A first in human evaluation of a novel contrast media saving device

Sapontis, James; Barron, Garry; Seneviratne, Sujith; Fuernau, Georg; Eitel, Ingo; Ledwoch, Jakob; Thiele, Holger; Saad, Mohammed; Waha, Suzanne de; Poess, Janine; Desch, Steffen

doi:10.1002/ccd.27033

Cited by 12 publications

(12 citation statements)

References 17 publications

(12 reference statements)

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“…The DyeVert™ Contrast Reduction System (DyeVert System, Osprey Medical) was cleared by the Food and Drug Administration (FDA) for the purpose of reducing CMV delivered to patients during angiography procedures. Early experience with this device from European centers has demonstrated clinically and statistically meaningful reductions in CM delivered to the patient . We report the results of a single‐arm, observational study evaluating the safety and efficacy of the latest version of the product, DyeVert Plus System, which includes continuous CM threshold monitoring, across multiple participating sites.…”

Section: Introductionmentioning

confidence: 99%

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

Gurm

Mavromatis

Bertolet

et al. 2018

Cathet Cardio Intervent

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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.

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Section: Introductionmentioning

confidence: 99%

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

Gurm

Mavromatis

Bertolet

et al. 2018

Cathet Cardio Intervent

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“…The DyeVert Plus XT System in combination with manual CM injection techniques has been introduced to perform real-time CM dose monitoring and significantly and consistently reduce CM volumes [7,15,20,21]. Corcione et al used the DyeVert Plus for coronary and peripheral applications and found a reduction in applied CM of 41.8 ± 7.3% (95% CI, 37.5 to 46.4; p < 0.05) [20].…”

Section: Discussionmentioning

confidence: 99%

Early clinical experiences with a novel contrast volume reduction system during invasive coronary angiography

Bruno

Nia

Wolff

et al. 2019

IJC Heart & Vasculature

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“…This field has been further extended by the pioneering work of Ali and colleagues who have reported on a series of patients on whom they were able to perform PCI without using any contrast media whatsoever . More recently, studies of the Dyevert system (Osprey Medical Inc., Minnetonka, MN) have demonstrated clinically and statistically significant reductions in the volume of contrast media administered during coronary angiography and/or interventions .…”

Section: Discussionmentioning

confidence: 99%

Contemporary use of and outcomes associated with ultra‐low contrast volume in patients undergoing percutaneous coronary interventions

Gurm

Seth

Dixon

et al. 2018

Cathet Cardio Intervent

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A first in human evaluation of a novel contrast media saving device

Abstract: The DyeVert System substantially decreases contrast delivered to patients during diagnostic or interventional coronary procedures while maintaining adequate image quality. © 2017 Wiley Periodicals, Inc.

Cited by 12 publications

References 17 publications

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

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

Early clinical experiences with a novel contrast volume reduction system during invasive coronary angiography

Contemporary use of and outcomes associated with ultra‐low contrast volume in patients undergoing percutaneous coronary interventions

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