Radiation exposure during cardiac catheterization can result in injury to both the operator and the patient. Operator exposure has been associated with cataract formation [Ciraj-Bjelac O et al. Catheter Cardiovasc Interv 2010] and implicated in brain tumors [Roguin A et al. EuroIntervention 2012]. Skin injury and cancer in patients have been linked to radiation exposure during catheterization as well.

Georgios Christopoulos, MD, Veterans Administration North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, Texas, USA, presented results of the Effect of a Real Time Radiation Monitoring Device on Radiation Exposure During Cardiac Catheterization trial [RadiCure; NCT01510353]. The study objective was to examine the effect of the Bleeper Sv radiation monitoring device on operator and patient radiation exposure during cardiac catheterization. The Bleeper Sv device provides real-time operator dose reporting through auditory feedback. Device feedback enables the operator to take protective measures, such as using radiation only when necessary, repositioning the camera, stepping farther away from the source, or adjusting the lead shielding.

The study included patients undergoing clinically indicated coronary angiography or percutaneous coronary intervention (PCI). A total of 505 patients were randomized to the Bleeper Sv (n = 253) or to the control group (n = 252). The primary end point was operator radiation exposure. Secondary end points were patient radiation exposure, fluoroscopy time, and contrast volume.

Similar proportions of patients in both groups received diagnostic, PCI, and diagnostic + PCI procedures. There were no significant differences in procedural characteristics between the 2 groups (p = .852).

The first operator radiation exposure in the Bleeper Sv group was reduced compared with control for diagnostic procedures (0.7 vs 1.0 millirem [mrem]; p < .001), PCI (1.1 vs 1.4 mrem; p = .323), and both (0.9 vs 1.4 mrem; p < .001), for a 36% relative reduction in overall radiation exposure. The second operator radiation exposure in the Bleeper Sv group was reduced versus control for diagnostic procedures (0.4 vs 0.7 mrem; p < .001), PCI (0.4 vs 0.6 mrem; p = .197), and both (0.5 vs 0.07 mrem; p < .001), for a 29% relative reduction in overall radiation exposure.

There were no significant differences between the Bleeper Sv and control groups in patient air kinetic energy released per unit mass (kerma) for diagnostic procedures (p = .189), PCI (p = .631), or both (p = .153). Nor were significant differences observed between the Bleeper Sv and control groups in patient dose area product radiation dose for diagnostic procedures (p = .269), PCI (p = .511), or both (p = .125). No significant differences were observed in procedural outcomes between the 2 groups.

The Bleeper Sv effect on the first operator exposure remained consistent in various subgroups. The device effect during consecutive periods across the study was consistent, showing that a learning curve was not required.

Limitations of the study included that it was conducted in a single center and that there was no blinding. Additionally, the trial was not adequately powered for differences in patient radiation exposure and did not include a formal protocol for reducing radiation exposure apart from Bleeper Sv use. Dr. Christopoulos concluded that use of the Bleeper Sv device during cardiac catheterization resulted in a 29% to 36% decrease in operator radiation exposure.