Randomized Evaluation of a Textile-Based Enhanced Radiation Protection Device Versus Control Shielding in the Cardiac...

Occupational radiation exposure remains an inherent risk in cardiac catheterization laboratories. Conventional radiation protection relies on ceiling- and table-mounted shields combined with wearable lead-equivalent personal protective equipment, yet exposure persists and ergonomic burden remains substantial. Enhanced radiation protection devices (ERPD) aim to attenuate scatter radiation at the patient level, but randomized evaluations using comprehensive dosimetry are limited.

In this prospective, single-center, cluster-randomized study, shielding strategies were alternated by week (6 ERPD vs 6 control weeks). A textile-based ERPD (Texray MasterPeace™) was compared with control shielding. Occupational radiation exposure to the first operator and scrub nurse was assessed using a 69-point thermoluminescent dosimetry array worn over personal protective equipment, capturing deep dose equivalent (Hp(10) for operator and scrub nurse roles. The primary end point was weekly cumulative Hp(10) normalized to patient radiation output. Secondary analyses included spatial dose distribution and accumulated Hp(10) over the study period.

A total of 190 procedures were included (ERPD n = 90; control n = 100). Baseline procedural characteristics, including dose area product and fluoroscopy time, were similar between groups. Mean weekly operator Hp(10) was 0.11 mSv with conventional shielding and 0.02 mSv with ERPD (mean difference -0.083 mSv; 95% CI -0.106 to -0.061; P < .001), corresponding to an 78% relative reduction. Scrub nurse exposure was similarly reduced (0.06 vs 0.01 mSv; 77% reduction). Findings were consistent with reductions across all anatomical regions.

In a randomized real-world setting, MasterPeace ERPD substantially reduced occupational radiation exposure for both operators and scrub nurses, supporting its use as an adjunct to conventional shielding.