The UK’s National Institute for Health and Care Excellence (NICE) Healthcare guidance and standards body, has published positive final medical technology guidance on the use of vascular device company Jotec’s E-vita open plus endoluminal stent graft device in the treatment of complex aneurysms and dissections of the thoracic aorta, in a carefully selected group of people.
An aneurysm is a bulge in a blood vessel that’s caused by a weakness in the blood vessel wall. If an aneurysm ruptures, the resulting haemorrhage can be fatal. Dissections of the thoracic aorta occur when the artery is damaged, and a tear occurs in its weakened wall. Blood then flows in between the layers of the artery wall, and left untreated this could press on other blood vessels or rupture, causing death.
When a complex aneurysm is identified a two stage repair operation is sometimes required because of the extent of disease or damage affecting their aorta. The newly issued NICE guidance says using the E-vita Open Plus device could remove the need for a second procedure and the associated risk of serious complications.
E-vita open plus (pictured) is a stented graft that consists of two sections, allowing two areas of damaged aorta to be treated in one procedure. The proximal segment is crimped identical to conventional vascular graft prostheses while distally the vascular graft is supported by nitinol springs sewn to the polyester tube. The crimped proximal vascular graft segment serves as a connection for vascular reconstruction of the aortic arch. The supported elephant trunk section allows repair of the descending aorta during the first stage procedure avoiding a second stage intervention.
Once in place, the blood flows through the device, instead of into the aneurysm or the tear in the wall of the aorta. The device can also replace part of the aorta if it is badly damaged. The blood in the aneurysm or the damaged wall of the aorta eventually forms a clot, posing no further risk.
By obviating the need for a second operation, the risk of complications is reduced, outcomes for patients are improved and there are anticipated savings associated with using the device compared to standard two stage procedures.
Savings are generated from around two years after the procedure using E-vita open plus. At 10 years after the procedure estimated savings range from just under £22,000 to around £28,000 per patient compared with current practice.
Professor Carole Longson, Director of the NICE Centre for Health Technology Evaluation, said: “This final guidance supports the NHS using the E-vita open plus for treating complex aneurysms (bulging blood vessels) and tears in the wall of the aorta. When used in a carefully selected group of people who may have extensive disease or damage affecting their aorta, the device is estimated to potentially save the health service up to £28,000 per patient over 10 years compared to standard management. As a second surgical procedure would be avoided by using the E-vita open plus, this device is good news for the patient as well as the NHS.”
The medical technology guidance for the E-vita open plus is available here.