The CIRSE Annual Congress is the premier stage for the IR community to share and discuss new and upcoming research in the field of interventional radiology. CIRSE 2024 included two FIRST@CIRSE sessions, in which investigators shared the latest data from their new and ongoing trials, and several hot topic symposia which focused more acutely on some of the most note-worthy issues of the moment.
The first of the two FIRST@CIRSE sessions was held on the Saturday of the congress, enjoying a packed audience in one of the congress centre’s many auditoria. This session focused exclusively on first data releases on vascular IR trials and studies.
Prof. Eric Ducasse opened the session with a presentation on the one-year results from the LUMIFOLLOW registry. The LUMIFOLLOW registry is a prospective, multicentre, consecutive, post-market study aimed to evaluate the performance of Luminor DCB (iVascular) in femoropopliteal lesions of real-world patients with up to five years follow-up. Drug-coated balloons have been a controversial topic in IR over the last few years, but, as Dr. Ducasse concluded, “Again, dear colleagues, real-world data and RCT continue to confirm the long-term clinical safety and efficacy of the Luminor and all the DCBs in femoropopliteal lesions.” Two-year results will be shared next year and a subgroup analysis will follow.
LUMIFOLLOW was not the only trial focusing on drug-eluting balloons presented in the session; Dr. Michael Lichtenberg spoke on the encouraging 6-months results from the SUCCESS PTA study, which evaluates the performance of a novel sirolimus eluting balloon in peripheral arterial disease. Prof. Ulf Teichgräber presented on the SIRONA randomized controlled trial, which compared sirolimus- versus paclitaxel-coated balloon angioplasty in the femoropopliteal artery. The clinical endpoints showed no significant difference in freedom from cdTLR, similar clinical improvements between sirolimus DCB and Paclitaxel DCBs, and nonanterior safety of sirolimus DCBs. Primary efficacy endpoints will be ready for presentation soon.
Prof. Thomas Rand took the stage to present the 36-month results of the MOTIV bioresorbable BTK scaffold pilot study, the primary objective of which is to evaluate the immediate and long-term safety and efficacy of the MOTIV™ Bioresorbable Scaffold (Reva Medical) in below-the-knee arteries for the treatment of patients with rest pain or minor tissue loss (CLI). So far, the results have demonstrated favourable acute safety and effectiveness in this initial trial, with a 99% technical success rate in delivery and revascularization with 80% vessel patency demonstrated in patients through the 36 months.
Prof. Andrew Holden presented the acute outcomes from the Disrupt PAD BTK II Study of the Shockwave intravascular lithotripsy system for treatment of calcified below-the-knee peripheral arterial disease. Procedural outcomes were favourable, with low angiographic complication rates and a significant reduction in residual stenosis.
Prof. Stefan Müller-Hülsbeck gave insights from the ROADSAVER study, which is a real-world study of a dual-layer micromesh stent (DLMS) in elective carotid artery stenosis treatment with the intent to report country-specific practice trends and safety outcomes. The study showed an overall low 30-day major adverse event rate in ‘real-world’ elective CAS both in symptomatic and asymptomatic patients. A variable patient outcome could be observed throughout countries, Prof. Müller-Hülsbeck said, in relation to the experience of the operator and the number of patients per site.
Prof. Mahmood Razavi spoke on the 6-month outcomes of the WAVE study, a prospective, randomized, controlled, multi-centre trial comparing the Wrapsody Cell-Impermeable Endoprosthesis to percutaneous transluminal angioplasty (PTA) for treatment of venous outflow circuit stenosis/occlusion in patients with haemodialysis fistulas or grafts. The results show WRAPSODY to exhibit superior 6-month target lesion primary patency compared to PETA, a higher 6-month access site patency versus PTA, and a similar safety profile to PTA. This study will be ongoing for up to 24 months.
The second FIRST@CIRSE session focused on first data releases from IR trials and studies from various topics.
First in the session, Prof. Bart Dolmatch spoke on the first clinical results from AVeNEW post-approval study. This study intends to confirm the post-market, real-world efficacy and safety performance of the Covera(TM) stent graft compared to the reported results from the AVeNEW Investigational Device Exemption (IDE) Clinical Trial in stenotic lesions of arteriovenous fistulae. The 6-month data from the study confirms the previous findings of the Covera IDE in dysfunctional fistulae and support covered stent use over angioplasty. The study will be ongoing for three years.
Up next, Prof. Hans van Overhagen presented results of the PUCCCINI (PEVAR) trial, which is a prospective, investigator-initiated study in order to assess the safety and effectiveness of PEVAR using the small-sized Cordis Incraft (outer sheath size 14F) stentgraft combined with the Perclose Proglide closure devices. The study concluded that elective PEVAR with Incraft stent graft and Proglide closure devices is safe and effective.
