Anatomic feasibility of the WeFlow-JAAA endograft system for treating juxtarenal and pararenal abdominal aortic aneurysms

Abstract

Abstract This study aimed to evaluate the anatomic feasibility of a novel off-the-shelf device (modular endograft with superior mesenteric artery fenestration, celiac scallop, and bilateral renal inner branches) designed for the treatment of juxtarenal and pararenal abdominal aortic aneurysms (AAAs). Digital computed tomography angiograms were analyzed from 170 consecutive patients with juxtarenal or pararenal AAAs who participated in imaging screening for a national multicenter clinical trial assessing the effectiveness of the WeFlow-JAAA system between February 2022 and January 2024. Anatomic feasibility was evaluated in accordance with the investigational protocols and the instructions for use. A proximal seal of ≥ 20 mm was achieved in 98.2% of patients, and renovisceral artery incorporation was observed in 73.5% (125/170) of cases. According to the conservative instructions for use (IFU) criteria, anatomic feasibility was achieved in 34.7% (95%CI: 27.5%~41.9%) of patients. When applying the liberal IFU criteria, the suitability rate increased to 64.1% (95%CI: 56.8%~71.4%), with configurations A and B being suitable for 56.5% and 60.6% of cases, respectively. The WeFlow-JAAA endograft system exhibits a suitability rate of 64.1% for treating JRAAAs and PRAAAs with a healthy sealing zone of at least 5 mm below the SMA within the Chinese population. Nevertheless, the current design does not optimally allow for the incorporation of renovisceral arteries, indicating a need for further technical research in this domain.