitation, while safety endpoints included mortality and symptomatic intracranial haemorrhage.
Drawing comparisons between these recent findings and one-year WEB-IT data, Arthur reported an increased complete occlusion rate, from 57.9% at one year to 58.1% at five years, and a marginal decrease in terms of adequate occlusion rate, from 87.9% to 87.2%.
Arthur went on to add that, in WEB-IT’s US cohort, a retreatment rate of 15.5% (23 of 148 patients) was observed over the five years, and all retreatments were completed safely. He noted that “absolutely no aneurysm bleeds” occurred in the study, but said there were two significant, aneurysm-related adverse events following retreatment with a flow diverter—one of which involved a stroke, and one of which
The speaker further claimed that, while WEB-IT saw a retreatment rate of 15.5%, retreatments of WEB are “quite easy and quite safe”, although he followed this by noting there is a need to be “careful” when it comes to subsequent interventions after the first retreatment due to the dangers they pose.
THE SOCIETY OF NEUROINTERVENTIONAL Surgery’s (SNIS) 19th annual meeting (25–29 July 2022, Toronto, Canada) saw research involving the Woven EndoBridge (WEB; Microvention/ Terumo) device disclosed for the first time, with co-principal investigator Adam Arthur (University of Tennessee Health Sciences Center and SemmesMurphey Clinic, Memphis, USA) delivering a late-breaking presentation of five-year data from the WEB-IT trial.
“I think the WEB device has now been shown, in a long-term cohort—which is important—to be both safe and effective,” he added. “It is fantastic that none of these patients experienced the endpoint that we most wanted to avoid, which was haemorrhage of the aneurysm.”
Late-breaking research presented at the recent Society of NeuroInterventional Surgery’s (SNIS) 19th annual meeting (25–29 July, Toronto, Canada) has shown that thrombectomy procedures can achieve positive outcomes for patients experiencing strokes caused by a basilar artery occlusion (BAO)—despite typically being reserved for the treatment of large vessel occlusion (LVO) stroke.
Arthur concluded by noting that the intrasaccular segment presents a new strategy that he finds “extremely promising”.
corroboration of the clinical findings demonstrated in both ATTENTION and BAOCHE,” Al-Mufti said. “There are limitations to our study—we lack granularity, and we do not know about time from ‘last known normal’, but hopefully the overall size of the study will dilute the effects of these issues.”
Fawaz Al-Mufti
“Obviously, these are point estimates, and there is not enough statistical power to really say something meaningful, but I do find it intriguing that, at the MCA [middle cerebral artery] location, there is some suggestion of a higher retreatment risk. I think a larger cohort may tell us something interesting here.”
hese findings were delivered by lead author Fawaz Al-Mufti (Westchester Medical Center/ New York Medical College, New York, USA), who said: “Patients who receive thrombectomy increase their life expectancy by five years compared to patients who do not. For every 10 minutes saved in getting a thrombectomy, patients experience an additional month of life free from disability. Furthermore, BAO stroke is associated with 40% mortality and, of the survivors, 80% have severe deficits. This is especially true for BAO stroke patients with high NIHSS [National Institutes of Health Stroke Scale], where
resulted in patient death following an angioplasty.“Aneurysm location is interesting,” Arthur continued.
Al-Mufti detailed that this research, dubbed the BArONIS study, sought to build on recent breakthroughs achieved in the ATTENTION and BAOCHE studies in China, and assessed whether the positive outcomes seen in BAO stroke patients who underwent mechanical thrombectomy procedures in these randomised controlled trials are likely to translate to Western populations.BArONIS
At SNIS 2022, Al-Mufti also detailed that BAO patients treated via thrombectomy were more likely to experience a favourable outcome, and there was no difference in the rates of mortality or symptomatic intracranial haemorrhage between the two groups. In addition, a subgroup analysis revealed that BAO patients with an NIHSS score >20 experienced a statistically significant benefit in terms of mortality rates, as well as favourable outcome benefits, after undergoing thrombectomy.
only operate Monday to Friday, during office hours.
The Clotild smart guidewire system (Sensome), which uses artificial intelligence (AI) to provide real-time insights on clot composition, is showing early promise in the first-in-human CLOT OUT study, according to Hal Rice (Gold Coast University Hospital, Southport, Australia). Rice discussed this novel technology and the potential it offers in endovascular thrombectomy procedures using electrical impedance spectroscopy at LINNC Paris 2022 (30 May–1 June, Paris, France).
As per its recent report, the UK Stroke Association is calling for:
In light of this, the Stroke Association’s ‘Saving Brains’ report has called for a 24/7 thrombectomy service. While this service could cost up to £400 million, the charity claims that treating all suitable strokes with thrombectomy would save the NHS £73 million per year.
model capable of recognising different compositions, which is then able to predict composition in unknown clots, RiceHereported.alsoclaimed that this use of electrical impedance spectroscopy presents a novel means for characterising occlusions in stroke, with data having shown continued coherence through ex vivo, animal and early inhuman research thus far.
The UK Department of Health and Social Care (DHSC) to develop a sustainable workforce plan to fill the gaps in qualified staff
Innovation—such as artificial intelligence (AI) imaging software and video triage in ambulances—to be put into practice
AI-powered device delivers “amazing physiologic information” to guide thrombectomy treatments
providing real-time insight on what the clot looks like, and the length of the occlusion. This translates to the sensor delivering higher impedance measurements in red blood cellrich clots, and lower impedance measurements for fibrin-rich clots, he added, reporting a “really good differentiation” between the two.
Hal Rice
The single-arm, multicentre study began in late 2021, is taking place across Australia and Europe,
Moving on to discuss the Clotild technology, Rice noted its unique, microsensor, which is 2mm in size and performs impedance measurements that are transmitted to the Cloviz tablet device via a Bluetooth transmitter,
he presenter started by noting that the first-pass effect is “very important” in this space, increasing the likelihood of a thrombolysis in cerebral infarction (TICI) 3 score and a “great clinical outcome” for the patient.
Issue87 | September 2022 29Interventional Neurology
and intends to enrol roughly 100 patients with an M1 (middle cerebral artery segment)-origin acute ischaemic stroke in order to collect a total of 60 clots.
THIS YEAR, NHS ENGLAND MISSED ITS original target of making thrombectomy available to all patients for whom it could provide benefit, only delivering the procedure to 28% of all suitable patients by December 2021, as per a Stroke Association press release.
“It really is simple—thrombectomy saves brains, saves money and changes lives; now is the time for real action, so that nobody has to live with avoidable disability. There is an unacceptable postcode lottery of stroke treatment. Rates are rising gradually due to sustained efforts from national and local stroke teams, but progress is far slower than it needs to be.”
He then detailed that the Clotild device uses a database centred around clots with a known composition. This database has been used to train a machine-learning
NHS England to address challenges in transfer to and between hospitals in its upcoming Urgent and Emergency Care Plan
The UK Treasury to provide urgent funding for thrombectomy in the 2022 autumn budget, including infrastructure, equipment, workforce training and support, targeting both thrombectomy centres and referring stroke units
The Saving Brains report highlights staffing shortages and estimates that achieving a universal 24/7 service would require doubling the number of interventional neuroradiologists (INRs) in the workforce, as well as the fact there are only 106 professionals who can perform thrombectomy in England—roughly four per centre. The report indicates that low thrombectomy rates are caused by prolonged ambulance response times, lengthy handovers and delayed inter-hospital transfers.
Stroke Association calls for 24/7 thrombectomy service across the UK
Providing a status update on CLOT OUT, Rice said the trial has enrolled 11 patients to date, with no devicerelated complications being observed in these completed cases, and the first Data Safety Monitoring Board meeting recently recommended continuation of theConcludingstudy.
