Minimizing radiographic contrast administration during coronary angiography using a novel contrast reduction system: A multicenter observational study of the DyeVert™ plus contrast reduction system

Abstract

Objective To evaluate contrast media (CM) volume (CMV) saved using the DyeVert™ Plus Contrast Reduction System (DyeVert Plus System, Osprey Medical) in patients undergoing diagnostic coronary angiogram (CAG) and/or percutaneous coronary interventional (PCI) procedures performed with manual injections. Background Current guidelines advocate for monitoring and minimization of the total volume of CM in chronic kidney disease (CKD) patients undergoing invasive cardiac procedures. The DyeVert Plus System is an FDA cleared device designed to reduce CMV delivered during angiography and permit real‐time CMV monitoring. Methods We performed a multicenter, single‐arm, observational study. Eligible subjects were ≥ 18 years old with baseline estimated glomerular filtration rate (eGFR) 20–60 mL/min/1.73 m2. The primary endpoint was % CMV saved over the total procedure. A secondary objective was to evaluate adverse events (AEs) related to DyeVert Plus System or to CM use. Results A total of 114 subjects were enrolled at eight centers. Mean age was 72 ± 9 years, 72% were male, and mean body mass index was 29 ± 5. Baseline eGFR was 43 ± 11 mL/min/1.73 m2. CAG‐only was performed in 65% of cases. One hundred and five subjects were evaluable for the primary endpoint. Mean CMV attempted was 112 ± 85 mL (range 22–681) and mean CMV delivered was 67 ± 51 mL (range 12–403), resulting in an overall CMV savings of 40.1 ± 8.8% (95% CI 38.4, 41.8; P < 0.0001) per procedure. Image quality was maintained in all but one case where the system was turned off for one injection. No DyeVert Plus System‐related AEs were reported. Acute kidney injury (AKI; defined as serum creatinine rise of >0.3 mg/dL from baseline) was reported in 11 cases with seven occurring in subjects with baseline eGFR < 30 and three AKI events were attributed to CM. AKI rates increased as CMV/eGFR ratios increased. Conclusions These data suggest DyeVert Plus System use in CKD patients undergoing CAG and/or PCI results in clinically meaningful CMV savings while maintaining image quality.

DyeVert™ PLUS EZ System for Preventing Contrast-Induced Acute Kidney Injury in Patients Undergoing Diagnostic Coronary Angiography and/or Percutaneous Coronary Intervention: A UK-Based Cost–Utility Analysis

“…Patients at model entry were those undergoing DAG and/or PCI with some kidney function impairment (CKD stage [3][4]. The base-case population was 72 years old [14]. The number of patients undergoing DAG and/or PCI was derived from the NHS reference costs for percutaneous coronary angioplasty (HRG code EY40-EY41) and cardiac catheterisation (HRG code EY42-EY43) [18].…”

“…The number of patients undergoing DAG and/or PCI was derived from the NHS reference costs for percutaneous coronary angioplasty (HRG code EY40-EY41) and cardiac catheterisation (HRG code EY42-EY43) [18]. It was assumed, based on Gurm et al [14], that 26% of these procedures would be DAG combined with PCI.…”

“…Evidence has shown that when DyeVert™ PLUS EZ system is used in patients undergoing DAG and/or PCI, the contrast media volume is significantly reduced [14]. To estimate the reduction in risk of CI-AKI after using DyeVert™, we analysed the CI-AKI rate based on the definition used in the Mehran risk score (i.e.…”

“…The estimated absolute risk reduction was used to adjust the risk of CI-AKI in the intervention arm for the base-case analysis. Alternatively, the absolute risk reduction was estimated using data from Gurm et al [14,19] (Table 1).…”

Protecting the kidneys

“…In this issue of catheterization and cardiovascular interventions (CCI), Gurm et al demonstrate in a multicenter single‐arm observational study that the DyeVert Plus system (Osprey Medical, Inc., Minnetonka, Minnesota) can substantially reduce contrast medium volume, thereby dramatically reducing the potential for acute kidney injury . The system appears to be easy to use, providing immediate feedback to the operator regarding the volume of contrast administered, hence, encouraging the operator to be active in introducing the total volume administered to the patient (Figure ).…”