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基于 E-xtra 设计平台的全国多中心登记研究:腔内分支型主动脉覆膜支架治疗的结果。

Inner branched complex aortic repair outcomes from a national multicenter registry using the E-xtra design platform.

机构信息

Unit of Vascular and Endovascular Surgery, Santa Maria della Misericordia Hospital, Perugia, Italy.

Unit of Vascular and Endovascular Surgery, Santa Maria della Misericordia Hospital, Perugia, Italy.

出版信息

J Vasc Surg. 2023 Feb;77(2):338-346. doi: 10.1016/j.jvs.2022.08.034. Epub 2022 Sep 5.

Abstract

BACKGROUND

Complex aortic pathology still represents an open issue in contemporary endovascular management, with continuous technological advancement being introduced in practice over time aiming to improve outcomes. Thus far, the dualism between the fenestrated and branched configuration for visceral artery revascularization is yet unsolved, with each approach having its own pros and cons. The inner branched technology for endovascular aneurysm repair (iBEVAR) aims to take the best out of both strategies, offering wide applicability and stable bridging stent sealing. The objective of this study was to evaluate the early outcomes obtained with a single manufacturer custom-made inner-branched endograft in a multicenter Italian experience.

METHODS

All patients consecutively treated with E-xtra design devices in three Italian facilities were enrolled. Anatomic characteristics and perioperative data were analyzed. The main objective was to asses technical and clinical success after iBEVAR. Secondary end points were overall survival, aortic-related mortality, target visceral vessel (TVV) patency, and freedom from target vessel instability during follow-up.

RESULTS

From 2016 to 2021, 45 patients were treated with an E-xtra design device revascularizing at least one visceral vessel through an inner branch. The mean age at the time of the procedure was 71.1 ± 9.3 years and 77.8% were males. The total number of target visceral arteries to be bridged with an inner branch was 159. The extent of aortic repair was thoracoabdominal in 91.1% of the cases. Technical success was achieved in 93.3% of the procedures (42/45) with all failures owing to a type I endoleak at final angiography. Each TVV was successfully connected to the graft's main body as planned without complications. Following their intervention, five patients developed spinal cord ischemia and in three of these cases symptoms persisted after discharge (6.7%). At 30 days clinical success was 93.3% (42/45). No death as well as no TVV thrombosis occurred within 30 days from the primary procedures. The mean follow-up was 22.8 ± 14.2 months. The Kaplan-Meier estimate of overall survival and TVV patency at 36 months were 83.9% and 95.9%, respectively.

CONCLUSIONS

Inner branches seem to be a promising technology in the complex aortic repair landscape, with an applicability ranging from type II thoracoabdominal aneurysm to type I endoleak repair after infrarenal endografting. Whether iBEVAR could offer results comparable with those provided by fenestrated/branched endovascular aneurysm repair in terms of target vessel patency and stent stability is yet to be established and further studies are, therefore, needed.

摘要

背景

复杂的主动脉病理学在当代血管内管理中仍然是一个悬而未决的问题,随着时间的推移,不断引入的技术进步旨在改善治疗效果。迄今为止,内脏动脉血运重建的分支型和开窗型之间的二分法仍然没有得到解决,每种方法都有其自身的优缺点。腔内分支技术(iBEVAR)旨在结合这两种策略的优势,提供广泛的适用性和稳定的分支支架密封。本研究的目的是评估在意大利的多中心经验中,使用单一制造商定制的腔内分支移植物获得的早期结果。

方法

连续纳入在意大利三家机构接受 E-xtra 设计装置治疗的所有患者。分析解剖特征和围手术期数据。主要目标是评估 iBEVAR 后的技术和临床成功率。次要终点是总体生存率、主动脉相关死亡率、靶内脏血管(TVV)通畅率以及随访期间靶血管不稳定的无进展率。

结果

2016 年至 2021 年,45 例患者接受了 E-xtra 设计装置治疗,通过腔内分支至少重建了一条内脏血管。手术时的平均年龄为 71.1±9.3 岁,77.8%为男性。需要通过腔内分支进行血运重建的靶内脏动脉总数为 159 条。主动脉修复的范围在 91.1%的病例中为胸腹主动脉。93.3%(42/45)的手术获得技术成功,所有失败均归因于最终血管造影时出现 I 型内漏。每一条 TVV 都按计划成功地与移植物的主体连接,没有出现并发症。干预后,5 例患者发生脊髓缺血,其中 3 例出院后仍存在症状(6.7%)。30 天时的临床成功率为 93.3%(42/45)。在原发性手术 30 天内无死亡和 TVV 血栓形成。平均随访时间为 22.8±14.2 个月。36 个月时的总体生存率和 TVV 通畅率的 Kaplan-Meier 估计值分别为 83.9%和 95.9%。

结论

腔内分支似乎是复杂主动脉修复领域的一种有前途的技术,其适用性范围从 II 型胸腹主动脉瘤到肾下覆膜支架植入后 I 型内漏修复。iBEVAR 在靶血管通畅率和支架稳定性方面是否能提供与开窗/分支腔内血管修复相当的结果,尚有待确定,因此需要进一步研究。

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