A peer-reviewed study published in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI) reports that the Texray MasterPeace enhanced radiation protection device (ERPD) significantly reduced occupational radiation exposure for cardiac catheterization laboratory staff during fluoroscopically guided procedures.
The cluster-randomized controlled trial was conducted independently by researchers at Sahlgrenska University Hospital in Göteborg, Sweden. Over a 12-week period, investigators compared six weeks using the textile-based MasterPeace system with six weeks of conventional radiation shielding. The study measured cumulative radiation exposure using 69 body-worn dosimeters placed on the upper and lower body of both the primary operator and the scrub nurse. Researchers normalized the findings to each patient’s actual radiation output to account for differences in procedure type and complexity.
According to the study authors, the evaluation is among the first randomized studies of an enhanced radiation protection device to use multi-point passive dosimetry under real-world clinical conditions.
“The results are encouraging and come from a well-structured evaluation,” Associate Professor Oskar Angerås, consultant cardiologist at Sahlgrenska University Hospital, said in a statement. “Our aim was to evaluate how the system performs in everyday practice, and to understand how new occupational safety measures might be responsibly integrated.”
Researchers reported that the extrapolated annual occupational radiation exposure, based on a workload of 800 procedures per year, represented only a fraction of the occupational exposure limits established in Europe and the United States. The study reported average exposure per procedure of 1.3 microsieverts (0.13 mrem) for the primary operator and 0.7 microsieverts (0.07 mrem) for the scrub nurse.
“The shielding was highly effective yet enabled us to maintain our usual workflow,” said Associate Professor Truls Råmunddal, senior consultant physician and head of the intervention section in the Department of Cardiology and Thoracic Surgery at Sahlgrenska University Hospital. “These results also indicate that it may be feasible to work with no aprons when using next-generation ERPD systems such as MasterPeace.”
Texray said the findings support the effectiveness of its MasterPeace system, which uses radiation-attenuating textile integrated into table-mounted and patient-mounted shielding to provide protection while maintaining procedural access. The company said the flexible textile design is intended to improve ergonomics, durability and workflow during fluoroscopically guided interventions.
“From day one at Texray, we committed to building a product that would stand up to the most rigorous scrutiny,” Petra Apell, founder and CEO of Texray AB, said in a statement. “This publication is the confirmation of that commitment.”
The study, “Randomized Evaluation of a Textile-Based Enhanced Radiation Protection Device Versus Control Shielding in the Cardiac Catheterization Laboratory,” is available in the Journal of the Society for Cardiovascular Angiography & Interventions.
