Impact of a new stepped balloon for bridging stent implantation on procedural time and radiation exposure in fenestrated endovascular aortic repair.

Abstract

To evaluate the impact of a new dedicated stepped balloon-mounted bridging stent (BS) on procedural time, radiation exposure, and early technical outcomes in patients undergoing fenestrated endovascular aortic repair (FEVAR). A retrospective study was conducted on patients treated with four-fenestration FEVAR at a high-volume aortic center between March 2020 and March 2025. Patients were categorized into three groups: standard balloon BS (BeGraft, BG, Bentley) and renal access with preloaded renal catheters, BG and renal access with steerable sheaths, and stepped balloon BS (BeFlared, Bentley) and renal access with steerable sheaths. All procedures were recorded. Primary end points included stenting time and radiation exposure (dose, dose area product, fluoroscopy time) for all four target vessels (TVs), and specifically for each TV. Secondary end points included intraoperative complications, flaring characteristics, and 30-day outcomes. Postoperative computed tomography imaging-assessed BS positioning, sealing, and flaring diameters. In total, 60 patients with 240 TVs were included. The stepped balloon stepped balloon BS group (n = 20) showed significantly shorter median total stenting time (11.3 minutes; interquartile range [IQR], 10.9-12 minutes) compared with both standard balloon BG groups (n = 20 in each group) (17.4 minutes and 20.2 minutes; P < .001). Total stenting DAP was also significantly lower with the stepped balloon (4.6 Gy cm² vs 9.3 and 11.4 Gy cm²; P = .001). Fluoroscopy time was reduced in all TVs (P < .001). Flaring diameters were larger in the stepped balloon group across all TV (celiac trunk P = .002; superior mesenteric artery P = .002; right renal artery P ≤ .001; and left renal artery P = .126). Technical success was 100% in all groups, with no significant difference in complication rates. One-month computed tomography scans showed patency of all TV; one BS (1/236 [0.4%]) early reintervention was performed for a celiac trunk stent fracture, with an arcuate ligament found on the preoperative computed tomography scan. The use of BSs with stepped balloons and steerable sheaths in FEVAR significantly reduced stenting time and radiation exposure while preserving procedural safety and improving flaring characteristics. These findings suggest procedural streamlining and potential clinical advantages of this new generation BS during complex aortic repair. Further prospective, multicenter studies are warranted to confirm these favorable early outcomes.