使用定制三分支NEXUS TRE内移植物系统进行血管内主动脉弓修复的早期多中心结局（TRE-ASURE研究）

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中文摘要

目的： 报告欧洲首个使用定制NEXUS TRE三分支内移植物进行完全血管内、免去分支修复复杂主动脉弓病变的多中心经验，重点关注技术可行性和早期安全性结局。
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。评估了基线特征、手术指标和早期（≤30天）结局。主要终点是器械技术成功。次要终点包括30天死亡率、神经系统事件、脊髓缺血、器械相关再干预、分支通畅性和内漏。
结果： 中位年龄为75岁（范围59-86），19例患者（90.5%）为男性。适应证包括11例（52.4%）退行性主动脉弓动脉瘤和10例（47.6%）慢性夹层后动脉瘤样退变。NEXUS TRE器械的初次技术成功在20/21例（95.2%）患者中实现，辅助技术成功在21/21例（100%）中实现。无院内或30天死亡，也未发生致残性卒中或脊髓缺血。2例患者（9.5%）发生非致残性缺血性卒中，两例均经弥散加权MRI证实为栓塞性梗死；第3例患者在既有梗死背景下出现短暂性左侧声带麻痹，MRI未见新的急性梗死。所有症状均缓解，无致残性缺损（30天改良Rankin量表<2）。中位手术时间为227分钟（IQR 200-278），透视时间为68.3分钟（IQR 55.5-87.0），造影剂用量为145 mL（IQR 100-160）。在完成血管造影时发现1例Ic型内漏（位于左锁骨下动脉桥接支架处），并在术中处理，无残余内漏。2例II型内漏采用保守治疗，术后CT血管造影未见Ia型、Ib型或持续性III型内漏，所有主动脉上目标血管均保持通畅。
结论： 在这首个欧洲多中心经验中，定制NEXUS TRE三分支系统在选定的高危患者中显示出较高的器械技术成功率和令人鼓舞的早期（30天）安全性特征。这些发现支持完全血管内、免去分支多分支修复主动脉弓的可行性。现在需要更大规模、更长随访的研究来评估耐久性。临床影响：这首个欧洲多中心经验表明，对于不适合开放修复的选定高危患者，使用定制NEXUS TRE三分支系统进行完全血管内、免去分支主动脉弓修复在技术上是可行的。在13个欧洲中心治疗的21例患者中，初次器械技术成功率为95.2%，辅助技术成功率为100%，且未发生30天死亡、致残性卒中、脊髓缺血或目标血管闭塞。这些初步发现支持进一步评估三分支内移植物作为复杂主动脉弓病变微创策略的价值。

英文摘要

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.