The impact of the RADPAD in reducing radiation exposure in a contemporary cardiac Cath Lab: Rationale and design of the ATTENUATE trial.

BACKGROUND

Despite recent improvements in radiation safety, interventionalists are increasingly exposed to radiation during cardiac catheterization laboratory (CCL) procedures. The RADPAD was designed as a protective scatter-radiation absorbing shield with the goal of reducing scatter radiation. Early studies demonstrated between a 20 and 62 % relative reduction in scatter radiation. The purpose of this study was to examine the impact of the RADPAD through a randomized controlled trial in a large contemporary CCL.

DESIGN

The ATTENUATE (v) Trial is an investigator-initiated, prospective, randomized controlled trial which will randomize 1000 CCL procedures 1:1 to use of the RADPAD vs. no use of the RADPAD. The primary outcome of interest is the most proximal operator's dose-area product (DAP)-normalized operator dose (E) defined as E divided by DAP. Additional subgroup analysis comparing types of procedure will also be performed. Every case will utilize contemporary radiation safety equipment.

SUMMARY: The ATTENUATE Trial is the largest randomized controlled trial to evaluate the utility of the RADPAD in reducing relative operator exposure in a contemporary CCL including coronary and structural interventions.