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. 2022 Apr 25:9:841876.
doi: 10.3389/fmed.2022.841876. eCollection 2022.

DyeVert Contrast Reduction System Use in Patients Undergoing Coronary and/or Peripheral Angiography: A Systematic Literature Review and Meta-Analysis

Giuseppe Tarantini  1 , Anand Prasad  2 , Sudhir Rathore  3 , Shweta Bansal  4 , Regine Gottfried  5 , Alexander R Rosenkranz  6 , Carlo Briguori  7 , Mohsen Yaghoubi  8 , Atefeh Mashayekhi  9 , Mehdi Javanbakht  9   10 , Eoin Moloney  9
Affiliations

DyeVert Contrast Reduction System Use in Patients Undergoing Coronary and/or Peripheral Angiography: A Systematic Literature Review and Meta-Analysis

Giuseppe Tarantini et al. Front Med (Lausanne). .

Abstract

Background: Contrast-associated acute kidney injury (CA-AKI) is an important adverse effect associated with injecting iodinated intra-arterial contrast media (CM) during coronary angiography. The DyeVert™ Contrast Reduction System is a medical device intended to reduce the intra-arterial CM volume (CMV) administered. The aim of this study was to assess DyeVert System clinical effectiveness and safety by implementing a systematic review and meta-analysis of existing evidence.

Methods: Systematic electronic literature searches were conducted in MEDLINE, Embase, the Cochrane Database of Systematic Reviews, ClinicalTrials.gov, and the International Clinical Trials Registry Platform database. Relevant data were extracted from included studies and meta-analyses were performed to synthesize evidence across studies.

Results: The review included 17 eligible studies involving 1,731 DyeVert System cases and 1,387 control cases (without the use of DyeVert). Meta-analyses demonstrated use of the DyeVert System reduced CMV delivered to the patient by 39.27% (95% CI, 36.10-42.48%, P < 0.001), reduced CMV/baseline renal function ratios (Hedges's g, -0.56; 95% CI, -0.70 to -0.42, P < 0.001) and percentage of cases exceeding the maximum CMV threshold (risk difference -0.31, 95% CI, -0.48 to -0.13, P < 0.001) while maintaining adequate image quality in 98% of cases. DyeVert System cases demonstrated lower CA-AKI incidence vs. controls (absolute risk reduction 5.00% (95% CI, 0.40-9.80%; P = 0.03), relative risk 0.60 (95% CI, 0.40-0.90; P = 0.01) with a pooled estimate of the number needed to treat with the DyeVert System to avoid 1 CA-AKI event of 20.

Conclusion: DyeVert System use significantly reduces CMV delivered to the patient, CMV/baseline renal function ratios, and CA-AKI incidence while maintaining image quality. Accordingly, the device may serve as an adjunctive, procedure-based strategy to prevent CA-AKI. Future multi-center studies are needed to further assess effects of minimizing CMV on endpoints such as CA-AKI prevention, incidence of adverse cardiac and renal events, and health care costs.

Keywords: DyeVert System; acute kidney injury; contrast induced nephropathy; contrast media; coronary angiography; meta-analysis; percutaneous coronary intervention; systematic review.

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Conflict of interest statement

EM, AM, and MJ were employees of Optimax Access United Kingdom Ltd., and MY was employee of Optimax Access United Kingdom Ltd. and is now an Assistant Professor at Mercer University. AP, CB, and SB were paid consultants for Osprey Medical Corporation. AR and AP received honoraria from GE Healthcare as a consultant. RG has previously received speaker fees from Shockwave Medical Inc. Osprey Medical provided funding for the professional services of Optimax/Device Access, Wendy Mills Writing LLC, and Vita Medical LLC. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

FIGURE 1
FIGURE 1
PRISMA flow diagram for the systematic review. ICTRP, International Clinical Trials Registry Platform; PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses.
FIGURE 2
FIGURE 2
Contrast media volume use. (A) Forest plot of mean difference in absolute contrast volume (mL) in randomized controlled trials. (B) Forest plot of mean difference in absolute contrast volume (mL) in observational studies. (C) Forest plot of proportion of attempted CMV that was diverted (%) in observational studies.
FIGURE 3
FIGURE 3
Contrast media volume threshold management in the DyeVert group.
FIGURE 4
FIGURE 4
Contrast media volume/baseline renal function ratios. (A) Overall meta-analysis across 6 studies. (B) Meta-analysis for CMV/eGFR ratio < 3. (C) Meta-analysis for CMV/eGFR ratio < 2. (D) Meta-analysis for CMV/eGFR ratio < 1.
FIGURE 5
FIGURE 5
Meta-analysis: Forest plot of image quality in the DyeVert group (Proportion of cases with adequate image quality per physician assessment).
See this image and copyright information in PMC

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