Efficacy of the RADPAD Protection Drape in Reducing Operators’ Radiation Exposure in the Catheterization Laboratory

  • Wieneke Vlastra
    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.
  • Ronak Delewi
    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.
  • Krischan D. Sjauw
    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.
  • Marcel A. Beijk
    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.
  • Bimmer E. Claessen
    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.
  • Geert J. Streekstra
    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.
  • Robbert J. Bekker
    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.
  • Juliette C. van Hattum
    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.
  • Joanna J. Wykrzykowska
    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.
  • Marije M. Vis
    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.
  • Karel T. Koch
    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.
  • Robbert J. de Winter
    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.
  • Jan J. Piek
    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.
  • José P.S. Henriques
    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.

書誌事項

タイトル別名
  • A Sham-Controlled Randomized Trial

抄録

<jats:sec> <jats:title>Background—</jats:title> <jats:p>Interventional 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.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods and Results—</jats:title> <jats:p> In 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·cm <jats:sup>2</jats:sup> ), 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 ( <jats:italic>P</jats:italic> =0.01) and a 44% relative exposure reduction compared with the use of a SHAMPAD ( <jats:italic>P</jats:italic> <0.001). Use of the SHAMPAD was associated with a 43% higher relative radiation exposure than procedures with NOPAD ( <jats:italic>P</jats:italic> =0.009). </jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions—</jats:title> <jats:p>In 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.</jats:p> </jats:sec> <jats:sec> <jats:title>Clinical Trial Registration—</jats:title> <jats:p> URL: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://www.clinicaltrials.gov">https://www.clinicaltrials.gov</jats:ext-link> . Unique identifier: NCT03139968. </jats:p> </jats:sec>

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