Introduction: Endovascular treatment of juxtarenal aortic aneurysms is now widely accepted as a safe and effective alternative to open repair. Bridging stent-grafts (BSGs) are used to provide continuity between the main aortic graft and renovisceral target vessels (TVs) in fenestrated endovascular aneurysm repair (FEVAR). The BeFlared (Bentley InnoMed GmbH, Hechingen, Germany) represents the first dedicated BSG specifically designed for FEVAR, incorporating a novel flaring system that enables precise positioning and sealing in a single step. This study aims to evaluate the impact of BeFlared on procedural efficiency, radiation exposure, and deployment accuracy. Methods: A prospective registry of patients who underwent elective FEVAR at 3 Italian centers during February and March 2025 was retrospectively reviewed. Procedural parameters, including mean operative time, mean bridging time, and fluoroscopy duration, were recorded. Technical success was defined as successful stent deployment in all intended TVs. Cone-beam computed tomography (CBCT) was performed intraoperatively, and follow-up computed tomography angiography (CTA) was conducted 1 month post-procedure to assess geometric outcomes and complications. These parameters were compared with corresponding measurements obtained from a control cohort of patients who underwent FEVAR procedures, between 2020 and 2024 in the same 3 Italian centers, utilizing the Bentley BeGraft as BSG. Results: Eight FEVAR procedures were performed, with a total of 31 TVs treated using BeFlared stents. The control cohort comprised 60 FEVAR procedures performed using the Bentley BeGraft as the BSG, involving a total of 185 renovisceral TVs. The BeFlared group demonstrated significantly improved intraoperative outcomes compared with the control group. Median operative time was 241 (interquartile range [IQR]=185-295) minutes vs 270.3 (IQR=207-365) minutes (p=0.022), mean bridging stent deployment time was 5 (IQR=4.25-6.15) minutes vs 7.6 (IQR=4.8-9.7) minutes (p<0.001), and median fluoroscopy time was 72.2 (IQR=51-81) minutes vs 82.7 (IQR=49.5-113) minutes (p=0.064). Only 1 patient in the BeFlared cohort required brief intensive care unit admission. The average hospital stay was 5.1 (IQR=4-6) days compared with 5.7 (3-10) days in the control group (p=0.882). In the BeFlared cohort, technical success was achieved in 96.7% of TVs (30/31), no perioperative deaths or TV-related complications were observed. Geometric analysis showed that BeFlared stents had more uniform deployment, with lower variability regarding the landing zone of the BSG in the TV (16.4 mm, IQR=16-17.1 vs 15.4 mm, IQR=14.2-16.6; p<0.001) and BSG aortic protrusion (4.2 mm, IQR=4.1-4.4 vs 5.1 mm, IQR=4.2-5.7; p<0.001) compared with BeGraft. BeFlared also demonstrated a significantly larger proximal stent diameter (10.6 mm, IQR=10.4-11.4 vs 99.5 mm, IQR=8.7-10.2; p<0.001), greater mean flaring angle (51.9 mm, IQR=47.4-55.8 vs 41.4 mm, IQR=37-48.3; p<0.001), and reduced inferior flaring angle (67.8 mm, IQR=61.5-72.4 vs 75.1 mm, IQR=67.4-82; p<0.001). Conclusions: BeFlared demonstrated favorable short-term outcomes, with notable reductions in operative time, radiation exposure, and device manipulation. The geometric consistency and standardized deployment process offer encouraging early evidence of the system's clinical utility. Further studies are required in order to assess long-term safety and cost-effectiveness, as well as durability, across a wider patient population.Clinical ImpactThe BeFlared bridging stent introduces an innovative one-step flaring system that simplifies target vessel stenting during fenestrated endovascular aortic repair (FEVAR). This device enables more precise and reproducible deployment, reducing operative and fluoroscopy times while minimizing radiation exposure. For clinicians, these improvements translate into a safer, more standardized procedure with fewer technical maneuvers and potentially lower complication risks. The enhanced geometric consistency observed with BeFlared may improve long-term branch stability and durability, supporting its role as a next-generation device for complex aortic repair and a valuable advancement in endovascular practice.
