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.
Three specialists were familiar with or had used this technology before. The other 3 specialists had not used the technology before.
All commentators considered DyeVert to be innovative, but 1 commentator advised that it has not been compared with standard care in a randomised controlled and blinded study. A different commentator highlighted that there is a lot of waste from all current contrast injections. One commentator identified a variation of the device available in the US. This variation allows saved contrast media to be reused, which the commentator thought made it a better product. 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.
Commentators identified patients who would particularly benefit, including those with chronic kidney disease, patients with diabetes, and those with heart failure needing invasive cardiac intervention such as percutaneous coronary intervention or transcatheter aortic valve implantation. Furthermore, patients with AKI needing urgent angiography, and patients having long procedures needing large volumes of contrast media (for example, chronic total occlusion [CTO], multivessel percutaneous coronary intervention [PCI]) were thought to benefit. One commentator thought that the device would be particularly useful for new trainees, who tend to inject more contrast. Potential patient benefits included reduced contrast media load, resulting in less CI‑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 media and treating CI‑AKI, less follow-up renal function testing (less repeat blood tests and therefore revisits for patients), 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. Other commentators thought that the resource impact would be reduced from shorter length of stay, and reduced repeat blood tests and potential readmissions. Opinions on costs varied. One commentator thought that DyeVert would cost more than any downstream savings. A second commentator agreed that it would cost more if widely implemented, but if there were strict criteria for us it may become cost neutral in the long term. Other commentators thought that if it was proven to be effective, it could reduce costs, but this cost benefit would need rigorous evaluation from clinical trials. One commentator thought that the device would cost less because it could reduce length of stay. However, another commentator stated they could not comment on costs 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. Two commentators had concerns about image quality with reduced contrast volumes, with 1 commentator stating that this was of most concern with a high body mass index. Commentators suggested that variables such as force of injection, contrast viscosity, guide catheter engagement and patient hydration should be considered. Potential adoption barriers raised by 3 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. Further commentators estimated between 5% and 20% of patients having coronary intervention or angiography would be eligible. One commentator highlighted that this was based on use in patients with stage 3+ chronic kidney disease.
Five commentators identified further research that is needed in the form of randomised controlled blinded trials compared with standard care. One commentator specified research in patients with stage 3+ chronic kidney disease. 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.