Wearing a bleeper device during catheterizations helped lower radiation exposure to operators by about one third in the RadiCure Study. Results from the late-breaking randomized controlled clinical trial were presented May 30 at the Society for Cardiovascular Angiography and Interventions (SCAI) scientific session in Las Vegas.
The RadiCure (RAdiation reDuctIon during Cardiac Catheterization Using Real timE monitoring) study evaluated the effectiveness of a bleeper device that monitors radiation dose and provides feedback in real time to the operator. The device bleeps at 15-minute intervals when background radiation remains in a normal range but will increase in frequency and intensity if radiation increases.
“We hypothesized during heart procedures (it) would result in significant reductions of exposure for both patients and operators,” said Georgios Christopoulos, MD, research fellow at VA North Texas Health Care System and the University of Texas Southwestern Medical Center in Dallas, at a news conference.
The study enrolled and randomized 505 patients between 2012 and 2014 with a primary outcome of operator radiation exposure and a secondary outcome of patient radiation exposure, fluoroscopy time and contrast administration. In one group, operators wore the Bleeper Sv (Vertec Scientific). Both groups had operator radiation exposure measured with a second, silent monitoring device.
The patient arms were generally similar, as were the proportion of femoral and radial procedures and procedure times.
Operator exposure was significantly lower in the bleeper group compared with the control group, at 0.9 mrem vs. 1.4 mrem for the first operator and 0.5 vs. 0.7 mrem for the second operator. That translated into a 36 percent relative reduction for the first operator and a 29 percent relative reduction for the second operator.
“This was consistent for diagnostic catheterizations, PCI catheterizations and catheterizations overall,” he said.
Patient radiation exposure was lower in the bleeper group, for a relative reduction of 9 percent, but it was not statistically significant.
They also looked at trends over time to assess for a learning curve and found none, “implying that there is no necessary training required to use the device,” he said.
The study did not require physicians to follow a specific protocol in response to a bleep, though.
“All operators were instructed to have a behavior modification after the bleep sound,” Christopoulos explained, such as reducing fluoroscopy dose, using radiation-absorbent drapes and repositioning themselves. “However, one of the limitations of the bleeper study was there was no formal protocol mandated as to the course of action.”