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Lead-free shield reduces radiation exposure in cath lab
New data indicate that cardiologists’ radiation exposure in the cath lab is significantly lower with the use of a radiation-absorbing shield, compared with conventional safety measures.
In a double-blind, sham-controlled, all-comers trial, researchers evaluated the effect of the sterile disposable, lead-free protective shield (RADPAD 5100A-O, Worldwide Innovations and Technologies) on reducing radiation exposure for operators performing diagnostic catheterization or PCI.
From January to May 2017, 766 consecutive patients undergoing coronary angiography or PCI were randomly assigned to the protective shield, conventional safety measures or sham shield. The inclusion of a sham shield accounted for shield-induced radiation behavior, which was potentially related to the presence of a radiation protective device, the researchers noted.
Results linked the use of the protective shield to a 20% reduction in the primary outcome of relative operator exposure, compared with that observed with conventional safety measures (P = .01), and a 44% reduction in relative exposure compared with use of a sham shield (P < .001). The researchers also found a 43% higher relative radiation exposure with the use of a sham shield vs. conventional safety measures (P = .009).
“Relative operator exposure is strongly variable between procedures because it is the direct consequence of unmeasurable operator behavior characteristics, such as distance to the scatter radiation source. Consequently, there is a large standard deviation of the primary outcome in all 3 study arms,” the researchers wrote.
“It is hypothesized that the presence of a radiation protection shield such as the RADPAD induces a sense of security and may reduce the operator’s tendency to maintain an appropriate distance from the scatter radiation produced by the patient,” the researchers added, noting that the false sense of security in the sham-shield group may explain why the protective shield was associated with a significantly higher relative exposure reduction with sham shield vs. conventional safety measures.
Data also showed that radiation exposure was slightly lower for the primary operator in the protective-shield group than in the conventional-safety-measures group (P = .11) and significantly lower than in the sham-shield group (P = .001).
In subgroup analyses, relative operator exposure was 60% lower with the protective shield vs. the sham shield in patients with BMI greater than 30 (P = .03) and 33% lower in patients with BMI lower than 30 (P < .001). Additionally, relative operator exposure was 58% lower with the protective shield vs. the sham shield during interventional procedures (P = .001) and 31% lower with the protective shield vs. the sham shield during coronary angiography (P = .005). Relative exposure was also 35% lower during femoral access (P = .09) and 45% lower during radial access with the protective shield vs. the sham shield (P < .001).
“The present large-scale, sham controlled, double-blind, randomized trial resembling real-world clinical practice supports the use of RADPAD, a disposable shield, in addition to conventional radiation protection devices, during diagnostic coronary angiographies and PCIs,” the researchers wrote. – by Melissa Foster
Disclosure: The authors report no relevant financial disclosures.