• Wieneke Vlastra, Ronak Delewi, Krischan D Sjauw, Marcel A Beijk, Bimmer E Claessen, Geert J Streekstra, Robbert J Bekker, Juliette C van Hattum, Joanna J Wykrzykowska, Marije M Vis, Karel T Koch, Robbert J de Winter, Jan J Piek, and Henriques José P S JPS From the Heart Center (W.V., R.D., K.D.S., M.A.B., B.E.C., R.J.B., J.C.v.H., J.J.W., M.M.V., K.T.K., R.J.d.W., J.J.P., J.P.S.H.), Department of Bio.
• From the Heart Center (W.V., R.D., K.D.S., M.A.B., B.E.C., R.J.B., J.C.v.H., J.J.W., M.M.V., K.T.K., R.J.d.W., J.J.P., J.P.S.H.), Department of Biomedical Engineering and Physics and Radiology and Nuclear Medicine (G.J.S.), Academic Medical Center, University of Amsterdam, the Netherlands.
• Circ Cardiovasc Interv. 2017 Nov 1; 10 (11).

BackgroundInterventional cardiologists are increasingly exposed to radiation-induced diseases like cataract and the stochastic risk of left-sided brain tumors. The RADPAD is a sterile, disposable, lead-free shield placed on the patient with the aim to minimize operator-received scatter radiation. The objective of the trial was to examine the RADPAD's efficacy in a real-world situation.Methods And ResultsIn the current, double-blind, sham-controlled, all-comer trial, patients undergoing diagnostic catheterization or percutaneous coronary interventions were randomized in a 1:1:1 ratio to a radiation absorbing shield (RADPAD), standard treatment (NOPAD), or a sham shield (SHAMPAD). The sham shield allowed testing for shield-induced radiation behavior. The primary outcome was the difference in relative exposure of the primary operator between the RADPAD and NOPAD arms and was defined as the ratio between operator's exposure (E in µSv) and patient exposure (dose area product in mGy·cm2), measured per procedure. A total of 766 consecutive coronary procedures were randomized to the use of RADPAD (N=255), NOPAD (N=255), or SHAMPAD (N=256). The use of RADPAD was associated with a 20% reduction in relative operator exposure compared with that of NOPAD (P=0.01) and a 44% relative exposure reduction compared with the use of a SHAMPAD (P<0.001). Use of the SHAMPAD was associated with a 43% higher relative radiation exposure than procedures with NOPAD (P=0.009).ConclusionsIn clinical daily practice, the standard use of the RADPAD radiation shield reduced operator radiation exposure compared with procedures with NOPAD or SHAMPAD. This study supports the routine use of RADPAD in the catheterization laboratory.Clinical Trial RegistrationURL: https://www.clinicaltrials.gov. Unique identifier: NCT03139968.© 2017 American Heart Association, Inc.

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