A Feasibility Study Of The Dyevert (Tm) Plus Contrast Reduction System To Reduce Contrast Media Volumes In Percutaneous Coronary Procedures Using Optical Coherence Tomography

Objective: To evaluate the feasibility of using the DyeVert (TM) Plus EZ Contrast Reduction System in optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) procedures and to assess OCT image quality.Background: OCT is employed as a powerful intravascular imaging modality; however, it requires blood displacement via contrast injection during image acquisition, thereby posing risk of nephrotoxicity. The DyeVert System is designed to reduce and facilitate monitoring of contrast media volume (CMV) delivered, without diminishing image quality.Methods: We conducted a prospective clinical feasibility study to determine whether the DyeVert System is non-inferior to manual contrast injection in reducing CMV without lessening image quality during OCT-guided PCI procedures. Eligible participants were >= 18 years of age, indicated for coronary OCT, and able to provide informed consent. The primary endpoint was CMV saved during angiography; the secondary endpoint was image quality as evaluated by operators in real time and by an independent core laboratory that also assessed images from a control group that underwent comparable procedures performed without the DyeVert System.Results: Fourteen participants underwent 15 coronary OCT procedures using the DyeVert System. Mean age among participants was 67 +/- 11 years, and 11 (78%) were male. Mean eGFR was 71 +/- 20 mL/min/1.73 m(2). Mean attempted CMV administration was 342.01 +/- 129.8 mL; mean CMV delivered was 216.21 +/- 88.87 mL, representing CMV savings of 37.5 +/- 5.3%. Results from quantified OCT analysis suggest that the clear region of interest (ROI) in the DyeVert group was non-inferior (p < .0001) to the control group. There were no device-related adverse events.Conclusions: The DyeVert (TM) Plus EZ Contrast Reduction System reduced CMV and preserved an image quality that was non-inferior to OCT-guided PCI procedures without using the contrast reducing device. (C) 2020 Elsevier Inc. All rights reserved.