A Feasibility Study of the DyeVert™ Plus Contrast Reduction System to Reduce Contrast Media Volumes in Percutaneous Coronary Procedures Using Optical Coherence Tomography

Vladislav N. Zimin; Michael R. Jones; Tyler Richmond IV; Jared C. Durieux; Amer M. Alaiti; Gabriel Tensol R. Pereira; Armando Vergara-Martel; Patricia E. Pizzato; Elder I. Zago; Luis A. Dallan; Hiram G. Bezerra

doi:10.1016/j.carrev.2020.09.040

A Feasibility Study of the DyeVert™ Plus Contrast Reduction System to Reduce Contrast Media Volumes in Percutaneous Coronary Procedures Using Optical Coherence Tomography

Vladislav N. Zimin, Michael R. Jones, Tyler Richmond IV, Jared C. Durieux, Amer M. Alaiti, Gabriel Tensol R. Pereira, Armando Vergara-Martel, Patricia E. Pizzato, Elder I. Zago, Luis A. Dallan, Hiram G. Bezerra

Research output: Contribution to journal › Article › peer-review

5 Scopus citations

Abstract

Objective: To evaluate the feasibility of using the DyeVert™ 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/1.73m². 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™ 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.

Original language	English (US)
Pages (from-to)	40-46
Number of pages	7
Journal	Cardiovascular Revascularization Medicine
Volume	30
DOIs	https://doi.org/10.1016/j.carrev.2020.09.040
State	Published - Sep 2021
Externally published	Yes

Keywords

Acute kidney injury
Clear image length
Contrast-induced acute kidney injury
Optical coherence tomography
Percutaneous coronary intervention
Region of interest
Renal insufficiency

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

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10.1016/j.carrev.2020.09.040

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Zimin, V. N., Jones, M. R., Richmond IV, T., Durieux, J. C., Alaiti, A. M., Pereira, G. T. R., Vergara-Martel, A., Pizzato, P. E., Zago, E. I., Dallan, L. A., & Bezerra, H. G. (2021). A Feasibility Study of the DyeVert™ Plus Contrast Reduction System to Reduce Contrast Media Volumes in Percutaneous Coronary Procedures Using Optical Coherence Tomography. Cardiovascular Revascularization Medicine, 30, 40-46. https://doi.org/10.1016/j.carrev.2020.09.040

A Feasibility Study of the DyeVert™ Plus Contrast Reduction System to Reduce Contrast Media Volumes in Percutaneous Coronary Procedures Using Optical Coherence Tomography. / Zimin, Vladislav N.; Jones, Michael R.; Richmond IV, Tyler et al.
In: Cardiovascular Revascularization Medicine, Vol. 30, 09.2021, p. 40-46.

Research output: Contribution to journal › Article › peer-review

Zimin, VN, Jones, MR, Richmond IV, T, Durieux, JC, Alaiti, AM, Pereira, GTR, Vergara-Martel, A, Pizzato, PE, Zago, EI, Dallan, LA & Bezerra, HG 2021, 'A Feasibility Study of the DyeVert™ Plus Contrast Reduction System to Reduce Contrast Media Volumes in Percutaneous Coronary Procedures Using Optical Coherence Tomography', Cardiovascular Revascularization Medicine, vol. 30, pp. 40-46. https://doi.org/10.1016/j.carrev.2020.09.040

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title = "A Feasibility Study of the DyeVert{\texttrademark} Plus Contrast Reduction System to Reduce Contrast Media Volumes in Percutaneous Coronary Procedures Using Optical Coherence Tomography",

abstract = "Objective: To evaluate the feasibility of using the DyeVert{\texttrademark} 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/1.73m2. 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{\texttrademark} 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.",

keywords = "Acute kidney injury, Clear image length, Contrast-induced acute kidney injury, Optical coherence tomography, Percutaneous coronary intervention, Region of interest, Renal insufficiency",

author = "Zimin, {Vladislav N.} and Jones, {Michael R.} and {Richmond IV}, Tyler and Durieux, {Jared C.} and Alaiti, {Amer M.} and Pereira, {Gabriel Tensol R.} and Armando Vergara-Martel and Pizzato, {Patricia E.} and Zago, {Elder I.} and Dallan, {Luis A.} and Bezerra, {Hiram G.}",

note = "Funding Information: The study was partially funded by Osprey Medical, Inc. Wendy Mills, MPH (Saint Paul, MN, USA) provided professional medical editing of this article. Publisher Copyright: {\textcopyright} 2020 Elsevier Inc.",

year = "2021",

month = sep,

doi = "10.1016/j.carrev.2020.09.040",

language = "English (US)",

volume = "30",

pages = "40--46",

journal = "Cardiovascular Revascularization Medicine",

issn = "1553-8389",

publisher = "Elsevier Inc.",

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TY - JOUR

T1 - A Feasibility Study of the DyeVert™ Plus Contrast Reduction System to Reduce Contrast Media Volumes in Percutaneous Coronary Procedures Using Optical Coherence Tomography

AU - Zimin, Vladislav N.

AU - Jones, Michael R.

AU - Richmond IV, Tyler

AU - Durieux, Jared C.

AU - Alaiti, Amer M.

AU - Pereira, Gabriel Tensol R.

AU - Vergara-Martel, Armando

AU - Pizzato, Patricia E.

AU - Zago, Elder I.

AU - Dallan, Luis A.

AU - Bezerra, Hiram G.

N1 - Funding Information: The study was partially funded by Osprey Medical, Inc. Wendy Mills, MPH (Saint Paul, MN, USA) provided professional medical editing of this article. Publisher Copyright: © 2020 Elsevier Inc.

PY - 2021/9

Y1 - 2021/9

N2 - Objective: To evaluate the feasibility of using the DyeVert™ 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/1.73m2. 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™ 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.

AB - Objective: To evaluate the feasibility of using the DyeVert™ 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/1.73m2. 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™ 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.

KW - Acute kidney injury

KW - Clear image length

KW - Contrast-induced acute kidney injury

KW - Optical coherence tomography

KW - Percutaneous coronary intervention

KW - Region of interest

KW - Renal insufficiency

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ER -

A Feasibility Study of the DyeVert™ Plus Contrast Reduction System to Reduce Contrast Media Volumes in Percutaneous Coronary Procedures Using Optical Coherence Tomography

Abstract

Keywords

ASJC Scopus subject areas

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