Short-term outcomes of endovascular aortic aneurysm repair with the new Braile Biomédica® total custom-made abdominal endograft: Experience from three Italian centers

Abstract

Introduction: Since 2019, Braile Biomédica® introduced a novel custom-made abdominal endograft tailored to the aorta's anatomy, featuring sizing every 3 mm and a diameter change from 50 mm to 8 mm. This design permits uncovered fenestrations around a single Z stent, eliminating the need for bridging stents to visceral vessels. Utilizing triple stent technology, optimal neck fixation is ensured, enabling treatment of necks shorter than 2 mm, with three 360° fenestrations optimizing graft fixation. This paper aims to analyze the initial experience with this custom-made infrarenal graft for abdominal aorta aneurysm (AAA), concerning procedural success and post-procedural short-term outcomes.

Results: Among 12 patients treated from May 2022 to January 2024, technical success was achieved in 91.7 %, with only one intra-procedural complication. Follow-up CT scans at 1-3 months revealed resolution of an intraoperative endoleak and two late complications: a late type III endoleak and right renal artery occlusion.

Conclusions: The recent experience with Braile Biomédica® custom-made abdominal endograft demonstrates promising outcomes, particularly in treating AAAs with challenging anatomical features.

Keywords: Abdominal aorta aneurysm; Custom-made devices; Endovascular aortic aneurysm repair.