Advice
The technology
The technology
DuraGraft is a preservation solution used for storing harvested vessels that will be used for coronary artery bypass grafts (CABG) or peripheral vascular procedures. It can also flush isolated blood vessels harvested through anastomosis. It is a single-use, intraoperative vascular graft treatment to protect the structure and function of the vascular endothelium from ischaemic damage. The technology is also called endothelial damage inhibitor. It is an ionically and pH-balanced physiological salt solution containing L-glutathione, L-ascorbic acid, L-arginine and other additives that protect the graft from the damaging effects of ischaemia and handling during CABG. It is claimed that these have pro-endothelial and pro-vasomotor properties that reduce the incidence of ischaemia reperfusion injury and oxidative damage, while avoiding metabolic storage lesions (biochemical and physiological changes to red blood cells), a pro-coagulant response and inflammation in the harvested graft.
The company notes that DuraGraft includes L-arginine which has been known to cause an allergic reaction in some patients. DuraGraft should not be given to people with known allergy or hypersensitivity to L-arginine.
Innovations
DuraGraft is the only ionically and pH-balanced preservation solution containing antioxidants for vascular grafts to prevent oxidative damage during vascular surgery. The company claims that it is the only approved endothelial damage inhibitor that has been designed to address issues known to happen during grafting, handling, and exposure to ischaemic conditions.
Current care pathway
CABG procedures are often done to improve the blood supply to the heart in people with coronary artery disease to reduce their chances of having a heart attack. CABG might also be used during or after a heart attack to treat blocked arteries. NICE's guideline on stable angina: management provides guidance on treating people with stable angina and revascularisation for people whose symptoms are not satisfactorily controlled with optimal medical treatment. There are 2 main revascularisation procedures used to treat CABG or percutaneous coronary intervention. The choice of revascularisation strategy will depend on many factors including the results of angiography, a patient's preferences, age, and whether they have diabetes or other comorbidities. The use of preservation solution during CABG procedure is not covered by NICE guidance. But, NICE provides guidance on assessing graft patency, including NICE medical technologies guidance on MiraQ for assessing graft flow during CABG and NICE interventional procedures guidance on intraoperative fluorescence angiography for evaluating CABG patency.
In clinical practice, saline or blood-based solutions are commonly used in CABG to store the harvested blood vessels during surgery.
Population, setting and intended user
DuraGraft will be used by cardiac surgeons or nurses in hospital operating theatres, which may be in secondary or specialist tertiary care centres, for people with coronary heart disease.
The company states that no changes are needed to current surgical techniques or procedure.
Costs
Technology costs
DuraGraft costs £630 (including VAT) per CABG. No other consumables are needed according to the company.
Costs of standard care
The 2018/19 national tariff for a CABG ranges from £6,594 (HRG code ED28C, standard CABG with CC score 0 to 4) to £13,547 (HRG code ED26A, complex CABG with CC score of 10 and above). All tariffs include the use of standard storage solutions (saline and blood).
Resource consequences
Using DuraGraft would increase the costs of CABG by £630 per patient. These costs could be offset if the device reduced the incidence of vein graft failure, and if this meant that fewer post-CABG complications and fewer repeat revascularisation procedures were needed.
An economic study abstract (Tatar et al. 2017) estimated the cost of CABG and complications including revascularisation and myocardial infarction, and assessed the cost effectiveness of DuraGraft in CABGs done in Turkey. It took the perspective of the Turkish Social Security Institution. The results suggested that using DuraGraft cost less than not using DuraGraft in CABG, and it was more effective. The predicted number of complications avoided was 2.7, the incremental cost savings were not reported. It is not clear how grafts were stored in the comparator arm of the study.