Local systems to act on their Thrombectomy Quality Reviews and solve pathway issues that are currently holding back thrombectomy rate improvements
Stroke professionals quoted in the report cite insufficient bi-plane suites, containing radiology equipment, as a barrier to a 24/7 service being established.Despitemechanical thrombectomy having been shown to reduce disability and length of hospital stay in suitable stroke patients, rates of these endovascular procedures vary across the UK. Almost 8% of stroke patients receive a thrombectomy in London, compared to 0–3% in other parts of the country, the release notes. And, despite the unpredictability of stroke occurrences and criticality of timely treatments, just 25% of thrombectomy-capable centres operate 24/7 services, and close to half (42%)
The next part of Rice’s presentation homed in on the CLOT OUT trial, which is the first in-human study evaluating the safety of the Clotild smart guidewire system. Training and validating the aforementioned prediction model via a database is also a key objective of CLOT OUT, he noted.
his talk, Rice said this “exciting” technology is akin to other stroke care innovations like robotics and administering thrombolytics postthrombectomy.“Aswellaswhat we see on an angiogram or feel in terms of resistance during a procedure, this wire means we are now getting amazing physiologic information too,” he continued. “It also integrates very well into our current mechanical thrombectomy workflows.” Here, he reported that deployment of the Clotild device adds fewer than five minutes to the overall thrombectomy workflow. Rice also alluded briefly to future applications beyond clot composition and length, such as in vessel wall analysis to elucidate other key occlusion characterises like smooth muscle content and cholesterol— possibly identifying clots that are actually intracranial atherosclerosis (ICAS) lesions, thromboembolicnotocclusions.
A new report released by the UK Stroke Association warns that, if mechanical thrombectomy rates remain at 2020/21 levels, a total of 47,112 stroke patients in England would miss out on this “game-changing” treatment over the length of the newly revised National Health Service (NHS) Long-Term Plan. As such, the charity has called on the UK government to prioritise a 24/7 thrombectomy service and improve nationwide access to this “miracle treatment” moving forward.
patients back from near-death and alleviates the worst effects of stroke,” said Stroke Association chief executive Juliet Bouverie. “It is shocking that so many patients are missing out and being saddled with unnecessary disability. Plus, the lack of understanding from government, the NHS and local health leaders about the brain-saving potential of thrombectomy is putting lives at risk. There are hard-working clinicians across the stroke pathway facing an uphill struggle to provide this treatment and it is time they got the support they need to make this happen.
“Thrombectomy really is a game-changing treatment, yet the number of people receiving [it] in the UK remains much lower than elsewhere in Europe,” said Martin James (Royal Devon and Exeter Hospital, Exeter, UK). “At this rate, it will not be available to all those who could benefit for many years to come. We need to ensure thrombectomy is available to people with stroke wherever and whenever they need it, and that will require a big investment in people and equipment for the NHS.”
T
Rice noted that recent studies have also confirmed that clot composition has a significant bearing on patient outcomes too. Red blood cell-rich thrombi, for example, are more susceptible to distal embolisation, while fibrin-rich and platelet-rich thrombi may be harder to remove but also have less chance of embolizing distally.
Rice stated that, owing to the nine sensors on the device, arranged into three rows, it is also capable of identifying clots that have a ‘mixed’ composition— which may have substantial amounts of red blood cells, fibrin and platelets in their makeup—with this being signified by different impedance readings between the different groups of sensors.
The public to sign an open letter calling on the UK government to act on the recommendations in its Saving Brains report and provide a 24/7 thrombectomy “Thrombectomyserviceisamiracle treatment that pulls
Figure 1. Preprocedural (A, B) and postprocedural (C, D) CT images of a 68-year-old patient with unresectable multinodular bilobar HCC treated successfully with DSM-TACE. The patient showed >6 hepatic lesions, the largest of which was 7cm (A and B). DSM-TACE procedures were performed with a selective lobar catheterisation and with a coaxial technique placing a 2.7Fr microcatheter in the right or left hepatic artery that was feeding the tumour lesions. A solution of 450mg in 7.5ml of EmboCept S mixed with 50mg of Doxorubicin and non-ionic contrast medium was slowly infused. The patient experienced no adverse events, with dismission after 24 hours, without any pain or periprocedural complications. Since the CT follow-up performed after three months showed an almost complete response with necrosis of almost all multinodular liver lesions (C, D), the patient received two more DSM-TACE sessions. (Case: R. Iezzi)
“An important pillar of tumour treatment”: Degradable starch microspheres accepted by European guidelines
Overall, however, it is Iezzi’s opinion that DSMTACE is not necessarily in competition with DEB or cTACE, but provides another treatment option that interventionalists can offer to their patients, thereby widening clinical indications and improving disease prognosis overall. Iezzi adds that DSM-TACE “could also be used as bridge to other locoregional or surgical options as it is effective and repeatable (so called bridging and downstaging) being able to maintain vesselCIRSE’spatency”.approval of DSM-TACE has solidified its place as “an important pillar of tumour treatment,” says Kuhl. In recent years, a number of papers have been published that highlight the role of DSMTACE in HCC, and all of these have contributed to the acceptance of DSM-TACE in the CIRSE guidelines. For example, Iezzi was part of a team that recently had published a multicentre European study confirming that DSM-TACE is well tolerated with
Speaking to Interventional News, Roberto Iezzi, associate professor of Radiology at the Catholic University of Rome (Rome, Italy) and Christiane Kuhl, head of the Department of Radiology at Aachen University (Aachen, Germany), share their clinical experiences with EmboCept® (PharmaCept®) and how the European guideline update solidifies its place in liver cancer treatment by TACE.
In the field of embolic agents, both interventionalists are in agreement that EmboCept holds its ground, providing a solid treatment option and in some cases offering advantages over alternatives. “I think the most obvious advantage
Christiane Kuhl
31AdvertorialIssue87 | September 2022 THIS ADVERTORIAL IS SPONSORED BY PHARMACEPT
EmboCept is also characterised by a cross-linked, partially hydrolysed starch matrix that allows the interventionalist to obtain a ready-to-use solution with different chemotherapeutic drugs being mixed with them. Iezzi recalls how this feature positively impacted his practice: “This option allowed us to open the door in the last few years for new indications, for liver metastases from lung, breast and gynaecological tumours, for example. You can now use EmboCept with any cytostatic that can be given intra-arterially, allowing [the interventionalist] to be much more flexible and broadening the range of indications.”
References
the chemotherapeutic or cytotoxic agent through the tumour, but ideally keep it inside the tumour. “This is what EmboCept achieves in a perfect way,” Kuhl remarks. According to Iezzi, DSM-TACE can offer benefit where other TACE options, namely drugeluting bead TACE (DEB-TACE) and conventional TACE (cTACE), are not indicated. “DSM-TACE is safe, without side effects or worsening of liver function. It is also safe in advanced HCC patients, with worst clinical conditions (Child-Pugh>B7), vascular invasion (portal vein thrombosis), high bilirubin level or ascites—patients in whom DEB or cTACE could be contraindicated,” he relays.
Kuhl notes that the current CIRSE recommendation reflects the current level of evidence, but is still conservative regarding the patient cohort included. She states: “Maintaining liver function is decisive for a patient’s treatment as well as survival. A patient needs a working liver, both to survive, but also because an adequate liver function is a prerequisite for most systemic treatment protocols.” In patients with metastatic solid tumours, metastatic overgrowth of the liver can thus become the driver of a patient’s prognosis. Kuhl highlights that interventionalists now have the tools to help the liver fight against this metastatic overgrowth in addition to systemic treatment. “With systemic treatment, often in the liver, the dose is simply not high enough to stop the cancer,” she says, stressing that in these patients, palliation of liver function through local treatment is key, and is the major goal of liver-directed treatment. “This is similar to the local treatment of e.g. osseous metastasis to a vertebral body, where the intention is to palliate the static function of the bone,” Kuhl adds. “Similarly, in patients with secondary liver cancer, the aim is to palliate the liver. We are able to do that with EmboCept-driven transarterial chemotherapy”.
