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

James Sapontis1, Garry Barron1, Sujith Seneviratne1

  • 1Monash Cardiovascular Research Centre, MonashHeart, Monash Health & Department of Medicine (SCS at Monash), Monash University, Melbourne, Australia.

Insights

The DyeVert System significantly reduces contrast media used in coronary procedures by 47%, maintaining image quality. This innovation helps prevent contrast-induced acute kidney injury (CI-AKI) in patients.

Area of Science:

  • Cardiology
  • Medical Devices
  • Interventional Radiology

Background:

  • Contrast media reflux during coronary procedures increases risk of contrast-induced acute kidney injury (CI-AKI).
  • CI-AKI is a significant complication associated with increased morbidity, mortality, and healthcare costs.
  • Reducing contrast volume is a key modifiable factor for CI-AKI prevention.

Purpose of the Study:

  • To evaluate the usability of the DyeVert System.
  • To quantify contrast volume savings achieved with the DyeVert System during coronary procedures.
  • To assess the impact of the DyeVert System on image quality.

Main Methods:

  • A pilot trial involving 44 patients undergoing coronary diagnostic or percutaneous coronary intervention (PCI) procedures.
  • Procedures utilized a manual manifold injection setup with the DyeVert System to divert excess contrast.
  • Direct measurements of attempted versus actual injected contrast volume were recorded.

Main Results:

  • The DyeVert System achieved a mean contrast volume saving of 47% (P < 0.0001), exceeding the 15% target.
  • Similar volume savings were observed in both diagnostic (47% ± 9%) and PCI (50% ± 9%) procedures.
  • Adequate image quality was maintained in 98% of patients (43/44).

Conclusions:

  • The DyeVert System effectively reduces contrast delivery in coronary diagnostic and interventional procedures.
  • The system maintains adequate image quality, crucial for accurate diagnosis and treatment.
  • This technology offers a promising approach to mitigate CI-AKI risk by lowering contrast volume.
Abstract

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