Geometrical Analysis and Initial Experience With Bentley's BeFlared Bridging Stent for Fenestrated Endovascular Aneurysm Repair
Veraldi, Gian Franco;
2025-01-01
Abstract
Introduction: Endovascular treatment of juxtarenal aortic aneurysms is now widely accepted as a safe and effective alternative to open repair. Bridging stent-grafts (BSGs) are used to provide continuity between the main aortic graft and renovisceral target vessels (TVs) in fenestrated endovascular aneurysm repair (FEVAR). The BeFlared (Bentley InnoMed GmbH, Hechingen, Germany) represents the first dedicated BSG specifically designed for FEVAR, incorporating a novel flaring system that enables precise positioning and sealing in a single step. This study aims to evaluate the impact of BeFlared on procedural efficiency, radiation exposure, and deployment accuracy. Methods: A prospective registry of patients who underwent elective FEVAR at 3 Italian centers during February and March 2025 was retrospectively reviewed. Procedural parameters, including mean operative time, mean bridging time, and fluoroscopy duration, were recorded. Technical success was defined as successful stent deployment in all intended TVs. Cone-beam computed tomography (CBCT) was performed intraoperatively, and follow-up computed tomography angiography (CTA) was conducted 1 month post-procedure to assess geometric outcomes and complications. These parameters were compared with corresponding measurements obtained from a control cohort of patients who underwent FEVAR procedures, between 2020 and 2024 in the same 3 Italian centers, utilizing the Bentley BeGraft as BSG. Results: Eight FEVAR procedures were performed, with a total of 31 TVs treated using BeFlared stents. The control cohort comprised 60 FEVAR procedures performed using the Bentley BeGraft as the BSG, involving a total of 185 renovisceral TVs. The BeFlared group demonstrated significantly improved intraoperative outcomes compared with the control group. Median operative time was 241 (interquartile range [IQR]=185-295) minutes vs 270.3 (IQR=207-365) minutes (p=0.022), mean bridging stent deployment time was 5 (IQR=4.25-6.15) minutes vs 7.6 (IQR=4.8-9.7) minutes (p<0.001), and median fluoroscopy time was 72.2 (IQR=51-81) minutes vs 82.7 (IQR=49.5-113) minutes (p=0.064). Only 1 patient in the BeFlared cohort required brief intensive care unit admission. The average hospital stay was 5.1 (IQR=4-6) days compared with 5.7 (3-10) days in the control group (p=0.882). In the BeFlared cohort, technical success was achieved in 96.7% of TVs (30/31), no perioperative deaths or TV-related complications were observed. Geometric analysis showed that BeFlared stents had more uniform deployment, with lower variability regarding the landing zone of the BSG in the TV (16.4 mm, IQR=16-17.1 vs 15.4 mm, IQR=14.2-16.6; p<0.001) and BSG aortic protrusion (4.2 mm, IQR=4.1-4.4 vs 5.1 mm, IQR=4.2-5.7; p<0.001) compared with BeGraft. BeFlared also demonstrated a significantly larger proximal stent diameter (10.6 mm, IQR=10.4-11.4 vs 99.5 mm, IQR=8.7-10.2; p<0.001), greater mean flaring angle (51.9 mm, IQR=47.4-55.8 vs 41.4 mm, IQR=37-48.3; p<0.001), and reduced inferior flaring angle (67.8 mm, IQR=61.5-72.4 vs 75.1 mm, IQR=67.4-82; p<0.001). Conclusions: BeFlared demonstrated favorable short-term outcomes, with notable reductions in operative time, radiation exposure, and device manipulation. The geometric consistency and standardized deployment process offer encouraging early evidence of the system's clinical utility. Further studies are required in order to assess long-term safety and cost-effectiveness, as well as durability, across a wider patient population.Clinical ImpactThe BeFlared bridging stent introduces an innovative one-step flaring system that simplifies target vessel stenting during fenestrated endovascular aortic repair (FEVAR). This device enables more precise and reproducible deployment, reducing operative and fluoroscopy times while minimizing radiation exposure. For clinicians, these improvements translate into a safer, more standardized procedure with fewer technical maneuvers and potentially lower complication risks. The enhanced geometric consistency observed with BeFlared may improve long-term branch stability and durability, supporting its role as a next-generation device for complex aortic repair and a valuable advancement in endovascular practice.
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