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

Frontiers in Medicine

article

Giuseppe Tarantini¹  Anand Prasad²  Sudhir Rathore³  Shweta Bansal⁴  Regine Gottfried⁵  Alexander R. Rosenkranz⁶  Carlo Briguori⁷  Mohsen Yaghoubi⁸  Atefeh Mashayekhi⁹  Mehdi Javanbakht⁹  Eoin Moloney⁹ 

[1] Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova;Department of Medicine, Division of Cardiology, University of Texas Health Science Center;Frimley Health National Health Service ,(NHS) Foundation Trust;Department of Medicine, Division of Nephrology, University of Texas Health Science Center;Clinic for General and Interventional Cardiology and Angiology, Herz- und Diabeteszentrum Nordrhein-Westfalen ,(NRW), Ruhr-Universität Bochum;Division of Nephrology, Department of Internal Medicine, Medical University of Graz;Mediterranea Cardiocentro;Mercer University College of Pharmacy;Optimax Access Ltd., Market Access Consultancy, University of Southampton Science Park;Device Access UK Ltd., Market Access Consultancy, University of Southampton Science Park

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

DOI  :  10.3389/fmed.2022.841876

学科分类：社会科学、人文和艺术（综合）

来源: Frontiers

【 摘 要 】

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.

【 授权许可】

CC BY