Safety Evaluation of Unibody Endografts for Abdominal Aortic Aneurysm Repair: A Systematic Review and Meta-Analysis

The unibody bifurcated aortic endograft (AFX/AFX2) has emerged as a treatment option for abdominal aortic aneurysms (AAAs). This systematic review and meta-analysis aimed to evaluate the safety of the unibody endograft.

A literature search was conducted in Cochrane Library, Scopus, Web of Science, and PubMed. Studies assessing the unibody endograft for AAA repair between 2014 and 2023 were included. The defined primary outcomes were the incidences of type I, II, and III endoleaks. The secondary outcomes were access site problems, aneurysm-related mortality, aneurysm rupture, all-cause mortality, aneurysm sac growth, limb occlusion, stent graft migration, and technical success rate.

Fourteen studies including 12 observational studies and 2 randomized controlled trials were included in the systematic review. The meta-analysis included 10 studies with 12,690 patients that reported the measured outcomes, and excluded 4 studies that did not. Type II endoleaks had the highest incidence of 12% (95% confidence interval [CI]: 4-20%), followed by type III endoleaks with an incidence of 3% (95% CI: 1-5%). The incidence of type I endoleaks was 1% (95% CI: 0-2%). A subgroup analysis by follow-up duration showed that type II endoleak incidence was higher after 1 to 2 years of follow-up than 3 to 4 years of follow-up. The incidence of aneurysmal mortality was 2% (95% CI: 0-7%), limb occlusion was 1% (95% CI: 0-1%), stent graft migration was 1% (95% CI: 0-2%), aneurysmal rupture was 6% (95% CI: 2-11%), access site problems were 7% (95% CI: 2-13%), aneurysm sac growth was 2% (95% CI: 0-4%), all-cause mortality was 21% (95% CI: 4-38%), and technical success rate was 100% (95% CI: 98-100%).

The unibody endograft is a safe and minimally invasive approach for AAA repair. However, potential complications necessitate close patient follow-up after the intervention.