Hitinder S Gurm1, Kreton Mavromatis2, Barry Bertolet3, Dean J Kereiakes4, Amit P Amin5, Atman P Shah6, George S Hanzel7, Siddhartha Rao8, Joseph L Thomas9, Gautam Kumar2. 1. Department of Medicine, Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan. 2. Department of Medicine, Cardiology Division, Atlanta VA Medical Center, Emory University School of Medicine, Decatur, Georgia. 3. Cardiology Associates Research, LLC, North Mississippi Medical Center, Tupelo, Mississippi. 4. Christ Hospital, Heart and Vascular Center, Lindner Research Center, Cincinnati, Ohio. 5. Cardiovascular Division, Washington University School of Medicine, St. Louis, Missouri. 6. Section of Cardiology, University of Chicago Medical Center, Chicago, Illinois. 7. Department of Medicine, Division of Cardiology, William Beaumont Hospital, Heart and Vascular, Royal Oak, Michigan. 8. WakeMed Heart and Vascular, Raleigh, North Carolina. 9. Division of Cardiology, Harbor-UCLA Medical Center, Torrance, California.
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.
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 CKDpatients undergoing CAG and/or PCI results in clinically meaningful CMV savings while maintaining image quality.
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