3. Ludwig, JM, Iezzi R, Theysohn JM, et al. European multicenter study on degradable starch microsphere TACE. The digestible way to conquer HCC in patients with High tumor burden. Cancers. 2021; 13 (20).
of EmboCept compared with other embolic agents is the fact that it only causes a temporary occlusion, maintaining the route to the tumour,” Kuhl opines. She believes this is crucial in the treatment of liver cancer other than hepatocellular carcinoma (HCC), where the main method of action may not be devascularisation, but in bringing the chemotherapeutic agents into the tumour. Kuhl elaborates: “Everywhere we want to treat chemosensitive cancer in the liver, these agents must be applied not only once, but repetitively—just as is usual practice with their systemic use. In such patients, temporary occlusion of vessels by degradable starch microspheres allows one to keep the route to the tumour patent for several courses of transarterial chemotherapy.” Such TACE should only temporarily occlude the vessels to avoid passage of
The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) recently incorporated transarterial chemoembolization with degradable starch microspheres (DSM-TACE) into its guidelines for hepatic transarterial chemoembolization.1 In addition to society backing, experts are also in favour of this treatment modality, underlining its role as a game-changing addition to the liver cancer care paradigm.
no major clinical adverse events and only limited major laboratory events.3 He tells Interventional News that preserved liver function was observed after repetitive DSM-TACE treatments in this study. “Our results confirm that repetitive DSM-TACE is a safe, well-tolerated and effective treatment option for HCC patients with high tumour burden ineligible or failing other palliative therapies,” said Iezzi, relaying the key take-away message from the paper.
“EmboCept consists of a suspension of starch microspheres that are rapidly and completely degradable within 90–120 minutes2 (in vitro half life time 30–40 minutes) from the arterial infusion, allowing a temporary occlusion of the arterial microcirculation at the tumor level,” Iezzi explains, giving an overview of EmboCept’s mechanism of action. This, he says, improves the therapeutic effect by reducing the immediate wash-out of the cytostatic agent, and decreasing the risk of systemic toxicity and post-embolic syndrome.
I think the most obvious advantage of EmboCept compared with other embolic agents is the fact that it only causes a temporary occlusion, maintaining the route to the tumour.”
“Guidelines are what drive clinical patient care,” Kuhl states, underlining the significance of the CIRSE update. DSM-TACE is now an accredited treatment option and this, according to Iezzi, “widens indications for locoregional treatments and gives new opportunities to patients”. In addition, he believes that the guideline update might convince all interventional radiologists, hepatologists and oncologists who were doubtful of the important role of DSM-TACE in the treatment of liver cancer.
1. Lucatelli P, Burrel M, Guiu B, et al. CIRSE standards of practice on hepatic transarterial chemoembolisation. Cardiovasc Intervent Radiol. 2021; 44 (12): 1851–1867. DOI: 10.1007/s00270-021-02968-1.
Christiane Kuhl Roberto Iezzi
2. Wiggermann, P, Heibl M, Niessen C, et al. Degradable starch microspheres transarterial chemoembolisation (DSM-TACE) of HCC: dynamic contrast-enhanced ultrasonography (DCE-US) based evaluation of therapeutic efficacy using a novel perfusion software. Clin. Hemorheol. Microcirc. 2012; 52 (2–4): 123–129. DOI: 10.3233/CH-2012-1590.
Biotronik will offer the Pulsar-18 T3 in up to a 200mm stent length for treatment of long lesions, the company advises and details that the Pulsar-18 T3 stent system is indicated for use to improve luminal diameter in patients with symptomatic de novo, restenotic or occlusive lesions located in the superficial femoral or proximal popliteal arteries, with reference vessel diameters from 3–6mm and total lesion lengths up to 190mm.
Safer imaging technology for complex aortic repairs uses light instead of X-rays
NeuroVasc announces first patient treated in clinical trial retrievernovelevaluatingstent
4Fr
“We are very proud to be participating in such trials to further advance the treatment we can offer to our patients,” said Nima Amin Aghaebrahim (Baptist Stroke and Cerebrovascular Center, Jacksonville, USA), who performed the first procedure in the ENVI RCT. “We are glad to get started on another landmark study, helping to bring new technology to our region and country,” added Ricardo Hanel (Baptist Stroke and Cerebrovascular Center, Jacksonville, USA).The study will compare the nextgeneration Envi-SR stent retriever with the Solitaire (Medtronic) and Trevo (Stryker) product families. Its results will support an application to the FDA for clearance of the NeuroVasc EnviSR device in the USA.
Biotronik’s Pulsar-18 T3 peripheral self-expanding stent system receives FDA approval
Selution SLR, sirolimus-elutingMedAlliance’sballoon,has received conditional US Food and Drug Administration (FDA) investigational device exemption (IDE) approval to initiate its pivotal clinical trial for the treatment of occlusive disease of the superficial femoral artery (SFA).
Ricardo Hanel
By analysing how light reflects back along the fibres, a computer algorithm reconstructs and visualises the full shape of the device. The result is a realtime, three-dimensional view of the blood vessel that surgeons can overlay on computed tomography images taken before the procedure, providing a roadmap that surgeons can view in any angle to guide the surgery. Timaran said that far fewer X-rays are necessary when using FORS, significantly reducing patients’ and staff’s exposure.
Selution SLR was awarded CE mark approval for the treatment of PAD in February 2020 and for the treatment of coronary artery disease in May 2020. The US FDA has awarded Selution SLR with four breakthrough designations: for the treatment of atherosclerotic lesions in native coronary arteries; coronary in-stent restenosis; peripheral below-the-knee and arteriovenous-fistula indications.
AngioDynamics announces FDA clearance of expanded indications for Auryon atherectomy system
A new imaging device at University of Texas (UT) Southwestern (Dallas, USA) is making complex aortic repairs safer for patients and operating room staff by dramatically reducing their exposure to radiation. The device, known as Fiber Optic RealShape (FORS; Philips), uses light to visualise blood vessels, nearly eliminating the need for X-rays typically used during minimally invasive vascular procedures.UTSouthwestern was one of about a dozen medical centres in the USA and Europe chosen to participate in the early implementation of FORS.
NeuroVasc Technologies has announced that the first patient has been treated in its US investigational device exemption (IDE) clinical study, the ENVI randomised controlled trial (RCT). The ENVI RCT will evaluate the safety and efficacy of the company’s ENVI-SR stent retriever, which is intended for the treatment of acute ischaemic stroke to reduce disability by removing blood clots in patients with large vessel occlusion (LVO) stroke.
low-profile delivery system may decrease the risk of access site complications and reduce the need for closure devices when compared to 6Fr devices, the company claims. It adds that the triaxial system with braided shaft design facilitates stable and accurate implantation of the clinically proven Pulsar stent and, with its thin struts and low chronic outward force (COF), the Pulsar-18 stent contributes to a reduced mean area of restenosis.Theredesigned Pulsar-18 T3 stent system offers physicians an “intuitive and ergonomic” wheel-operated handle for one-handed stent release enhancing the ability to control deployment, according to Biotronik.
“I was immediately impressed by the new concept of the Pulsar-18 T3 system,” said Koen Deloose (AZ Sint Blasius Hospital, Dendermonde, Belgium). “The combination of having a very ergonomic handle combined with a triaxial system and also everything in a 4Fr concept was, for me, quite unique.”
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Credit: UT Southwestern Medical Center
Selution SLR receives second FDA IDE approval
“By enrolling the first patient in this trial, we are taking an important step toward building evidence to support the clinical use of this novel, next-generation stroke device,” said Vitor Pereira (St Michael’s Hospital, Toronto, Canada), who is a co-principal investigator along with Raul Nogueira (University of Pittsburgh, Pittsburgh, USA).The study is a prospective, multinational, randomised, parallel group-controlled, blinded, noninferiority trial designed to examine
confident that this study will enrol quickly,” Adams commented.
“Complex aortic repairs tend to be long operations that require frequent in-procedure imaging. Every time a surgeon presses on the X-ray pedal, the patient and staff including assistants, nurses, scrub techs, anaesthetists, and X-ray techs get a dose of radiation,” said Carlos Timaran, professor of surgery at UT Southwestern. “The safety of each of these individuals is paramount, so reducing radiation exposure during these procedures is an important goal.”
