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使用米诺斯支架移植物系统对肾下腹主动脉瘤进行择期血管内修复的早期结果

Early Results of Elective Endovascular Repair of Infrarenal Abdominal Aortic Aneurysms With the Minos Stent-Graft System.

作者信息

Pitoulias Georgios A, Pitoulias Apostolos G, Chatzelas Dimitrios A, Zampaka Theodosia, Loutradis Charalampos, Potouridis Anastasios, Tachtsi Maria D

机构信息

Division of Vascular Surgery, 2nd Department of Surgery, Faculty of Medicine, School of Health Sciences, Aristotle University of Thessaloniki, "G. Gennimatas" Hospital, Thessaloniki, Greece.

出版信息

J Endovasc Ther. 2025 Feb;32(1):225-232. doi: 10.1177/15266028231172379. Epub 2023 May 11.

Abstract

PURPOSE

A variety of last-generation endografts are currently available for standard endovascular repair (EVAR) of infrarenal abdominal aortic aneurysms (AAAs). The purpose of this study is to report the preliminary clinical outcomes of the Minos trimodular stent-graft system, which was recently introduced to the European market.

MATERIALS AND METHODS

Between February 2020 and 2022, we treated 41 consecutive AAA patients (mean age 72.2±8.5, 37 males) with elective standard EVAR using the Minos. The mean maximum diameter of AAAs was 54.7±6.6 mm, the mean proximal neck's (PN) diameter was 24.8±2.7 mm, while the relevant length and angulation were 16.0 mm and 21.7°, respectively. Overall, 22 (53.6%) patients presented with shorter and angulated PN, according to the stent-graft's instructions of use, and in 6 (14.6%) patients the PN angulation >60° was combined with concomitant iliac angulation >60°. Eleven (26.8%) EVARs were performed with concomitant enormous iliac artery narrowing and tortuosity. Finally, in 19 (46.3%) AAAs, the distal iliac landing zone was aneurysmatic and they were treated with the bell-bottom technique in 17 patients and with limb extension to the external iliac artery in two cases. We evaluated technical and clinical success of the index procedures, which was based on the combination of five factors: freedom from EVAR-related mortality, from graft-related endoleak of any type, from migration at any part of graft as well the absence of notable increase AAA's sac maximum diameter and the patency of bifurcated stent-graft and of access vessels.

RESULTS

Primary technical and clinical success of index procedures was 100%. During a median 12-month radiological follow-up the clinical success remained 100%. No type I or III endoleak, stent-graft migration, EVAR-related death, AAA rupture, or graft-related adverse events or reinterventions were documented. Four (9.8%) type II endoleaks were detected with stable AAA sac diameter. The overall incidence of sac regression was 34.1% (n=14).

CONCLUSION

The preliminary results of our series showed that Minos provided excellent feasibility and safety features even through angulated and tortuous iliac vessels and in short and angulated PNs. The overall clinical success at 1 year suggests that performance of Minos follows very high standards. Further validation of these promising results with long-term data is acquired to complete the evaluation of this recently introduced stent-graft system.

CLINICAL IMPACT

The current study explored the clinical performance of a new in market ultra-low profile bifurcated abdominal aortic stent-graft, the MINOS. The early and 12-month results of study suggest that implantation of this stent-graft in standard EVAR, even in hostile proximal aortic neck and iliac vessels conditions, follows very high clinical standards and encourage the further clinical use of MINOS.

摘要

目的

目前有多种新一代腔内移植物可用于肾下腹主动脉瘤(AAA)的标准血管腔内修复术(EVAR)。本研究旨在报告最近引入欧洲市场的Minos三模块支架移植物系统的初步临床结果。

材料与方法

2020年2月至2022年期间,我们连续治疗了41例AAA患者(平均年龄72.2±8.5岁,男性37例),采用Minos进行择期标准EVAR。AAA的平均最大直径为54.7±6.6mm,近端颈部(PN)的平均直径为24.8±2.7mm,而相关长度和角度分别为16.0mm和21.7°。总体而言,根据支架移植物的使用说明,22例(53.6%)患者的PN较短且有角度,6例(14.6%)患者的PN角度>60°并伴有髂动脉角度>60°。11例(26.8%)EVAR手术伴有巨大的髂动脉狭窄和迂曲。最后,在19例(46.3%)AAA中,远端髂动脉着陆区为动脉瘤性,17例患者采用喇叭口技术治疗,2例患者采用肢体延伸至髂外动脉治疗。我们评估了索引手术的技术和临床成功率,其基于五个因素的组合:无EVAR相关死亡率、无任何类型的移植物相关内漏、移植物任何部位无移位、AAA瘤体最大直径无显著增加以及分叉支架移植物和入路血管通畅。

结果

索引手术的主要技术和临床成功率为100%。在中位12个月的影像学随访期间,临床成功率仍为100%。未记录到I型或III型内漏、支架移植物移位、EVAR相关死亡、AAA破裂或移植物相关不良事件或再次干预。检测到4例(9.8%)II型内漏,AAA瘤体直径稳定。瘤体缩小的总体发生率为34.1%(n = 14)。

结论

我们系列的初步结果表明,即使通过成角和迂曲的髂血管以及短而有角度的PN,Minos也具有出色的可行性和安全性。1年时的总体临床成功率表明Minos的性能符合非常高的标准。需要长期数据对这些有前景的结果进行进一步验证,以完成对这种最近引入的支架移植物系统的评估。

临床影响

本研究探讨了一种新上市的超低轮廓分叉腹主动脉支架移植物MINOS的临床性能。研究的早期和12个月结果表明,即使在近端主动脉颈部和髂血管条件不利的情况下,将这种支架移植物植入标准EVAR中也符合非常高的临床标准,并鼓励进一步临床使用MINOS。

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