Advice
Specialist commentator comments
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.
Four specialists were familiar with or had used this technology before.
Level of innovation
All experts agreed that the technology is a novel concept. Two experts thought DuraGraft is innovative in its formulation, including components that preserve the endothelium of the grafts, and is better than the current standard of care formulations (saline or blood-based solutions). One said that no solution designed specifically for endothelial protection is available in the NHS. One expert thought the technology is innovative and potentially may improve the durability of vein grafts.
Potential patient impact
The potential to improve the patency of vein grafts was the main benefit identified by experts. This was said to minimise vein graft damage during coronary artery bypass graft (CABG) and to reduce vein graft failure after CABG. One expert noted that a retrospective study in the USA has seen a reduction in vein graft dysfunction in people having CABG in the short term, but this would need to be confirmed in the context of randomised controlled trials. Most experts said the technology was unlikely to lead to substantial changes to current care for people having CABG but could improve flow pattern in the short term (4 to 6 weeks) after CABG, and may potentially reduce the need for repeat revascularisations in the long term. Most of the experts agreed that the technology would be of most benefit for patients having CABG using saphenous vein conduits, and especially patients who are prone to early graft failure as 2 experts said.
Potential system impact
The potential to reduce the need for repeat revascularisations was identified as a key benefit to the healthcare system. The possibility of a reduction in vein graft failure and hospital admissions after CABG were also identified by the experts. Two experts said the cost implications of the technology were unclear because of the lack of economic analyses, and thought more evidence was needed to evaluate the cost effectiveness of the technology in the NHS. All experts agreed that there would be little resource impact apart from the cost of the technology, and no extra staff or other equipment would be needed to adopt this technology. Experts thought that minimal training for staff such as theatre scrub nurses would be needed in preparing the technology.
General comments
Two experts noted that DuraGraft has only been used in small number of patients in a trial in the UK. None of the experts were aware of any safety issues however, 1 expert noted a potential risk of allergic reaction to L-arginine included in DuraGraft. The main barriers to adoption identified by 2 commentators were the lack of randomised controlled data on the long-term benefit of the technology and the cost of the technology. Two experts said the technology would become standard care but both noted that the technology would only replace current standard care for graft preservation after harvesting because they did not think the technology was licensed for injection while the vein is being harvested. The company have since confirmed that DuraGraft is licensed for this and they have clarified this point in an updated Instructions For Use approved by their CE-mark Notified Body. One expert thought that the technology would be an addition to the current standard of care.