Switching focus to embolization, the session continued with Dr. Mateus Picada Correa’s talk on the 12-month results of the GAUCHO Trial, which is an RTC looking at genicular artery embolization using imipenm/Cilastatin vs. microspheres for chronic knee pain. The trial found that there was an improvement of WOMAC and KOOS pain scores after 3 and 12mFU of GAE with no difference between embolic materials. It favours Embospheres in KOOS sports and symptoms after 12 months. The trial will be submitted in the next weeks.
Dr. Masao Yamamoto Ramos gave a lecture on REPIVAC, the Spanish multicentric registry for the treatment of pelvic varices by embolization with Amplatz type plug. This registry aims to assess the efficacy of Amplatz Vascular Plugs (AVP) in the embolization of pelvic venous axes without major complications in women diagnosed with Pelvic Congestion Syndrome (PCS). Early results showed a technical success rate of 96%, significant pain reduction by twelve months, and low complication rates (18%). These findings could substantially influence interventional radiology practices by providing a minimally invasive treatment option for PCS with fewer complications and similar costs compared to traditional coil embolization.
The last two lectures of the session focused on interventional oncology topics. First, Dr. Bruno Odisio presented the primary results of COVER-All, a randomized, intent-to-treat, phase 3 superiority trial comparing software-aided versus visual inspection of intraprocedural minimal ablative margins of patients with liver tumours undergoing percutaneous thermal ablation. He concluded that software-based assessment significantly improves MAM for liver tumour TA as a continuous and categorical metric. The findings support integrating software-based assessment into standard liver TA care.
Dr. Nicole Varble closed out the session presenting on dual-layer spectral CT as an in Vivo procedural hypoxia biomarker for in woodchuck hepatocellular carcinoma. This study evaluated the ability of spectral CT as a non-invasive biomarker of hypoxia in a heterogenous liver tumour and sought to quantify and characterize oxygen content in naturally occurring hepatocellular carcinomas (HCC) in woodchucks via spectral CT and histopathology. The study concluded that spectral CT imaging may be a helpful, non-invasive tool to characterize tumour heterogeneity and localize levels of hypoxia during HCC interventions, and the results support work related to tissue perfusion and the predictive value of tumour hypoxia as a non-invasive biomarker on spectral CT.
Hot topic symposia at the CIRSE Annual Congress give a platform in which to discuss groundbreaking research, controversial topics, or particularly exciting developments in the world of IR.
One of this year’s best-attended sessions was the hot topic symposium focusing on MSK embolization in 2024. Musculoskeletal embolotherapy is a fast emerging treatment option for many degenerative and sports related conditions – Prof. Mark Little calls it “the next frontier in interventional radiology,” offering hope for millions of patients living with chronic pain. Still, research on the topic is limited, and the placebo effect must be considered in any intervention designed to treat pain.
Prof. Marcus Katoh opened the session speaking on MSK embolization in the knee, guiding attendees through the arterial anatomy, procedural steps, and different embolic options for knee embolization to treat pain. “It’s a straightforward technique with a low risk profile”, he stated, but cautioned that it should still be done by a physician well-experienced in embolic techniques. He stipulated that the long-term results of the technique are limited, and that there remains room for improvement regarding the optimal embolization material.
Up next, Prof. Mark Little built upon Prof. Katoh’s presentation by presenting the current evidence and ongoing trials concerning MSK embolization in the knee. He pointed out the exponentially increasing amount of data since 2015, and that the studies available using different embolics show genicular artery embolization (GAE) is safe and effective with good data concordance. After walking attendees through several studies showing good results, he gave advice on starting a service, cautioning that practitioners should decide early on how to measure outcomes, perhaps with the help of orthopaedic colleagues. As to the future, Prof. Little registered the technique with NICE in 2021, and it is up for a re-review it in October of this year. It is currently recommended as a research-only pursuit, awaiting data from currently ongoing trials and long-term outcomes.
Prof. Anthony Ryan took the stage to speak on the management of painful shoulder conditions via transarterial embolization. He began by debunking the myth that frozen shoulder syndrome is self-limiting; there is no evidence to support the theory of progression through recovery phases to full resolution without treatment. He presented the procedural steps and the anatomy of the shoulder relevant for embolization, as well as a few relevant studies. He cautioned that, though shoulder artery embolization is generally safe and appears effective, the level of evidence is “level three at best, and predominately level four. We need more, clearly.”
Dr. Yuji Okuno closed the session with a talk on MSK embolization for sports injuries, beginning with the flashy statement that two gold medallists and one silver medallist in the 2021 Tokyo Olympics have previously received embolotherapy for overuse sports injuries. He gave an overview of common overuse sports injuries, which can be difficult to manage and currently lack a singular critical treatment option. There are a few unique considerations in high-level sports overuse injuries; namely, that the injury happens over time, rather than after a single incident, and that athletes want to return to activity – and the possibility of re-injury – as soon as possible. He presented the outcomes after embolization from his own practice, which have been positive, and implored that high-quality scientific studies are still needed to increase awareness and acceptance of the technique.
Hot topic symposia also took place on interventional oncology, aortic, and IR management topics.
These and all other sessions from CIRSE 2024 continue to be available on demand via CIRSE Library!
