Specialist commentator comments
Comments on this technology were invited from clinical specialists working in the field and relevant patient organisations. The comments received are individual opinions and do not represent NICE's view.
None of the 3 specialists were familiar with or had used this technology before.
All commentators considered DyeVert to be innovative with no competing alternatives, although 1 commentator advised that it has not been compared with standard care in a randomised controlled and blinded study. Another commentator noted an alternative system is available and used by some clinicians. The system promotes diuresis and monitor's the patient's urine output to enhance contrast washout from the kidney and prevent contrast-induced acute kidney injury (CI-AKI). However, the commentator acknowledged that DyeVert uses a different method of limiting the contrast load rather than promoting diuresis.
Patients who would particularly benefit include those with moderate to severe pre-existing kidney disease, patients with diabetes and those with heart failure needing invasive cardiac intervention such as percutaneous coronary intervention or transcatheter aortic valve implantation. Potential patient benefits included reduced AKI, reduced costs, reduced morbidity and mortality, reduced need for dialysis and shorter length of stay secondary to less contrast. However, 1 commentator stated that the current evidence does not completely show these improved outcomes and another commentator advised that rates of CI‑AKI may actually be less than historically reported.
System benefits included reduced cost from contrast and treating CI‑AKI, less follow-up renal function testing, less renal replacement therapy, shorter length of stay and potential to increase availability of interventional cardiac procedures for patients with advanced chronic kidney disease. Additional resources included the need for the disposable equipment, for example, tubing and contrast reservoir, and the reusable console for contrast volume monitoring. Opinions on costs varied. One commentator thought that DyeVert would cost more than any downstream savings, whilst another commentator thought that if it was proven to be effective, it could reduce costs. The third commentator could not comment on this because of lack of evidence comparing DyeVert with standard care.
No commentators were aware of any safety concerns. All commentators thought that DyeVert would be used in addition to standard care. One commentator had concerns about image quality with reduced contrast volumes. They suggested that variables such as force of injection, contrast viscosity, guide catheter engagement, patient hydration should be considered. Potential adoption barriers raised by 2 commentators were the cost of the device and patient selection criteria, since it would not be needed for all patients.
Commentators thought that training for the device would be needed to set up DyeVert in the catheter laboratory. This should be a straightforward addition to the manifold system.
It was estimated by 1 commentator that CI‑AKI occurs in up to a third of all at-risk cardiac patients having percutaneous coronary intervention, and so DyeVert may be an option in this patient population.
All commentators identified further research that is needed in the form of randomised controlled blinded trials compared with standard care. Important outcomes would be potential to reduce CI‑AKI, ability to maintain image quality, hospital length of stay and persistent reduction in renal dysfunction. Health economic evaluations would also be needed as evidence.