Endovascular stent-grafts for the treatment of abdominal aortic aneurysms: NICE technology appraisal guidance

Abstract

This technology appraisal guidance should be read in conjunction with the NICE interventional procedure guidance on stent-graft placement in abdominal aortic aneurysm (interventional procedure guidance 163). 2 EVAR is recommended as a treatment option for patients with unruptured infra-renal abdominal aortic aneurysms, for whom surgical intervention (open surgical repair or endovascular aneurysm repair) is considered appropriate.The decision on whether EVAR is preferred to open surgical repair should be made jointly by the patient and his/her clinician after assessment of a number of factors including: c aneurysm size and morphology c patient age, general life expectancy and fitness for open surgery c the short-term and long-term benefits and risks of the procedures including aneurysm-related mortality and operative mortality. EVAR should only be performed in specialist centres by clinical teams experienced in the management of abdominal aortic aneurysms and with appropriate expertise in all aspects of patient assessment and the use of endovascular aortic stent-grafts.Endovascular aortic stent-grafts are not recommended for patients with ruptured aneurysms except in the context of research. DEVELOPMENT OF THE GUIDANCEThe appraisal committee first considered the evidence on the clinical effectiveness of EVAR for the treatment of unruptured infra-renal abdominal aortic aneurysms. Four randomised controlled trials (RCTs) were identified 3-8 comparing EVAR with open surgical repair (OSR) and three registries, 9-14 which indicated that EVAR had benefits in terms of reduced rates of operative and aneurysmrelated mortality in the medium term. However, these findings were not accompanied by a reduction in all-cause mortality and were associated with increased rates of complications and reinterventions for EVAR compared with OSR.Evidence from clinical specialists indicated that the RCTs included in the analyses had used older stent-grafts, and that these stent-grafts had significantly improved since the RCTs were carried out. In addition, clinical expertise both in assessing patients' suitability for EVAR and in undertaking the procedure had improved with more widespread use of EVAR and therefore the rates of long-term aneurysm-related death, complications and reintervention following EVAR currently seen in UK clinical practice was lower than those shown in the RCTs. The appraisal committee was therefore persuaded that the benefits of EVAR compared with OSR in current UK clinical practice were likely to be greater than those seen in the RCTs.Evidence to support possible differences in the clinical effectiveness of the different types of stentgrafts was also considered. Only two of the five endovascular stent-grafts (Zenith and Talent) had been compared head-to-head in RCTs, 15 and these studies showed no statistically significant differences between these stent-grafts. Additionally, clinical specialists provided testimony that different stent-grafts were considered clinically comparable and that, in practice, any of the e...

Aortic aneurysm: awareness, causes and management

“…Age and sex: Increasing age and the male sex have been shown to increase the risks of AAA, TAA and aortic dissection, (Forsdahl et al, 2009;Landenhead et al, 2015). In men the incidence of AAA is approximately 25 per 100,000 at age 50, increasing to 78 per 100,000 in those older than 70 years, (Hay et al, 2009). This is compared to a much lower prevalence in women, 13 per 100,000 aged over 65, (Scott et al, 2002).…”

Abdominal aortic aneurysms

“…It has been shown in men that the incidence is approximately 25 per 100,000 at age 50 increasing to 78 per 100,000 in those older than 70 years, (Hay et al, 2009). In a 2001 study, the mean age of patients undergoing repair for AAA in the United States was 72 years, (Huber et al, 2001).…”

“…Conventional (open) surgical repair involves making a large incision in the abdomen and inserting a prosthetic graft to replace the damaged section of the aorta, (Hay et al, 2009). Endovascular aneurysm repair (EVAR) is where a thin tube is passed via the blood vessels into the groin to the site of the AAA.…”

“…The decision as to which treatment is most appropriate is a complex one and should be made jointly by the patient and their clinician after assessment of a number of factors, (Hay et al, 2009). Including:…”

Survival Following Endovascular Aneurysm Repair in the Octogenarian

“…On one hand, we recognize increasing age as an independent predictor of mortality, postoperative complications, and the need for discharge to an extended care facility for both treatment options of AAA, open and Endovascular Aneurysm Repair (EVAR) not to mention the limited potential in remaining life years [3,4]. On the other hand, current evidences through randomized controlled trials do suggest safe EVAR use in octogenarians [5][6][7][8]. Although some controversies do remain regarding the generalisability of these evidences, this is enough to cause split opinions amongst field experts.…”