The Auryon laser can be used to treat all infrainguinal lesion types, including above-the-knee (ATK), below-the-knee (BTK), and ISR, and to date, has been used to treat more than 21,000 patients in the USA, a company press release reports.“Combining the 2mm and 2.35mm Auryon laser atherectomy with the aspiration capability has changed our practice. We now treat acute limb ischaemia in a single session where we remove the acute component as well as treat the underlying lesion. Patients are now discharged in less than 24 hours without the need for an ICU bed or overnight lysis,” said Carlos J Guevara (Washington University School of Medicine, St Louis, USA).
Biotronik recently announced that it has received US Food and Drug Administration (FDA) approval of its Pulsar-18 T3 peripheral selfexpanding stent system. Full US commercial launch of the device will begin in early August, according to the threeuniquelyT3thatBiotronikcompany.statesthePulsar-18stentsystemcombinestechnologies.A
and compare clinical outcomes of patients being treated for acute ischaemic stroke as measured by modified Rankin Scale (mRS) score at 90 days post-treatment, and related performance characteristics, of the NeuroVasc Envi-SR and concurrent parallel control devices currently cleared by the US Food and Drug Administration (FDA) for treatment of ischaemic stroke.
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As an alternative to conventional imaging, the FORS device uses light travelling through hair-thin optical fibres built in specially designed catheters and wires to display its position and shape inside the body. Once this device is placed within a blood vessel, the strain on the optical fibres changes the light’s pathway.
In August 2021, the first of over 3,000 patients was enrolled in a coronary randomised controlled study comparing Selution SLR with any limus drug-eluting stent [DES]. According to MedAlliance, this is the largest drug-eluting balloon (DEB) study ever MedAlliance’sinitiated.DEB technology involves MicroReservoirs made from biodegradable polymer intermixed with the anti-restenotic drug sirolimus. These MicroReservoirs provide controlled and sustained release of the drug for up to 90 days. Extended release of sirolimus from stents has been proven highly efficacious in both coronary and peripheral vasculatures. MedAlliance’s proprietary CAT (Cell Adherent Technology) enables the MicroReservoirs to be coated onto balloons and adhere to the vessel lumen when delivered via an angioplasty balloon.
AngioDynamics has reported that it has received US Food and Drug Administration (FDA) 510(k) clearance of an expanded indication for the Auryon atherectomy system to include arterial thrombectomy.
The FDA recently cleared the expanded indication for the Auryon system’s 2mm and 2.35mm catheters to include adjacent thrombus aspiration when treating stenoses in native and stented infrainguinal arteries. Both catheters have aspiration capabilities as atherectomy devices, including in-stent restenosis (ISR).
This comes only a few months after the company received IDE approval for Selution SLR in the treatment of below-the-knee (BTK) indications (May
Enrolment2022). will begin in the SELUTION SLR IDE SFA study later this year. It will be conducted at over 20 centres in the USA and an additional 20 centres around the world. This study will enrol 300 patients to demonstrate superiority over balloon angioplasty. The principal investigator of this study is George Adams, the director of cardiovascular and peripheral vascular research at Rex Hospital (Raleigh, USA).“We are very excited that US patients suffering from PAD [peripheral arterial disease] will have the opportunity to receive this novel sirolimus drugcoated balloon technology. This is yet another advancement in the field of treating vascular disease and we are
A Concept Medical press release elaborates that LIMES is a prospective, multicentre, randomised controlled trial (RCT) that is designed and aimed to evaluate the Magic Touch balloon 0.014” and 0.018” versus
The RCT will measure the efficacy of sirolimus-coated balloons in a complex setting (CLTI) of the PAD segment (located below the P3 segment of the popliteal artery to the tibiotalar joint) against the current standard of care. The study’s primary endpoints are the composite of limb salvage and primary patency through six months. The key secondary safety endpoint is the composite of major adverse limb events and perioperative death at 30 days. A blinded core lab will assess patency at six, 12 and 24 months by duplex ultrasound and quantitative vascular angiography in case of any target lesion revascularisation.
Initiated by the University Hospitals Jena and Leipzig in Germany and led by principal investigator (PI) Ulf Teichgräber (Jena University Hospital, Jena, Germany) alongside co-PI Thomas Zeller (University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany) and Dierk Scheinert (University Hospital Leipzig, Leipzig, Germany), the trial kicked off with the index patient enrolled on 31 March 2022 by Nassan Malyar at the University Hospital Münster in Münster, Germany.
Synchron has announced the first human brain-computer interface (BCI) implant in the USA. This procedure represents a significant technological milestone for scalable BCI devices and is the first to occur in the USA using an endovascular BCI approach, the company claims, which does not require invasive open-brain surgery.
Surgery’s (SNIS) 19th annual meeting (25–29 July, Toronto, Canada) that it has recently received US Food and Drug Administration (FDA) 510(k) clearance for its Tigertriever 13 device to treat large vessel occlusions (LVOs).
standard angioplasty in a head-to-head comparison (1:1).
Stentrode endovascular electrode array
Rapid Medical gains US FDA clearance for “smallest and only” adjustable thrombectomy device
Rapid Medical announced at the Society of NeuroInterventional
Northeast Scientific, a company that reprocesses single-use peripheral vascular catheters, announced recently in a press release that it has received US Food and Drug Administration (FDA) clearance for reprocessing the Philips Spectranetics 0.9mm over-thewire Turbo-Elite laser atherectomy catheter.
Richard Saxon (Tri-City Medical Center, Oceanside, USA) shared: “A patient presented with trifurcation disease and severe calcifications in the superficial femoral artery (SFA), popliteal, and the posterior tibial artery. The low profile and pushability of the XO Cross 14 enabled pedal retrograde access following failed crossing and wire from above. A second XO Cross 14 (135cm) was used from above to support a flossing technique and subsequent angioplasty treatment. The unique non-tapered design of the XO Cross lends itself well to challenging limb salvage procedures that often require multiple access sites and different approaches to achieve a good outcome.”TransitScientific’s XO Cross
Administration (FDA) to a company assessing a permanently implanted BCI. The USA-based trial is being conducted with support from the National Institutes of Health (NIH) Neural Interfaces Program.
First patients enrolled in LIMES randomised trial of Magic Touch sirolimuscoated balloon in BTK interventions Concept Medical has announced the initiation of the LIMES trial, which has enrolled 15 patients to evaluate the safety and efficacy of the company’s Magic Touch sirolimus-coated percutaneous transluminal angioplasty (PTA) balloon for the treatment of peripheral arterial disease (PAD).
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The procedure marks the first US patient implant in Synchron’s COMMAND trial, which is being conducted under the first investigational device exemption (IDE) awarded by the US Food and Drug
Tigertriever 13 is the smallest revascularisation device in the world to date, according to the company, and is designed to remove thrombus from delicate brain blood vessels during an ischaemic stroke.
Northeast Scientific receives 510(k) for TurboElite laser atherectomy catheter reprocessing
Synchron announces first human interfacebrain-computerimplantinthe USA
LIMES will solve the question if sirolimus balloon angioplasty has the potential to become the future standard of care in BTK interventions.”
“We are beyond excited to get to work with our patient, guiding them through the training process as they learn to use this device to live more independently and, most importantly, communicate with their family and friends,” said David Putrino (Mount Sinai Health System, New York, USA), principal investigator of the COMMAND study.
According to Transit Scientific, the XO Cross catheter platform introduces new levels of pushability, trackability, flexibility, and torque response to access challenging lesions and complex anatomy. XO Cross’s non-tapered, metal-alloy and polymer construction delivers high fatigue resistance against tough lesions found in late-stage peripheral arterial disease (PAD) and CLTI, the company claims.
Mount Sinai’s Department of Rehabilitation and Human Performance helped coordinate the procedure.
The procedure was performed at Mount Sinai West in New York, USA and led by clinical investigator Shahram Majidi (Icahn School of Medicine at Mount Sinai, New York, USA). It was carried out in the angiography suite with a minimally invasive, endovascular approach.
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“Existing stent retrievers lack any adjustability—they open passively and are pulled from the brain fully expanded,” the release details. The unique adjustability of the Tigertriever portfolio comes from complex three-dimensional braiding borrowed from recent advances in aerospace engineering, it continues.
