Following the first evaluation of exposure to X-rays in interventional neuroradiology and a new multisociety consensus statement on the immediate implementation of enhanced radiation protection for fluoroscopic laboratories, calls for urgent action continue to build across interventional specialties.
Earlier this year, Cathpax—a spinoff of the Lemer Pax group that designs and develops full-body radiation protection systems for interventional medicine practitioners—announced positive results from the NOVARAD clinical study. The study was described as the “first ever” to evaluate exposure to X-rays in interventional neuroradiology, with the aim of assessing the effectiveness of the Nova-X radiation protection system in shielding the entire staff team in cath labs “from head to toe” during interventional procedures.
The multicentre, two-arm prospective NOVARAD study analysed the X-ray doses received by three operators in seven distinct anatomical areas with operational dosimeters measurements as per a minimum detection threshold of 0.1µSv. In total, 178 procedures at four French centres—the university hospitals of Besançon, Bicêtre, Nantes and Toulouse—were included. Some 88 of these procedures were performed with Nova-X compared to 90 without.
The dose received with Nova-X was found to be 11 times lower for the head, 11 times lower for the arms, and 38 times lower for the feet, compared to the conventional approach, according to Cathpax.
In the NOVARAD study, ‘Operator 1’ presented an average dose reduction of 91% across their entire body, with an average value of 1µSv per Nova-X procedure compared to 11.1µSv without Nova-X. The dose for ‘Operator 2’ went from 4.8µSv on average per procedure to 0.8µSv through the use of Nova-X, while ‘Operator 3’ received an average overall dose of 0.4µSv with Nova-X versus 1.1µSv without.
As per attempts to assess the stochastic risk within these data, effective dose was found to be 1.33 without Nova-X and 1.24 with Nova-X in staff members who were not wearing a lead apron. According to Cathpax, obtaining these results alongside deterministic risk findings demonstrating exposure reduction factors greater than 90% over the unprotected anatomical areas validates the possibility of working without a lead apron.
Since the release of the results, Cathpax has since announced the commercial launch of its radiation protection system and aims to have a total of 50 systems installed in the Europe, Middle East and Africa (EMEA) region by the end of 2027.
Although focused a single device using in the neurointerventional space, the NOVARAD results signify increasing interest in a new way of working for many interventionists, with the potential to dispense of lead aprons allowing them to essentially ‘go naked’. Acknowledging this shift, a new multisociety consensus statement has called for hospitals, manufacturers, regulators, and professional societies to immediately adopt enhanced radiation protection technologies, modernise radiation safety standards, and strengthen monitoring and reporting practices to better protect the healthcare teams working in fluoroscopy laboratories.
Jointly published in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI), the Journal of Vascular and Interventional Radiology (JVIR), and JACC: Cardiovascular Interventions, David G Rizik (Banner Health, Scottsdale, USA), chair of the writing group, states that interventionists working in cath labs should “no longer have to accept preventable radiation exposure and orthopaedic injuries at part of their jobs”.
Given the availability of safer technologies, the authors say broader implementation of enhanced radiation protection devices (ERPDs) is both an ethical responsibility and a necessary evolution of ALARA (As Low As Reasonably Achievable)—the longstanding radiation safety standard. ERPDs can reduce radiation exposure through engineering controls rather than relying primarily on personal protective equipment. The consensus statement cites evidence that ERPDs can reduce operator and staff radiation exposure by up to 99%.
The statement proposes several actions to be taken by healthcare organisations and policymakers to improve occupational safety in fluoroscopy laboratories, including: the adoption of ERPDs to reduce radiation exposure; modernisation of safety regulations to reflect today’s technological advancements and evidence; the measurement and reporting of radiation safety performance using real-time dosimetry and quality metrics; the integration of enhanced radiation protection into imaging systems rather than relying on wearable lead; and, the expansion of education, training and research to promote further improvement.
The consensus statement is endorsed by the Society for Cardiovascular Angiography and Interventions (SCAI), the American College of Cardiology (ACC), the American Society of Echocardiography (ASE), the Heart Rhythm Society (HRS), the Society of Interventional Radiology (SIR), and the Society for Vascular Surgery (SVS).
“For decades, we accepted occupational radiation exposure and the physical burden of heavy protective equipment as unavoidable realities of working in a fluoroscopy laboratory,” says Rizik. “That is no longer acceptable. Technologies available today can greatly reduce radiation exposure while also addressing the orthopaedic injuries associated with traditional lead protection. The question is no longer whether these solutions exist. It is whether we are willing to make protecting healthcare workers the priority it deserves. This consensus makes clear that the time for implementation is now.”
Weighing in, interventional radiologist and SIR president Saher S Sabri (MedStar Health, Washington, DC, USA), emphasises that patients depend on them and their teams “for timely access to image-guided treatments that can relieve pain, restore function and save lives”.
“Protecting access to that care means protecting the teams who deliver it,” Sabri continues. “Enhanced radiation protection in the angio suite is not an optional workplace upgrade, but a key component of ensuring patient access to interventional radiology teams who can safely deliver these critical minimally invasive procedures. These guidelines set a clear expectation: safer technology exists, and it should be adopted now.”
Crossing specialty borders, the consensus statement underlines the universal benefit of improving education, adherence to established safety principles, and the implementation of effective enhanced protection technologies for all interventionists. The authors of the consensus affirm that the statement should act as a mandate “grounded in scientific evidence and moral responsibility to safeguard the health of those who have dedicated their professional lives to caring for others in this high-risk environment”, pledging commitment to the “immediate implementation of regulation-mandated enhanced radiation protection”.
