BS-400-07 REDEFINE-EP: A PROSPECTIVE, RANDOMIZED EVALUATION OF THE CONTROLRAD SYSTEM TO REDUCE RADIATION EXPOSURE DURING CARDIAC ELECTRONIC IMPLANTABLE DEVICE PROCEDURES

Abstract

The ControlRad (CR) system utilizes a dynamic collimator that allows high resolution imaging in an operator-selected region of interest, with significant radiation dose reduction for the remaining field of view. The aim of this study was to evaluate the effectiveness of the CR system to reduce scatter radiation during cardiac electronic implantable device (CEID) procedures. In a prospective, single center study, 90 patients undergoing simple (single or dual chamber CEID) or complex (left bundle pacing and biventricular CEID) procedures were randomly assigned to undergo the procedure with or without the CR system (CR= 43, No CR=47). The primary study endpoint was the scatter radiation dose to the primary operator measured using a standard aluminum oxide badge and a real-time radiation dosimeter badge. Secondary endpoints included the radiation dose to the secondary operator and nurse anesthetist, and dose-area product (DAP). Of the 90 patients, 60 (67%) underwent simple and 30 (33%) underwent complex CEID procedures. For the primary operator, the mean radiation dose at the thyroid position per case was 63% lower in the CR arm (standard badge: 56 vs. 23 μSv). For the second operator, the thyroid dose was also lower in the CR arm (9 vs. 2 μSv, 81% reduction). The cumulative radiation dose for the nurse anesthetist was too low to report meaningful data. The median DAP was 68% lower in the CR arm (622 vs 196 μGym2). Using the real-time radiation dosimeter badge, relative reduction in radiation dose for the primary operator was similar in simple (57%) and complex (60%) procedures (Figure 1). The mean procedure times were similar in CR vs. noCR (71 vs 66 mins, p=0.6). There was no difference in complications between study arms (p=0.19). The ControlRad system effectively reduces scatter radiation exposure to the operators and patient during CEID procedures without prolonging procedure times or complications.