Effect of a real-time radiation monitoring device on operator radiation exposure during cardiac catheterization: the radiation reduction during cardiac catheterization using real-time monitoring study.

BACKGROUND: The Radiation Reduction During Cardiac Catheterization Using Real-Time Monitoring study sought to examine the effect of a radiation detection device that provides real-time operator dose reporting through auditory feedback (Bleeper Sv; Vertec Scientific Ltd; Berkshire, UK) on patient dose and operator exposure during cardiac catheterization. METHODS AND RESULTS: Between January 2012 and May 2014, 505 patients undergoing coronary angiography, percutaneous coronary intervention, or both were randomized to use (n=253) or no use (n=252) of the Bleeper Sv radiation monitor. Operator radiation exposure was measured in both groups using a second, silent radiation exposure monitoring device. Mean patient age was 65±8 years, most patients (99%) were men, and 30% had prior coronary artery bypass graft surgery. Baseline clinical characteristics were similar in the 2 study groups. Radial access was used in 18% and chronic total occlusion percutaneous coronary intervention constituted 7% of the total procedures. Median procedure time was 17 (12-27) minutes for diagnostic angiography, 42 (28-70) minutes for percutaneous coronary intervention, and 27 (14-51) minutes in the overall study population, with similar distribution between the study groups. First (9 [4-17] versus 14 [7-25] µSv; P<0.001) and second (5 [2-10] versus 7 [4-14] µSv; P<0.001) operator radiation exposure was significantly lower in the Bleeper Sv group. Use of the device did not result in a significant reduction in patient radiation dose. The effect of the Bleeper Sv device on operator radiation exposure was consistent among various study subgroups. CONCLUSIONS: Use of a real-time radiation monitoring device that provides auditory feedback can significantly reduce operator radiation exposure during cardiac catheterization. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01510353.