Outcome Comparison of Asymptomatic Juxtarenal Aortic Aneurysms Treated With the Off-the-Shelf P-branch Device and Custom-manufactured Fenestrated-branched Devices

Abstract

To compare the performance between the Zenith p-branch device and custom- manufactured devices (CMD) for the treatment of asymptomatic juxtarenal aortic aneurysms (JRAA). A single-center retrospective analysis of prospectively collected data was performed. Patients with diagnosis of JRAA submitted to endovascular repair between July 2012 and November 2021 were included in the study, being divided into two groups: CMD and Zenith p-branch. The following variables were analyzed: preoperative information (demographics, comorbidities, and maximum aneurysm diameter); procedural data (contrast volume, fluoroscopy time, estimated blood loss, and technical success); and postoperative data (30-day mortality, duration of ICU and hospital stay, major adverse events, secondary interventions, target vessel instability, and long-term survival). From a total of 373 CMD cases performed in our institution, 102 patients presented the diagnosis of JRAA. Of these, 14 patients were treated with the p-branch device (13.7%) and 88 (86.3%) with a CMD. Both groups presented similar demographic composition and maximum aneurysm diameter. All devices were successfully deployed, with no type I or III endoleaks observed at procedure completion. The contrast volume was significantly greater in the p-branch group (100.8 mL vs 77.0 mL; P = .012). No significant difference was observed between the groups for the remaining intraoperative data. No major cardiac adverse events, paraplegia, or ischemic colitis have been observed during the first 30 days after the surgical procedures. Early outcomes were similar in both groups, with exception of intensive care unit stay duration, which was significantly greater for the p-branch (P = .001). Considering long-term complications, no significant difference was found between the groups with respect to the presence of types I or III endoleaks. From a total of 296 target vessels stented in the CMD group (mean of 3.36 per patient) and 42 in the p-Branch group (mean of 3.0 per patient), 5.06% and 7.14% presented instability, respectively, with no difference observed between the groups (P = .71). Secondary interventions were required in 36.4% of the CMD cases and 50% of the p-branch group, but this was not statistically different (P = .382). Kaplan-Meier analysis (Figure) did not reveal significant difference in the 5-year survival between the two groups (log-rank; P = .713). Comparable perioperative outcomes were obtained when appropriately selected patients were treated with either the OTS p-branch or CMD for JRAA. The long-term survival and target vessel instability do not appear impacted by the presence of pivot fenestrations in comparison with other target vessels configurations.