Outcomes of the Ankura Stent Graft for Endovascular Repair of Infrarenal Abdominal Aortic Aneurysm.

Abstract

The purpose of this retrospective cohort study is to report outcomes of endovascular aortic repair (EVAR) with the novel endograft, Ankura (Lifetech Scientific, Shenzen, China). We identified all patients who underwent elective EVAR with Ankura stent graft in a tertiary unit from January 2015 to November 2021. Patients with ruptured infrarenal and juxtarenal aortic aneurysms were excluded from the study. All patients were anatomically suitable according to the instructions for use (IFU). Follow-up (FU) included computed tomography angiography (CTA) at 1 month, 12 months, and yearly thereafter if endoleak (EL) was not present. Primary outcomes included technical success (primary and secondary) and 30-day overall mortality and morbidity. Secondary outcomes included late overall and aneurysm-related mortality as well as influence of suprarenal fixation of the endograft on renal function at 12 months using eGFR (CKI-EPI formula). The Ankura endograft was successfully implanted in 116 patients (mean age=71.1 years, 96.5% male). Mean aneurysm diameter was 62.3 mm. Median FU was 34 months (2-72 months). Primary and secondary technical success were 95.7% and 100%, respectively. Overall type I EL was 5% (2 proximal, 3 distal) and type II EL was 13%. Thirty days mortality and morbidity were 0% and 5.2%, respectively. All-cause mortality during FU was 13.9% (n=16); aneurysm-related mortality was 2.6% (n=3). Limb endograft patency was 100%. Freedom from reintervention was 98.2% at 2 years, and 97.4% at 4 and 6 years respectively. There was a statistically significant difference between preoperative (73.69 mL/min/1.73 m2) and postoperative (66.66 mL/min/1.73 m2) eGFR at 12 months (p<0.001). Ankura endograft has demonstrated an efficacious durability with low aneurysm-related mortality and high iliac limb patency rate. Elective EVAR is associated with significant decline in renal function at 12 months in our study. Larger series studies are necessary to evaluate long-term safety and efficacy of Ankura endograft. Ankura stent graft is a novel PTFE endograft with suprarenal fixation for infrarenal aneurysm repair. This retrospective cohort study of 116 patients provide a first "picture" of Ankura safety and efficacy in a European tertiary vascular center. High technical success rate, low aneurysm related mortality and high limb patency rate are the main findings of the study with a negative impact of suprarenal fixation on kidney function during follow up.