Efficacy of the SEPARPROCATH® radiation drape to reduce radiation exposure during cardiac catheterization: A pilot comparative study

Abstract

Background: Interventional cardiologists are exposed to radiation-induced diseases, partly due to patient's scatter radiation.

Objectives: We sought to compare the radiation exposure (RE) of the cardiac catheterization room staff using SEPARPROCATH®, a novel radio-protective drape versus standard shielding equipment.

Methods: This was a two-step prospective, randomized pilot trial: first, in experimental conditions using a phantom model, and second, during cardiac catheterization. Primary end-point was operator RE corresponding to the ratio between operator cumulative dose (CD) and dose area product (DAP). Secondary end-points were nurse RE, operator and nurse CD, DAP, and fluoroscopy time.

Results: A total of 51 patients were included. SEPARPROCATH® was associated with a lower operator RE (0.07 [0-0.19] vs. 0.37 [0.23-0.81] μSv/Gy.cm² without SEPARPROCATH®, p value <0.0001) and lower nurse RE (0 [0-0.05] vs. 0.13 [0.03-0.28] μSv/Gy.cm² , p value <0.0001) corresponding to an RE relative risk reduction of 81% and 99%, respectively. Similar reductions were observed for operator and nurse CDs. No difference was found in DAP (19 [11-29] vs. 14 [10-32] Gy.cm² without SEPARPROCATH®, p value 0.81).

Conclusion: SEPARPROCATH® offers significant additional radioprotection to the operator and nurse during cardiac catheterization without affecting patient safety.

Keywords: innovation; interventional cardiologist; percutaneous coronary intervention; radiation exposure; radiation protection.