Interventional radiology: Beyond needles and images

Continued from page 2 are just as dependent on imaging as interventional radiologists but would find it impossible to serve their patients well without being able to practise as true clinicians.

Many interventional radiologists do not receive systematic training in all the procedures that they undertake in routine practice, especially the more complex ones. The disproportionate emphasis on diagnostic radiology training precludes the acquisition of sufficient clinical experience. The examination of the European Board of Interventional Radiology (EBIR) under the auspices of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) is a commendable effort but is a ‘voluntary supplemental examination’ which cannot be compared with equivalent tests undertaken by surgeons in their own disciplines. Interventional radiologists could point out that vascular surgeons undertaking IR procedures could be trained better, but that does not excuse the lack of a more robust system of training in IR.

The greatest responsibility for the failure of IR to establish itself as a real clinical specialty lies with institutions responsible for establishing curricula for training and holding examinations. The best decisions in medicine, whether large or small, are taken when considered from the patient’s perspective. Presidents and deans of radiological colleges should imagine that they are lying on a computed tomography (CT) table and are about to have percutaneous ablation of a small renal tumour. They have been asked to choose between two newly appointed staff interventional radiologists available to perform this procedure. One of them had two years of clinical experience, followed by three years of training in diagnostic radiology, which included studying subjects such as the appearance of unusual bone tumours, minutiae of mammography and details of interstitial lung disease. Then, as he was fortunate enough to train in a country where IR is recognised as a subspecialty, he studied this discipline for two years. This was far too short a period to master percutaneous ablation. This would be his first unsupervised procedure. The patient met this person only once, just before entering the CT unit, when informed consent was given. All previous clinical contact was through the patient’s oncologist, who is also going to be responsible for the patient’s care in hospital and the post-procedure follow up–an arrangement that can cause delays and confusion in dealing with recurrent or residual tumour. The second interventional radiologist has followed a curriculum established by a fictional college. After two years’ clinical training, she entered a dedicated course in IR, learning the aspects of imaging relevant to her chosen specialty. She studied, in detail, the procedures and equipment used in IR, and learned clinical skills, assisting her trainers with ward rounds and outpatient clinics. By the time she was appointed as permanent staff, she had carried out 20 percutaneous ablations. A primary clinical specialty of IR should have appropriate supporting staff and facilities, including dedicated CT equipment and other machines specially designed to guide procedures rather than provide images for diagnosis. Sharing CT units between diagnostic and interventional radiologists is as inefficient as running an outpatient clinic in an operating room. A more intense focus on the procedural and clinical skills required in IR would serve patients very well.

Continued from page 1 stakeholders to take action to mitigate the impact of MDR.

Stefan Weber, CEO of Cascination, gave his industry-specific take on the MDR situation to Interventional News. “Cascination started the transition to MDR early on and has already cleared several products under the new legislation. But I am sceptical MDR enhances patient safety as most products themselves do not change. I am certain it decreases innovation through an increased regulatory burden including product up-classification and everexcessive documentation.

“The approach of working with a system of notified bodies (over a central government agency) comes to a limit. On the one hand, different notified bodies potentially classify similar products into different risk classes therefore creating significant distortions in the market. On the other hand, notified bodies are under a significant conflict of interest between their for-profit orientation and their regulatory role. They grow at an alarming rate, with the costs being passed on to manufacturers, to hospitals and eventually to all EU citizens, either as taxpayers or health insurance purchasers.

“The system is largely out of balance; hence several European countries have to, or will, adopt accepting [US] FDA approvals. Manufacturers have stopped considering Europe as an attractive market. Unfortunately, as citizens, and future patients, we will see the full consequences only in a decade from now.”

Pedro Costa, who is CEO of Interventional Systems, also weighed in on his company’s response to the MDR and transition period. “Interventional Systems perspective on the MDR situation when asked by Interventional News, which aligns with those of Pereira et al and Weber. Likening it to “an impending freight train coming down the tracks to a car stuck on the level crossing,” Morgan proceeds to provide context for his concern. “The requirement for medical device companies to secure approval based on data of usage for every single device in their inventory from the simplest guidewire to the most complex thrombectomy device via a very limited number of notified bodies seems unachievable, to say the least. Although originally intended to come into force for new devices next year, the EU seems to have kicked the proverbial can down the road by delaying implementation, but the problems have not gone away, they are just postponed.

“As interventional radiologists, we are already seeing limitations on the availability of devices that we need. It is often difficult to tell whether these are due to supply-side issues (container ships stuck in China, etc) or due to actual withdrawal of devices by companies from the market due to impending MDR. It is likely a combination of both factors. The effects of the MDR will inevitably adversely affect patient safety and patient care by restricting the devices available to interventional radiologists. This will initially impact on the availability of niche devices used in small patient groups.