Synchron will continue to advance enrolment in its COMMAND trial as the industry-first FDA-approved clinical trial for a permanently implanted BCI in the USA. Recently reported long-term safety results have demonstrated this technology to be safe in four patients out to 12 months in Synchron’s SWITCH trial in Australia, as presented at the American Academy of Neurology’s 74th annual meeting (AAN 2022; 2–7 April, Seattle, USA).
In the press release, Teichgräber commented on why the RCT is valuable in terms of DCB intervention in infrapopliteal occlusions: “BTK [below-the-knee] revascularisation deals with the most challenging vascular territory in very sick patients.
platform features 24 US Food and Drug Administration (FDA)-cleared devices including 2Fr XO Cross 14 microcaths, 2.6Fr XO Cross 18 microcaths, and the 3.8Fr XO Cross 35 support catheters for use with standard 0.014”, 0.018”, and 0.035” guidewires in 90cm, 135cm, 150cm, and 175cm lengths.
This is the first time the FDA has awarded a 510(k) clearance for reprocessing this type of atherectomy catheter, the company claims.
Tigertriever is precisely controlled to capture the thrombus and remove the tension from the vasculature before removal. Adjustability also gives Tigertriever 13 the lowest profile of any stent retriever—24% smaller than 3mm devices, providing easier navigation in challenging anatomies, the company claims. It also states that the ability to tailor each procedure can provide new safety levels for higher-risk thrombectomies.
“The neurovascular field has been waiting for a thrombectomy device dedicated to small vessels,” said David Fiorella (Stony Brook University Medical Center, New York, USA). “Medical therapy is currently suboptimal for these patients, so there can be a huge benefit for devices that emergently restore blood flow while minimising the potential for harm.”
The COMMAND study will assess the safety and efficacy of the company’s motor BCI technology platform, including the Stentrode, in patients with severe paralysis—with the goal of enabling the patient to control digital devices hands-free. Study outcomes include the use of brain data to control digital devices and achieve improvements in functional independence.“Thisisanincredibly exciting milestone for the field, because of its implications and huge potential,” said Majidi, who performed the procedure. “The implantation procedure went extremely well, and the patient was able to go home 48 hours after the surgery.”
Transit Scientific has reported multiple successful peripheral vascular procedures with the XO Cross catheter platform utilising pedal retrograde access.Thenon-tapered 2Fr XO Cross 14 microcatheter in 90cm, 135cm, and 175cm lengths is designed to facilitate guidewire support, guidewire exchange, and contrast media injection during complex peripheral vascular interventions.“2Fr014catheter-guidewire systems are an important tool for pedal and below-the-knee interventions,” said George Adams (UNC REX Healthcare, Raleigh, USA). “The XO Cross incorporates a non-tapered torquable shaft design which supports a smaller and less invasive access site from below. Tools like these can help broaden options for approaches and access techniques in CLTI [chronic limb-threatening ischaemia] patients.”
Transit Scientific announces XO Cross success in CLTI pedal artery access
The LIMES RCT is set to enrol 230 patients in 19 centres across Germany and Austria. The patient population will include patients presenting with documented chronic limb-threatening ischaemia (CLTI) in the target limb defined as Rutherford clinical category 4, 5 or 6 aged ≥18 years. The study evaluates patients with a reference vessel diameter (RVD) ≥2 and ≤4mm and total occlusions (100% stenosis) of the target lesion. There is no minimal lesion length required, no lesion length limitation and no limitation in number of used devices. Follow-up will be per in-house visits at 30 days, six, 12, 24 and 36 months.
Continuing in a similar vein, Noorani outlines where CAS-One IR holds potential economic value for healthcare providers. “Patients with deep-seated lesions would, in the past, have had a hepatectomy,”
Workflow can also be managed better in a hospital with the length of procedure time being shorter and less variable, as “more challenging lesions can be done in a timelier manner,” and the increased accuracy of ablation with CAS-One IR means that, in time, Noorani “[hopes] to see a reduction in patients having repeat ablations.” Moreover, “a larger cohort of patients can be treated with curative intent,” to the same end.
A summarising remark from Noorani is that CAS-One IR allows for targeting lesions “at angles not previously achievable,” and this advantage is supplemented those conferred by the fusion software capabilities. Hoffmann’s own parting message is that, where in the past, ablation may have been prized by its practitioners as an art form, what IRs want now is to have “reproducible and accurate results.” Backing up his assertion with anecdote, Hoffmann stated that he finds it “embarrassing to go to a multidisciplinary tumour board meeting and be presented with evidence that there is a new tumour growing at the back of the ablation scar.” CAS-One IR is a means to avoiding such unsavoury scenarios, he concludes.
Martin
Ablation is used to destroy or shrink tumors in the liver, lung, kidney, bone, and other organs. In recent decades, image-guided ablation has become integral to modern cancer therapy with curative or palliative intent. Although a promising treatment option, the main challenge is the accurate and safe positioning of the ablation probes to achieve complete tumor coverage, especially in difficult-to-access localizations. The CAS-One® IR system (CASCINATION AG) and its AblaSure® margin assessment software aim to improve the reproducibility, reliability and accuracy of ablation procedures for liver, lung, pancreas, kidney and bone. It enables more patients, and those whose cases are more challenging, to be treated, and to reduce rates of recurrence and procedural complications.
Quality Ablation: Treating challenging lesions with increased accuracy and speed using a planning, navigation, and margin confirmation system
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On the hot topic of attaining sufficient margin, Hoffmann emphasises that there is, indeed, “huge demand for safety margin verification and that can only be achieved with a navigation system, such as CAS-One IR.” Image overlay, which is the means of verifying margins without such a system, is flawed, Hoffmann continues: “it can torque the kidney and liver,” and only works where there are “very advanced algorithms” at play. Noorani concurs, adding that post-ablation assessment is also “becoming more and more important […] economically to reduce re-ablation rates.”
NooraniShaheen
AblationQuality with the CAS-One IR System
Martin Hoffmann
Hoffmannresults.begins by stipulating that he has around five years’ experience with CAS-One IR, which contrasts with Noorani’s more recent incorporation of it into her practice. Hoffmann recalls being asked, when he started in his current hospital, whether he could find some way of treating large kidney- and liver-dominant tumour masses? This stemmed from the fact that, as Hoffmann elaborates, “we would see patients [who could not be treated systemically] declined from our surgical services.” So, CAS-One IR provides a solution for treating these “more challenging lesions in challenging locations” as Noorani puts it, illustrating that the pair share motivations for using the technology. Both Hoffmann and Noorani spoke of the advantage of achieving standardised ablation that is consistent from one patient to the next, and also from one IR to the next.
allowing the use of “an un-bordered array of microwave antennae” that work in tandem “to cover a large tumour volume, [ablating] section by section” in many different positions during the same procedure. Similarly, Noorani points to the issue of having “[to eyeball] the targeted ablation zone and needle position” when carrying the procedure out manually, which means that the “technical ability” of the IR is a “huge factor” in dictating how successful the outcome is. Furthermore, IRs encounter the issue of not being able to see the “invisible lesions” on CT that do show up on magnetic resonance imaging (MRI) scans— ablation of those lesions freehand is, consequently, impossible. Yet, Noorani clarifies that CAS-One IR resolves this problem, “[fusing] the MRI scans to the CT images.”
While CAS-One IR is versatile and usable with all ablation modalities and suitable for liver, kidney, lung, bone and other organs, it is AblaSure that adds value for patients, Noorani then shared, as being able to do margin assessment alongside the ablation means “we can re-treat on the same day, rather than bringing the patient back.”
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she begins, but as there is now the option for ablation with CAS-One IR, “[there will be fewer large operations, which] will ultimately mean reduced length of stay, [less] need for intensive care beds, and reduced wait for open theatre procedures.”
