Georgios Christopoulos1, Aristotelis C Papayannis1, Mohammed Alomar1, Anna Kotsia1, Tesfaldet T Michael1, Bavana V Rangan1, Michele Roesle1, Deborah Shorrock1, Lorenza Makke1, Ronald Layne1, Rebecca Grabarkewitz1, Donald Haagen1, Spyros Maragkoudakis1, Atif Mohammad1, Karan Sarode1, Daisha J Cipher1, Charles E Chambers1, Subhash Banerjee1, Emmanouil S Brilakis2. 1. From the Department of Cardiovascular Diseases, VA North Texas Healthcare System and University of Texas Southwestern Medical Center, Dallas, TX (G.C., A.C.P., M.A., A.K., T.T.M., B.V.R., M.R., D.S., L.M., R.L., R.G., D.H., A.M., K.S., S.B., E.S.B.); University of Heraklion, Heraklion, Greece (S.M.); Department of Biostatistics, College of Health Innovation, University of Texas at Arlington, Arlington, TX (D.J.C.); and Department of Cardiology, Penn State Hershey Medical Center, Hershey, PA (C.E.C.). 2. From the Department of Cardiovascular Diseases, VA North Texas Healthcare System and University of Texas Southwestern Medical Center, Dallas, TX (G.C., A.C.P., M.A., A.K., T.T.M., B.V.R., M.R., D.S., L.M., R.L., R.G., D.H., A.M., K.S., S.B., E.S.B.); University of Heraklion, Heraklion, Greece (S.M.); Department of Biostatistics, College of Health Innovation, University of Texas at Arlington, Arlington, TX (D.J.C.); and Department of Cardiology, Penn State Hershey Medical Center, Hershey, PA (C.E.C.). esbrilakis@gmail.com.
Abstract
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 theBleeper 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.
RCT Entities:
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.
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