3.1 NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 8 sources, which was discussed by the committee. The evidence included 2 systematic reviews, 1 non-randomised comparative study, 2 cohort studies, 1 single-arm study that was also included in the systematic reviews, a case report, and a case series of reports from the US Food and Drug Administration Manufacturer and User Facility Device Experience Database. It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in the appendix of the overview.
3.2 The professional experts and the committee considered the key efficacy outcomes to be: prevention of aneurysm rupture and prevention of endovascular aortic aneurysm repair graft migration.
3.3 The professional experts and the committee considered the key safety outcomes to be: bleeding, infection and device migration.
3.4 Patient commentary was sought but none was received.
3.5 The committee was informed that:
The risk of migration with endovascular aortic aneurysm repair (EVAR) is related to the anatomy of the aorta and the choice of endograft.
Using endoanchors in a primary EVAR procedure increases the exposure to X-rays during the procedure.
Endoanchors are difficult to remove.
This procedure is primarily intended to be used for people with unfavourable aneurysm morphology and this is where most of the evidence comes from.
This procedure is also used for people with favourable aneurysm morphology who develop an intraoperative complication such as an endoleak during a primary EVAR. Data collection in this group of people would be helpful.