Asked about the challenges involved in using conventional ultrasound or computed tomography (CT) freehand ablation, Hoffmann reframes his response from the outset: “it is not so much a limitation of CT or ultrasound,” but the ablation modalities. He then explains that “one of the prerequisites of [using NanoKnife electrodes] is that they must be arranged parallel around the tumour,” which is very challenging manually. The CASCINATION system also has the advantage of
A case from Noorani: Trajectory plan, needle verification, AblaSure confirmation
You can read more about Quality Ablation and CAS-One IR at www.cascination.com
Hoffmann (St Claraspital, Basel, Switzerland) and Shaheen Noorani (Hampshire Hospitals NHS Foundation Trust, Basingstoke, UK) have experience using CAS-One IR with AblaSure to ablate advanced tumours where single or multiple electrodes are required to treat the tumour adequately. They believe that lesions can be targeted more accurately using the navigation system compared to the traditional manual ablation. Hoffmann and Noorani spoke to Interventional News about their experiences using CAS-One IR with AblaSure and contextualise these in the broader landscape of ablation, as well as detailing how, and for which patients, the CASCINATION offering yields advantageous ablation
Vascular experts establish appropriate use of IVUS in peripheral interventions
The authors begin by noting that the treatment of small-calibre vessel lesions using flow diverters “remains challenging” because of the vasculature’s narrow luminal diameter and tortuosity—which, in turn, makes navigation and delivery of conventional devices with standard microcatheters more difficult.
for
The authors noted that minimally invasive approaches for peripheral vascular disease interventions are increasingly common, but traditional imaging techniques like angiography have limitations, including twodimensional projections of threedimensional vasculature, which can complicate diagnosis and intraprocedural optimisation.
included a total of 212 PHP procedures for the 101 patients included in the study. Of the 101 patients, 66 received PHP as first-line treatment and 33 had received prior therapy (status of two patients was unknown). After a median follow-up time of 15 months, a complete response (CR) was reported in five (5%) patients; partial response (PR) in 55 (54.5%), and stable disease (SD) in 30 (29.7%), resulting in an objective response rate (ORR) of 59.4% and a disease control rate (DCR) of The89.1%.median progression-free survival (PFS), liver progression-free survival (LPFS), and overall survival (OS) were 9 months (95% CI 7.7–10.3); 11 months (95% CI 9–13); and 20 months (95% CI 13.7–26.3), respectively.
safe and effective use of the Silk Vista Baby (Balt) flow diversion device in the treatment of complex posterior inferior cerebellar artery (PICA) aneurysms.Writingin the journal Neurosurgery, Ricardo Hanel (Baptist Neurological Institute, Jacksonville, USA) and colleagues also state that, based on their findings, “the smaller delivery system profile reduces the risk of procedure complications and creates new treatment options for distal lesions”.
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“The voting panellists considered a variety of clinical scenarios and based on their extensive experience, arrived at a strong consensus,” said lead author Eric A Secemsky (Beth Israel Deaconess Medical Center, Boston USA). “They recommend routine use of IVUS as a preferred imaging modality in all phases for many peripheral interventions, both diagnostic and therapeutic, as it enables such exquisite visualisation of the target vessel and lesion. Their recommendations, which withstood the rigour of peer review, can now
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be considered in the formulation of clinical guidelines for the diagnosis and treatment of peripheral vascular disease.”
Clinical
News
Silk Vista Baby demonstrates safety and effectiveness in PICA aneurysm treatment
Results of a multicentre study of Chemosat hepatic delivery system published in CVIR Delcath Systems has announced the publication of a retrospective analysis of patients who underwent a percutaneous hepatic perfusion procedure (PHP) with Chemosat at three European centres, one in The Netherlands and two in Germany, between February 2014 and December 2019. The study involved 101 patients who completed a minimum of one PHP procedure for the treatment of unresectable uveal melanoma (UM) liverThemetastases.studybyTML Tong, et al,
Hanel and colleagues detail that databases from different centres were retrospectively reviewed for PICA aneurysms treated with the device, with demographic information, clinical presentation, radiographic characteristics, procedural complications, and immediate postprocedural outcomes, all being obtained.Theyreport that complete occlusion, measured as Raymond-Roy class I, was achieved in all cases, leading Hanel and colleagues to conclude that the device was safely and effectively used in the treatment of PICA aneurysms overall.
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Royal Philips has reported the establishment of the first-ever global consensus for the appropriate use of intravascular ultrasound (IVUS) in lower extremity arterial and venous interventions.Publishedin the August 2022 issue of the Journal of the American College of Cardiology: Cardiovascular Interventions, the new consensus document from 30 global vascular experts recommends routine use of IVUS as a preferred imaging modality in all phases in many peripheral vascular disease procedures.
Although the study did not find a statistically significant difference in either median PFS and LPFS for patients treated with two or more PHP procedures compared to patients treated with one PHP procedure, the study did find a statistically significant difference in OS (20 months vs. 8 months) for patients who had two or more PHP procedures compared to patients who were treated with one PHP procedure.
Following a retrospective review of databases from multiple different centres, researchers have reported the
The subscription model will be available to Interventional Systems’ customers in the USA and Europe from Autumn 2022.
Subscription model offers a flexible option to deploy robotics in the IR suite
As a result of this, hospitals may be missing out on the opportunity to access new technologies that will smooth workflows and improve outcomes for patients through high-quality care. To address this, Interventional Systems has sought to deliver a service that will allow hospitals to still have the opportunity to offer the innovative Micromate robotic system to their patients, albeit without the initial capital outlay that is usually involved in this kind of procurement.
One of the potential advantages of this model is, according to Peairs, the fact that healthcare providers will have the flexibility to incorporate an emerging technology into their practice, without the long-term outlay that comes with a commitment to capital expenditure on new equipment. And, with a subscription-based service, getting hold of a robotic system may be a more streamlined process, Peairs says, as the subscription may not fall into the capital expenditure category, meaning that the physician can incorporate the cost into the budget that they already control.
“The idea is that we want to give them access to it,” Peairs tells Interventional News “They can have a system and they are not obligated for the long term, that gives the physician access to it. From there, they can explore internally if it adds value to the procedures within their facility.” Additionally, without the initial outlay of the capital cost of the system, hospitals can potentially reap the efficiency gains that can be achieved by deploying the Micromate system, quicker.
“Only equipment that was broken or was desperately needed was being purchased under the capital price,” comments Peairs, adding that since the start of the pandemic, many providers have become wary of making capital investments, seeking more flexible solutions instead. “We are starting to come out of that cycle now and hospitals are starting to get back on more of a standard capital cycle, but we are probably another year away from normal.”
At the onset of the COVID-19 pandemic in early 2020, healthcare systems across the globe were forced, almost overnight, to adapt to a new reality. No corner of the healthcare landscape has been left untouched, and the ripple effects of the pandemic have changed the financial reality for care providers everywhere.
“We wanted to offer a way that, if the hospital does not have the budget but wants to use a robotic system, we can offer them a subscription model,” Peairs explains. The subscription model—which Peairs says is relatively unique to the healthcare technology setting—works in a similar way to how users purchase software packages.
“C
“Microsoft or Adobe are the best examples,” he explains. “You used to have to go and buy the software, it was loaded to a hard drive on a computer, and then you would have to go and buy an upgrade for it. The software companies have completely moved to the subscription model, where it is virtual. You get the free upgrades, it is accessible, and you can turn it on and off when you want to.”
As Micromate is a system that can be used in a number of different procedures on different organs, Interventional Systems says that there are several factors that will affect how long it may take to master the system. “A lot of it depends upon the type of procedure that they are doing,” says Peairs, adding that learning to use the platform in lung, kidney or liver tissues—the primary IR target areas—may have different requirements. From experience, and though it changes from physician to physician and centre to centre, five procedures is generally a good rule of thumb for getting to grips with the system, that he describes as a “third arm” for the operator.
“They want to use it on easy cases so the staff know the workflows and the setup using the robot, so that once they get to the hard cases that is not a stressor. I really see that is where a subscription model is going to help, because it is going to allow them to use it on all cases,” he says.
Scott Peairs
apital equipment sales are always a long-term process, with budgeting and approval processes,” Scott Peairs, VP of Global Sales at Interventional Systems, tells Interventional News. “The pandemic made that worse with a diversion of capital assets towards the treatment of COVID-19 patients.”
