The technology

DyeVert (Osprey Medical Inc) is a non-invasive system designed to reduce the amount of contrast media given during coronary and peripheral angiographies, when a manual or power injection of contrast media is needed. It is designed for patients at risk of acute kidney injury (AKI), including patients with moderate to severe chronic kidney disease, diabetes, and heart failure. By reducing the amount of contrast volume entering the patient's vasculature, DyeVert aims to reduce the risk of contrast induced‑AKI (CI‑AKI).

There are 2 DyeVert models: DyeVert Plus EZ and DyeVert Power XT. The DyeVert Plus EZ system consists of:

  • Disposable module: attaches to any standard manifold configuration, has disposable tubing with different ports each controlled by opening or closing a valve, with a reservoir for storing excess contrast.

  • Disposable smart syringe: connects to manifold to deliver dye injections.

  • Reusable monitor: shows real-time dye delivery.

The DyeVert Plus EZ disposable module is positioned between the manual syringe (smart syringe) and the injection port (manifold). The clinician controls the injection of contrast manually and aspirates using the smart syringe. Excess contrast (approximately 40% of total) not needed for diagnostic or therapeutic purposes is moved from the patient's blood vessels into the reservoir in the device. This reduces the total contrast given while, according to the company, maintaining adequate visual quality. Bluetooth in the module and smart syringe allows wireless communication to the monitor, which gives a real-time display of total contrast given, and total diverted contrast. The monitor is included in the cost of the first set of disposables. Future disposables are provided without the monitor. The monitor is maintained and serviced by the company.

DyeVert Power XT is used for power contrast injections. It consists of:

  • DyeVert Power XT assembly

  • contrast collection bag.

The disposable module is positioned between the power injector (injects the contrast) and the angiographic catheter (to put the contrast media into the vascular system). The sterile waste bag collects diverted contrast. Similarly to the manual injection process, a modifiable valve responds to injection pressure and fluid pathway resistance to maintain a minimum flow rate. There is no reusable monitor for live contrast monitoring and no smart syringe in the DyeVert Power XT system.

Current care pathway

NICE's clinical guideline on acute kidney injury: prevention, detection and management states that increasing volume of contrast agent is a risk factor for AKI. This means that patients who are going to have contrast agents should be assessed for their risk of AKI. Use of iodinated contrast agents in the past week should trigger investigation for AKI. Prevention strategies for patients having iodinated contrast include intravenous volume expansion.

A clinical practice guideline on prevention of CI-AKI also states that before any imaging using iodinated contrast media, risk factors for CI‑AKI should be identified (unless very early imaging outweighs the risk of delaying the procedure). When patients are identified as high risk, this must be discussed with a renal physician to assess whether potential benefit from iodinated contrast outweighs the risk of CI‑AKI. Preventative strategies include use of scanning without iodinated contrast or with the lowest possible volume, and intravenous volume expansion. The Kidney Disease, Improving Global Outcomes (KDIGO) clinical practice guideline for AKI recommends using either iso-osmolar or low-osmolar iodinated contrast media (rather than high-osmolar) in patients at increased risk of CI‑AKI.

The European Society of Urogenital Radiology guidelines on contrast media recommends the lowest dose of contrast medium consistent with a diagnostic result and to use of low or iso-osmolar contrast media. For at-risk patients, the guidelines recommend considering an alternative imaging method without iodinated contrast media or preventative hydration.

Innovations

DyeVert is a non-invasive technology to reduce contrast media, with real-time contrast media dose monitoring. The company claims that DyeVert maintains adequate image quality, and that this is not possible with the current approach of manual slowing of the rate of injection.

Population, setting and intended user

The technology is for adult patients at risk of AKI having coronary and peripheral angiography. An increased risk of AKI is associated with:

  • chronic kidney disease (including those with coexisting diabetes)

  • heart failure

  • renal transplant

  • hypovolaemia

  • increasing volume of contrast agent

  • intra-arterial administration of contrast agent.

DyeVert is for use in a cardiac catheter laboratory by consultant cardiologists, interventional cardiologists or catheter laboratory staff in secondary care. Catheter laboratory staff must set up and prime the DyeVert system before each use. Clinicians can turn DyeVert on or off for contrast agent counting or reduction. The company states that there is no training needed.

Costs

Technology costs

The costs are based on company estimates. The total cost for DyeVert (including disposables) per case is £350.00 (excluding VAT). The system monitor is multi-use and servicing (software maintenance and upgrades) is included in this price. The procedure cost of diagnostic angiography or percutaneous coronary intervention is estimated by the company to be £3,565.90. If DyeVert can reduce the incidence of CI‑AKI and recurrent AKI after the procedure, it could be resource releasing.

The company have posted an economic manuscript of a study they plan to publish in a peer-reviewed journal. The evaluation assesses the DyeVert Plus EZ system based on patients with chronic kidney disease stage 3 to 4 having angiography. If DyeVert reduces the incidence of CI‑AKI, it could reduce the cost of CI‑AKI and related complications in the first 3 months after treatment, and the cost of subsequent disease management. However, the company model is based on a number of assumptions and evidence to support these assumptions is limited.

Resource consequences

DyeVert is currently being used by 5 hospitals in the UK according to the company. The company claims that DyeVert could be resource releasing, by reducing the incidence and adverse events associated with CI‑AKI.

Potential adoption barriers raised by 2 commentators were the cost of the device and defining patient selection criteria, since it would not be needed for all patients.