This study aims to present the medium-term outcomes of Extra-Design engineering endografts with inner branches (EDE-iBEVARs, Artivion) in endovascular aortic repairs of complex aneurysms building upon promising early results. A retrospective, international, multi-center study was conducted including consecutive patients who underwent complex endovascular aortic repairs using EDE-iBEVARs between 2018 and 2022. Patient demographics, aneurysm anatomical features, procedural details, reinterventions, complications, and endograft failures during follow-up were assessed. The primary outcome was aneurysm-related mortality. Secondary outcome measures included the freedom from all-cause mortality and reintervention, technical and clinical success, and late related complications including branch instability, endoleaks, and serious adverse events. Our study encompassed a total of 260 patients across 13 European centers. The cohort included patients with thoracoabdominal aortic aneurysms (n = 116), suprarenal or juxta-renal aneurysms (n = 95), and those who had previous open repair or previous endovascular aortic repair with type 1A endoleak (n = 49). Of 982 possible inner branches (937 antegrade and 45 retrograde), 962 (98%) were successfully cannulated and bridged with covered stents during the index procedure. Overall, the endograft was successfully deployed in 98% of patients, and 93% were discharged from hospital following surgery. At 3 years, freedom from aneurysm-related mortality was 97%, whereas the freedom of all-cause mortality was 89%. Freedom from reinterventions was 91% and 76% at 1 and 3 years, respectively. The rate of late complications such as endoleaks or branch instability events was 12% (n = 30). The late branch occlusion rate during follow-up was 1.5% (n = 15), of which 12 were renal branches. EDE-iBEVARs demonstrate satisfactory medium-term outcomes with reintervention rates comparable to other endografts. Encouragingly, rates of branch patency were high, and major adverse events were low. This technology could expand the treatment options for patients with challenging complex aortic conditions.

中文翻译：

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EXTENT 研究：多中心合作的 EXTra 设计工程内分支 ENdografts 用于治疗复杂主动脉瘤的中期结果

本研究旨在基于有希望的早期结果，展示具有内分支的 Extra-Design 工程内移植物（EDE-iBEVARs、Artivion）在复杂动脉瘤血管内修复中的中期结果。开展了一项回顾性、国际性、多中心研究，纳入了 2018 年至 2022 年间使用 EDE-iBEVAR 进行复杂的主动脉腔内修复术的连续患者。随访期间的患者人口统计、动脉瘤解剖特征、手术细节、再次干预、并发症和内移植物失败进行了评估。主要结局是动脉瘤相关死亡率。次要结局指标包括无全因死亡率和再次干预、技术和临床成功以及晚期相关并发症，包括分支不稳定、内漏和严重不良事件。我们的研究涵盖了 13 个欧洲中心的总共 260 名患者。该队列包括胸腹主动脉瘤患者 (n = 116)、肾上或肾旁动脉瘤患者 (n = 95)，以及既往接受过开放修复或既往 1A 型内漏血管内主动脉修复术的患者 (n = 49)。在 982 个可能的内部分支（937 个顺行和 45 个逆行）中，962 个（98%）在索引过程中成功插管并用覆膜支架桥接。总体而言，98% 的患者成功植入内移植物，93% 的患者术后出院。 3 年时，无动脉瘤相关死亡率为 97%，而无全因死亡率为 89%。 1 年和 3 年免于再次干预的比例分别为 91% 和 76%。内漏或分支不稳定事件等晚期并发症的发生率为 12% (n = 30)。随访期间晚期分支闭塞率为1.5%（n=15），其中肾支12个。 EDE-iBEVARs 表现出令人满意的中期结果，其再干预率与其他内移植物相当。令人鼓舞的是，分支通畅率很高，主要不良事件也很低。这项技术可以为患有复杂主动脉疾病的患者提供更多的治疗选择。