“To mitigate the effects of withdrawal of devices from the market because of the MDR, interventional radiologists will do as they have always done—i.e. improvise using already-available devices used for other indications to get around problems. However, this is morally wrong in 2023, when we are meant to be improving patient safety, rather than risking it.” has not been affected by the EU MDR challenges. We have been fully compliant since its first deadline, in 2021, and have already developed our secondgeneration robotic platform following the draft text. We have been fortunate as a company because our technological and clinical maturity allowed us to make no compromise on quality and compliance matters. As a Class I device manufacturer, we do not foresee a big impact for our patients and customers. The technology will continue to be available.

In April 2022, MedTech Europe ran a survey of its industry members to assess the planned response to MDR among these companies. The Medical Devices Coordination Group task force on certification capacity monitoring—appointed by the European Commission and comprising members from all EU states— commissioned the survey, whose respondents number 475 companies in and outside the EU. Headline results include that “over half of all respondents plan portfolio reductions” and that those planning portfolio reductions “foresee on average 33% of their devices for discontinuation”.

Furthermore, the report states, “50% of respondents are deprioritising the EU market (or will do so) as the geography of choice for first regulatory approval of their new devices”.

“As for the whole market, the extension is good news. It can alleviate the burden on highly innovative, early-stage companies in the space who would shift their focus to the USA or other fast-paced innovative geographies. And the companies and products will emerge on the other side of the extension better and safer.”

Robert Morgan, consultant radiologist at St Georges NHS Foundation Trust (London, UK) offered his

UK Government acts in response

There is also evidence to suggest that the impact of MDR is anticipated beyond continental Europe, which Morgan’s comment further supports. In February 2023, the UK’s Medical and Healthcare products Regulatory Authority (MHRA) shared in a press release that, currently, a CE-marked device can be placed on the UK market until 30 June 2023, but that “there are plans to extend acceptance of the CE-marking in the UK which, we will put into law in the coming months. We will publish guidance on this as soon as possible.”

In conclusion, the MedTech Europe survey data, and industry and interventional radiologists’ opinions in both continental Europe and the UK, suggest that the future impact that MDR will have is cause for concern. However, some companies, Interventional Systems being an example, have, thus far, been able to navigate the challenges posed by the new and tighter regulations on device safety and quality.

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Johnson, an interventional radiologist and professor of radiology and surgery at Indiana University School of Medicine (Indianapolis, USA) and co-principal investigator on PRESERVE. “PRESERVE showed what questions we should ask as clinicians: ‘does this person continue to require protection against PE, and, in light of changing clinical status and available therapies, is the current filter needed?’ and then make an informed decision on how to continue care.”

David L Gillespie on the PRESERVE trial at VEITHsymposium 2022 “DVTs and PEs are a significant cause of death worldwide and understanding fully how tools like IVC filters can be used to prevent the progression of a DVT into a PE allow physicians to safely treat patients at risk of death from venous thromboembolism [VTE]” said David L Gillespie, a vascular surgeon at Beth Israel Deaconess Medical Center (Brockton, USA), and co-principal investigator on PRESERVE. “Now that the study is complete, we now have a roadmap for better filter utilisation. We need to solidify a clearer set of practice guidelines for venous thromboembolic disease, based on its symptoms, location and complications. Further studies will focus on how the different manifestations of venous thromboembolic disease may benefit from filter-inclusive care.”

Speaking at VEITHsymposium 2022 (15–19 November, New York, USA), Gillespie outlined that “approximately ten years ago or so, the clinical management of patients with VTE and the prophylaxis of potential VTE in trauma patients was not well studied with regard to the use of IVC filters”. The result of the PRESERVE trial has been that “essentially, these filters are safe and effective for therapeutic [and prophylactic] use in the patient population [in question],” Gillespie continued, and this, despite the “challenges” of the COVID-19 pandemic, the “high dropout rate”, and the fact that “a large number of patients” had their filters removed.

PRESERVE and future directions discussed at SIR 2023

The Society of Interventional Radiology 2023 annual scientific meeting (4–9 March, Phoenix, USA), dedicated a session to examining the background, execution, and implications of this study for the future of VTE care. Johnson gave a presentation, of which one of the key takeaways was that, as he sees it, viewing VTE treatment as a question of “anti-coagulation versus filter [is] the wrong way to look at it”. He believes there is more nuance to it—“really, it is [a question of] anti-coagulate when