Impact of Radiation-Attenuating Drape on Exposure in a Contemporary Cardiac Catheterization Laboratory: The ATTENUATE Trial.

BACKGROUND: Despite recent improvements in radiation safety, interventionalists are increasingly exposed to radiation during cardiac catheterization laboratory (CCL) procedures. The RADPAD was designed as a protective scatter-radiation absorbing shield with early studies demonstrating a 20% to 62% reduction in scatter-radiation. The objective of this study was to examine the impact of the protective scatter-radiation absorbing shield in a large contemporary randomized controlled trial across multiple CCL procedures. METHODS: The investigator-initiated, prospective, randomized, controlled ATTENUATE (rAdpad proTecTion drapE iN redUcing rAdiaTion Exposure) trial randomized CCL procedures 1:1 to use of the RADPAD vs no use of the RADPAD. The primary outcome of interest was the most proximal operator's dose area product (DAP)-normalized operator dose (E). RESULTS: A total of 1000 CCL procedures were randomized 1:1 to use of the protective scatter-radiation absorbing shield (n = 500) vs no use (n = 500). The use of the protective scatter-radiation absorbing shield was associated with a 45.1% relative reduction in the DAP-normalized operator dose compared with no use of the protective scatter-radiation absorbing shield (0.64 vs 0.35 μSv/Gy⋅cm2; P < .0001). Coronary cases (n = 720) saw a 21.9% relative reduction in the DAP-normalized E using the RADPAD (0.33 vs 0.43 μSv/Gy⋅cm2; P < .001), and structural cases (n = 210) saw a 54.4% relative reduction in the DAP-normalized E using the RADPAD (0.30 vs 0.66 μSv/Gy⋅cm2; P = .1094). CONCLUSIONS: In the largest randomized controlled trial to date evaluating the RADPAD protective scatter-radiation absorbing shield, encompassing contemporary coronary and structural CCL procedures, use of the protective scatter-radiation absorbing shield led to a marked decrease in proximal operator radiation exposure when adjusted for the total radiation delivered during each procedure.