As these core services are essential, they are covered within each of the three packages on offer,
“Some of the IRs have told us that they would use it on the hard cases because that is where they would think they would have the need,” Peairs adds, commenting on the learning curve involved in mastering the robot. “Now the mindset has shifted and several of them have told us that they are going to use it on every case, even the simplest of biopsies, because of its fast setup.
Learning curve
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SuiteTableSetupMicromate
37AdvertorialIssue87 | September 2022
A flexible option
This has prompted a realignment in the way that hospitals and healthcare facilities approach the procurement of new technologies and devices, and creates a potential hurdle to investment in cuttingedge treatment solutions. For Interventional Systems, the developer of Micromate—a table-mounted medical robot for interventional procedures—this represents a particular challenge as hospitals refocus their spending priorities, and capital expenditure on new technologies becomes more difficult.
however, customers can opt to get access to more whenever needed, and have the option to upgrade or downgrade their subscription at any time. Furthermore, the system requires no preventive maintenance and the customer pays for service only outside warranty, and when needed. “To go back to the Microsoft analogy—it updates itself, you do not have to do service, you do not have to do training—it is all included in that subscription,” says Peairs. Setup and training are also important aspects of the provision which are delivered to clients at the outset of the subscription. Interventional Systems offers service support to troubleshoot any issues that may arise, and can centrally access the system via a remote interface. If hardware repairs are needed, Interventional Systems offers a “swap out” facility whereby faulty components are replaced to reduce downtime.
Interventional Systems offers three different subscription models that are structured depending on the volume of procedures to be performed using the robotic platform and the duration that the healthcare provider wishes to sign up to. The centre pays a fixed amount per month which covers the disposable components that are needed for each procedure, as well as software updates that may occur during the subscription time and technical assistance during the first cases.
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39AdvertorialIssue87 | September 2022 THIS ADVERTORIAL IS SPONSORED BY BD
Homing in on treatment options, the first breakout
In a subsequent breakout session dedicated to restoring dialysis access, cardiologist and interventional angiologist Samuel Heller (Charles University, Prague, and Angiocentrum, Příbram, Czech Republic) delivered one of the talks, speaking on the role of Aspirex™S (BD) mechanical thrombectomy in this field. “Percutaneous mechanical thrombectomy debulks thrombus load, leading to rapid revascularisation for an occluded dialysis AVG on an ambulatory basis,” Heller told Interventional News
Steinke shared an update of the AVeVA clinical study and the prospective, multicentre, concurrently controlled randomised AVeNew trial for outflow stenosis in AVF circuits. This study aimed to compare outcomes using the Covera Vascular Covered Stent to percutaneous transluminal angioplasty (PTA) alone for the treatment of stenotic lesions in the venous outflow of upper extremity AVFs.
Disclaimer: Please consult Becton, Dickinson and Company product labels and inserts for any indications, contraindications, hazards, warnings, cautions and instructions for use. The opinions and clinical experiences presented herein are for informational purposes only. The results from this case report may not be predictive for all patients. Individual results may vary depending on a variety of patient specific attributes. The clinicians have been compensated by Becton, Dickinson and Company to participate in this advertorial.
Interventional radiologist Ounali Jaffer (Barts Health NHS Trust, London, UK) advocates for the centrality of cross-specialty collaboration in order to deliver the
Also in this breakout session, vascular surgeon Robert Shahverdyan (Asklepios Clinic Barmbek, Hamburg, Germany) outlined a left-sided ulnar-ulnar WavelinQ EndoAVF case—one he said underlined his belief that the most important factor in a successful endoAVF programme is the planning.
of Insubria, Varese, Italy) reported the outcomes of cost-effectiveness and budget impact analyses he conducted with researchers from Bocconi University (Milan, Italy) comparing endoAVF creation to surgical AVF creation in haemodialysis patients from the National Health Service (NHS) perspective in Italy.
“YOU HAVE THE OPPORTUNITY TO engage with a tremendous group of experts and panelists,” one of the two chairmen, interventional radiologist Fabrizio Fanelli (Careggi University Hospital, Florence, Italy) informed delegates in his introduction to the meeting. Indeed, 14 world-class group faculty members and approximately 200 multispecialty experts—including nephrologists, vascular surgeons and interventional radiologists—led 200 attendees from 34 countries through the entire ESKD patient journey. They focused on a deep dive into the endovascular treatment options available to create, restore and maintain arteriovenous fistulas (AVFs) in dialysis patients, sharing their clinical experiences and technical skills via 30 educational sessions and 10 hands-on workshops.
Multidisciplinary community unites at inaugural patientfocused ESKD Summit
Addressing the economics of the WavelinQ procedure, vascular surgeon Matteo Tozzi (University
session at the meeting highlighted AVF creation using the WavelinQ™ (BD) EndoAVF System approach. Experts underscored how this approach provides a non-surgical fistula creation option in the patient life plan and future fistula management.
Tobias Steinke (Schön Klinik Düsseldorf, Düsseldorf, Germany) presented to the ESKD Summit attendees published studies evaluating long-term outcomes in AVFs requiring interventions to promote maturation, reporting primary patency rates and secondary patency rates.
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The roles and accountabilities of the different stakeholders in ESKD management formed a central part of the meeting. President of the European Kidney Patient Federation (EKPF) Daniel Gallego put forward the patient voice, telling delegates “the key to empowering people is education, not only information”. He outlined the need for an ongoing educational process, incorporating tools and support. Gallego noted that the fistula he had 27 years ago is still working. “This is because I have been involved in the care of the fistula,” he told delegates.
best patient-focused care. “I think the multidisciplinary team approach in this particular area is essential, not only in planning but also in maintaining these lifelines for these patients,” said Jaffer, who stressed this is only possible if stakeholders work “in a collaborative and open manner.”
“The Changing Face of a Dialysis Patient” was the central theme at BD’s EMEA ESKD Summit (17–18 May 2022, Madrid, Spain)—a meeting that championed patient-centric, multidisciplinary end-stage kidney disease (ESKD) management.
Create, restore and maintain: AVF treatment options
Nephrologist Jose Ibeas (Parc Taulí University Hospital, Barcelona, Spain) reiterated the importance of a patient focus in ESKD management, while also underscoring the significance of cross-specialty collaboration. “Vascular access is simple to understand but difficult to manage due to the complexity of the social environment, the characteristics of the patient and the heterogeneity of the health systems,” he communicated. According to Ibeas, it is necessary to understand fully the reality of the problem, and hence the reason for the need for vascular access registries, to manage knowledge in a uniform way, via guideline collaboration, and provide the best patient care thanks to up-to-date research, in order to offer the best possible treatment. “But none of the above can be achieved without adequate multidisciplinary training,” the presenter stressed.
The 14 faculty members are Fabrizio Fanelli, Nicholas Inston, Daniel Gallego, Ounali Jaffer, Jose
Ibeas, Tobias Steinke, Robert Shahverdyan, Matteo Tozzi, Samuel Heller, Fien Gryffroy (Imelda Hospital, Bonheim, Germany), Jose Maria Abadal (Hospital Universitario Severo Ochoa, Madrid, Spain), Shagran Binkhamis (King Faisal Specialist Hospital and Research Center, Riyadh, Saudia Arabia), Richard Kellersmann (University Hospital Würzburg, Würzburg, Germany) and Luigi Novelli (Hôpital Paris Saint-Joseph, Paris, France).
“If they have certain life priorities, even if it impacts on their overall outcome, we should respect that, rather than push them in a direction just because it offers a theoretical survival benefit. We should be looking at QoL benefits as equally important.”
The final session of the meeting addressed access maintenance, with Tobias Steinke speaking on how to treat challenging AVF lesions in the cephalic arch. He shared details of his experience using the Covera™ Vascular Covered Stent (BD).
The EMEA ESKD Summit put into sharp focus the need to place the quality of patients’ lives at the centre of a multidisciplinary ESKD management strategy. The results of a questionnaire sent to attendees following the Summit point to the importance of this collaborative effort, with 95% saying that the meeting “added value to their daily practice”. BD is looking forward to welcoming the ESKD community to the next edition of the EMEA ESKD Summit in 2023.
