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

Giuseppe Tarantini; Anand Prasad; Sudhir Rathore; Shweta Bansal; Regine Gottfried; Alexander R Rosenkranz; Carlo Briguori; Mohsen Yaghoubi; Atefeh Mashayekhi; Mehdi Javanbakht; Eoin Moloney

doi:10.3389/fmed.2022.841876

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

Front Med (Lausanne). 2022 Apr 25:9:841876. doi: 10.3389/fmed.2022.841876. eCollection 2022.

Authors

Affiliations

¹ Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padua, Italy.
² Department of Medicine, Division of Cardiology, University of Texas Health Science Center, San Antonio, TX, United States.
³ Frimley Health National Health Service (NHS) Foundation Trust, Camberley, United Kingdom.
⁴ Department of Medicine, Division of Nephrology, University of Texas Health Science Center, San Antonio, TX, United States.
⁵ Clinic for General and Interventional Cardiology and Angiology, Herz- und Diabeteszentrum Nordrhein-Westfalen (NRW), Ruhr-Universität Bochum, Bad Oeynhausen, Germany.
⁶ Division of Nephrology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
⁷ Mediterranea Cardiocentro, Naples, Italy.
⁸ Mercer University College of Pharmacy, Atlanta, GA, United States.
⁹ Optimax Access Ltd., Market Access Consultancy, University of Southampton Science Park, Hampshire, United Kingdom.
¹⁰ Device Access UK Ltd., Market Access Consultancy, University of Southampton Science Park, Hampshire, United Kingdom.

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.

Publication types

Systematic Review