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

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 Impact This 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.