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Transplant and vascular access surgeon Nicholas Inston (University Hospitals Birmingham NHS Foundational Trust, Birmingham, UK), who was chairman of the second day of the meeting, spoke on the current ESKD landscape, stressing the importance of focusing on patients and their individual needs. Inston’s key message was that “patients are individuals,” with the only common thread between them being renal replacement. He stressed that, as clinicians, it is imperative not to assume what contributes to quality of life (QoL) for an individual.
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treating the patients, but the patients get referred to us by general physicians who do not know that we can treat these patients well”. He stressed that this is a problem across Europe, citing in particular his experience with this lack of awareness in Germany and in The Netherlands. Wigham confirmed this is also a “huge issue” in the UK.
think that ClotTriever is only possible to use inside that window of two weeks?” De Graaf asked Wigham. He responded that it is one of the “principal advantages” of the device that it is effective beyond two weeks. In fact, he noted that he has witnessed its effectiveness out to six weeks. “I would even say it is possibly more effective in that subacute phase, because you get such good luminal clearance,” he“Iremarked.thinkthat is the real game-changer […] that we have that range of treatment time available to us now,” Wigham summarised, homing in on the significance of this key benefit of the ClotTriever device, in addition to its ability to remove all residual thrombus. De Graaf agreed this is a huge benefit: “Sometimes, you just get referrals too late. This is a game-changer.”
MEDICALCIRSE
Indications for use: The ClotTriever thrombectomy system is indicated for (1) the non-surgical removal of thrombi and emboli from blood vessels, and (2) injection, infusion and/or aspiration of contrast media and other fluids into or from a blood vessel. The ClotTriever thrombectomy system is intended for use in the peripheral vasculature including deep vein thrombosis (DVT). See Instructions For Use for complete Indications For Use, contraindications, warnings and precautions. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
Join Inari Medical at the upcoming Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual meeting (10–14 September, Barcelona, Spain) for a symposium on ‘Advancing the treatment of VTE with lyticfree mechanical thrombectomy system’.
WighamAndrew
Rick Graafde
Wigham also referenced an issue that came to the fore in the UK during the COVID-19 pandemic— the costs of delayed treatment to both patients and hospital systems. “We had limited operating time, we had limited bed availability,” he recalled, “and one of the traditional treatments for acute DVT has always been thrombolysis, which comes with significant bleeding risk to the patient and has a significant impact on the health economics of a hospital in that it requires an ITU [intensive therapy unit] stay and oneto-one nursing.” This, Wigham noted, underscored the need for solutions to address the issues associated
According to Wigham, a lack of awareness ultimately affects DVT treatment. He explained: “One of the major problems we see relates back to the awareness issue. We know the traditional devices enable us to have only a limited window for effective treatment of acute DVT. Beyond two to three weeks, the clot becomes too organised and some of our currently available treatments are ineffective.” The problem, Wigham highlighted, is twofold: patients are often referred too late and many treatments do not work beyond a very limited time window.
symposium
“I am finally very confident I have a device that takes out all the thrombus,” stated Rick de Graaf (Clinical Centre of Friedrichshafen, Friedrichshafen, Germany) in a discussion on the current state of deep vein thrombosis (DVT) at the Leipzig Interventional Course (LINC) 2022 (6–9 June, Leipzig, Germany). De Graaf was here referring to the ClotTriever (Inari Medical) device, which he believes addresses the “major problem” of residual thrombus and offers the “game-changing” solution that is extending the treatment window.
ClotTriever® device
41AdvertorialIssue87 | September 2022
ClotTriever deemed a “game-changer” in deep vein thrombosis treatment
Wigham also uses ClotTriever in his practice, and describes the device as “very effective” in enabling interventionalists to clear thrombus and potentially limit the amount of stenting performed in what is typically a young patient population. This, according to De Graaf, is something those in the venous community have been talking about for “years”. In chronic cases, he explained, stenting might be
DVT patients. “In 2009, we started with thrombolysis, and that is something that you definitely do not want to do to young patients,” he relayed. “We went through all of the devices out there, and my major problem was always that I could not get the thrombus out.” The issue here, he explained, is that residual thrombus incurs a new thrombosis. “Thankfully, now, I am finally very confident that I have a device that takes out all the thrombus,” he reported, referencing the ClotTriever device. “That is the key thing— removing all the thrombus—and we now have that.”
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The investigational InnAVasc device is designed to protect the graft from backwall punctures and reduce the damage associated with frequent needle sticks which occur over the lifespan of a dialysis graft. This can lead to circuit failure and shortened circuit life. “To
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23–25 November 2022
GEST MSK Hot Topic Meeting 2023 Paris, France www.eventcreate.com/e/gestmsk2023
“Backwall punctures and damage due to excessive needling are painful and can cause unwanted bleeding, delay or stoppage of treatment, and reduced graft durability,” said Prabir Roy-Chaudhury, professor of medicine at the Division of Nephrology and Hypertension at the University of North Carolina (Chapel Hill, USA). “I greatly appreciate how this technology is intended to be so patient-centric, addressing this important interface need, for both clinicians and home caregivers.”
innovations across its ischaemic and haemorrhagic portfolios that “reflect the company’s continued commitment to changing the trajectory of stroke”.
Boston announcesScientificacquisition of Obsidio
“So having a graft that has the ability to decrease risk potential and longterm injury is definitely something that would be a game-changer.”
be stuck with two needles three times a week for haemodialysis for 52 weeks, that is 312 times a needle goes into a patient’s graft each year,” said Stephen Hohmann, vascular surgeon at Texas Vascular Associates (Dallas, USA).
Paris Vascular Insights (PVI) 2022 Paris, France parisvascularinsights.com
Society of Interventional Radiology (SIR) Annual Meeting 2023 Phoenix, USA www.sirmeeting.org/index.asp
31 October–3 November 2022
4–9 March
Gore has announced the acquisition of InnAVasc Medical, a privately held medical technology company focused on advancing care for patients with end-stage renal disease who utilise graft circuits for dialysis treatment.
can take time to form an obstruction to blood flow, once placed, the GEM technology conforms to the targeted vasculature, immediately creating a barrier.
is
In addition, Cerenovus debuted an institution-oriented racial disparity in stroke care (RDiSC) metric picklist tool at the booth. According to the release, the RDiSC tool can be used to assess and benchmark a hospital’s stroke outcomes across their patient population by race. The insight derived may be used to uncover areas for improvement in closing the racial disparity gaps that exist along the stroke care
19–23 September 2022
Society of Interventional Radiology (SIR) LEARN and ACTIVE Coronado, USA
Jeffrey Lawson and Shawn Gage from Duke University School of Medicine’s Department of Surgery (Durham, USA) have developed the InnAVasc device, which is specifically designed to allow for safe, easy, reproduceable and durable access for dialysis treatment of patients with graft circuits.
23–25 September 2022
24–26 October 2022
Mediterranean Interventional Oncology (MIO) 2023 Rome, Italy & Digital www.miolive.eu/
Calendar of events
International Symposium on Endovascular Therapies (ISET) 2023 Miami Beach, USA iset.org/2023
Boston Scientific has announced the acquisition of Obsidio, a privately held company that has developed the Gel Embolic Material (GEM) technology used for embolization of blood vessels in the peripheral vasculature.
Cerenovuspathway.alsosponsored multiple programmes and receptions at SNIS 2022, including the Women in Neurointervention Leadership Program; Diversity, Equity and Inclusion Reception; Annual Women in NeuroIntervention Dinner; and Fellows Course Hands-On Lab and Reception.
Recently cleared by the US Food and Drug Administration (FDA), the GEM technology is a semi-solid, proprietary material packaged in a ready-to-use form, thus reducing the preparation time required for many embolization procedures. Physicians deliver the GEM agent through a catheter, and its gel-like composition enables controlled placement within patient anatomy.
Unlike solid and liquid embolics that
Cerenovus supported two scientific poster sessions at SNIS 2022, including one oral presentation on Monday 25 July, entitled “Interim safety and occlusion outcomes of endovascular treatment of ‘very small intracranial aneurysms’ in the STERLING registry”, and one e-poster, entitled “PulseRider-assisted treatment of intracranial aneurysms in the STERLING registry”.
