Early Multicentre Outcomes of Endovascular Aortic Arch Repair Using a Custom-Made Triple-Branch NEXUS TRE Endograft System (TRE-ASURE Study).

IF 1.8 2区 医学 Q3 PERIPHERAL VASCULAR DISEASE
Prakash Saha, Michele Antonello, Theodosios Bisdas, Semih Buz, Ignacio Michel, Marina Ansuategui, Rafael García-Borbolla Fernández, Angel Flores Herrero, Gino Gemayel, Giacomo Isernia, Adrien Kaladji, Alexander Oberhuber, Gianbattista Parlani, Timothy A Resch, Gioele Simonte, Jean-Paul P M de Vries, Said Abisi
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引用次数: 0

Abstract

Objective: To report the first multicentre European experience with the custom-made NEXUS TRE triple-branch endograft for fully endovascular, debranch-free repair of complex aortic arch pathology, focusing on technical feasibility and early safety outcomes.

Methods: This retrospective multicentre analysis included 21 consecutive patients treated with the NEXUS TRE system across 13 European centres between August 2024 and October 2025. Baseline characteristics, procedural metrics, and early (≤30-day) outcomes were assessed. The primary endpoint was device technical success. Secondary endpoints included 30-day mortality, neurological events, spinal cord ischaemia, device-related reintervention, branch patency, and endoleaks.

Results: The median age was 75 years (range 59-86), and 19 patients (90.5%) were male. Indications included degenerative aortic arch aneurysm in 11 patients (52.4%) and aneurysmal degeneration following chronic dissection in 10 (47.6%). Primary technical success of the NEXUS TRE device was achieved in 20/21 patients (95.2%), with assisted technical success in 21/21 (100%). There was no in-hospital or 30-day mortality, and no disabling stroke or spinal cord ischaemia occurred. Two patients (9.5%) had nondisabling ischaemic strokes, both with diffusion-weighted-MRI-confirmed embolic infarction; a third patient developed a transient left vocal-cord palsy on a background of established infarcts, without new acute infarction on MRI. All symptoms resolved without disabling deficit (30-day modified Rankin Scale <2). Median procedure time was 227 minutes (IQR 200-278), fluoroscopy time 68.3 minutes (IQR 55.5-87.0), and contrast volume 145 mL (IQR 100-160). One type Ic endoleak that was identified on completion angiography (at the left subclavian bridging stent) was treated intra-operatively with no residual leak. Two type II endoleaks were managed conservatively, with no type Ia, type Ib, or persistent type III endoleak noted on postoperative CT angiography, with all supra-aortic target vessels remaining patent.

Conclusions: In this first multicentre European experience, the custom-made NEXUS TRE triple-branch system demonstrated high device technical success and an encouraging early (30-day) safety profile in selected high-risk patients. These findings support the feasibility of fully endovascular, debranch-free multi-branch repair of the aortic arch. Larger studies with longer follow-up are now required to assess durability.Clinical ImpactThis first multicentre European experience suggests that fully endovascular, debranch-free aortic arch repair using the custom-made NEXUS TRE triple-branch system is technically feasible in selected high-risk patients unsuitable for open repair. In 21 patients treated across 13 European centres, primary device technical success was 95.2%, assisted technical success was 100%, and no 30-day mortality, disabling stroke, spinal cord ischaemia, or target vessel occlusion occurred. These preliminary findings support further evaluation of triple-branch endografting as a less invasive strategy for complex aortic arch pathology.

使用定制的三分支NEXUS TRE血管内移植系统修复主动脉弓的早期多中心结果(TRE- ure研究)。
目的:报告欧洲首个多中心使用定制的NEXUS TRE三支内移植物进行血管内无脱支修复复杂主动脉弓病理的经验,重点关注技术可行性和早期安全性结果。方法:这项回顾性多中心分析纳入了2024年8月至2025年10月期间在13个欧洲中心连续接受NEXUS TRE系统治疗的21例患者。评估基线特征、程序指标和早期(≤30天)结果。主要终点是设备技术成功。次要终点包括30天死亡率、神经事件、脊髓缺血、器械相关的再干预、分支通畅和内漏。结果:中位年龄75岁(59 ~ 86岁),男性19例(90.5%)。适应症包括退行性主动脉弓动脉瘤11例(52.4%),慢性夹层后动脉瘤变性10例(47.6%)。20/21例患者(95.2%)获得了NEXUS TRE装置的初步技术成功,21/21例患者(100%)获得了辅助技术成功。没有住院或30天死亡,没有发生致残性中风或脊髓缺血。2例患者(9.5%)发生非致残性缺血性卒中,均伴有弥散加权mri证实的栓塞性梗死;第三例患者在确定的梗死背景下出现一过性左声带麻痹,MRI未发现新的急性梗死。结论:在第一个多中心的欧洲经验中,定制的NEXUS TRE三分支系统在选定的高风险患者中显示出很高的设备技术成功和令人鼓舞的早期(30天)安全性。这些发现支持了血管内、无分支脱脱的多分支修复主动脉弓的可行性。现在需要更大的研究和更长的随访时间来评估持久性。临床影响欧洲首个多中心的研究表明,对于不适合开放修复的高危患者,使用定制的NEXUS TRE三分支系统进行完全血管内无分支修复在技术上是可行的。在13个欧洲中心接受治疗的21例患者中,主要装置技术成功率为95.2%,辅助技术成功率为100%,未发生30天死亡率、致残性卒中、脊髓缺血或靶血管闭塞。这些初步发现支持进一步评估三分支内移植术作为一种微创治疗复杂主动脉弓病理的策略。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
5.30
自引率
15.40%
发文量
203
审稿时长
6-12 weeks
期刊介绍: The Journal of Endovascular Therapy (formerly the Journal of Endovascular Surgery) was established in 1994 as a forum for all physicians, scientists, and allied healthcare professionals who are engaged or interested in peripheral endovascular techniques and technology. An official publication of the International Society of Endovascular Specialists (ISEVS), the Journal of Endovascular Therapy publishes peer-reviewed articles of interest to clinicians and researchers in the field of peripheral endovascular interventions.
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