Effectiveness of additional X-ray protection devices in reducing scattered radiation in radial intervention: the ESPRESSO randomised trial.

AIMS: We aimed to examine the impact of three different radiation protection devices in a real-world setting of radial artery catheterisation. METHODS AND RESULTS: In an all-comer randomised trial, consecutive coronary radial diagnostic and intervention procedures were assigned in a 1:1:1 ratio to shield-only protection (shield group), shield and overlapping 0.5 mm Pb panel curtain (shield+curtain group) or shield, curtain and additional 75x40 cm, 0.5 mm Pb drape placed across the waist of the patient (shield+curtain+drape group). A total of 614 radial procedures were randomised (n=193 shield, n=220 shield+curtain, n=201 shield+curtain+drape). There were no differences among the groups in patient or procedural characteristics. The primary endpoint (relative exposure ratio between the operators' exposure in µSv and the patient's exposure, dose area product in cGy·cm2) was significantly lower in the shield+curtain+drape group for both the first operator (20% reduction vs shield, 16% vs shield+curtain, p=0.025) and the assistant (39% reduction vs shield, 25% vs shield+curtain, p=0.009). CONCLUSIONS: The use of an additional drape reduced the radiation exposure of both the first operator and the second operator during routine radial procedures; a shield-attached curtain alone was only partially effective. ClinicalTrials.gov identifier: NCT03634657

Effectiveness of additional X-ray protection devices in reducing Scattered radiation in radial interventions: protocol of the ESPRESSO randomised trial.

BACKGROUND: A number of devices have been developed to minimise operator radiation exposure in the setting of cardiac catheterisation. The effectiveness of these devices has traditionally been explored in transfemoral coronary procedures; however, less is known for the transradial approach. We set out to examine the impact of three different radiation protection devices in a real-world setting. METHODS AND DESIGN: Consecutive coronary diagnostic and intervention procedures are randomised in a 1:1:1 ratio to a shield-only protection (shield group), shield and overlapping 0.5 mm Pb panel curtain (curtain group) or shield, curtain and additional 75×40 cm, 0.5 mm Pb drape placed across the waist of the patient (drape group).The primary outcome is the difference in relative exposure of the primary operator among groups. Relative exposure is defined as the ratio between operator's exposure (E in µSv) and patient exposure (dose area product in cGy·cm2). ETHICS AND DISSEMINATION: The protocol complies with good clinical practice and the ethical principles described in the Declaration of Helsinki and is approved by the local ethics committee. The results of the trial will be published as original article(s) in medical journals and/or as presentation at congresses. TRIAL REGISTRATION NUMBER: NCT03634657.