ArticleJTCVS structural and endovascular2026
Endovascular arch repair using a novel single branch arch stent graft: 30-Day results from the chronic dissection arm of the NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness investigational device exemption study.
Article in JTCVS structural and endovascular, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Objective: Moderate levels of frailty or a previous sternotomy make open repair of aortic arch pathology high risk or even preclude any treatment. This study examined 30-day outcomes from the NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness investigational device exemption (TRIOMPHE IDE) study of an off-the-shelf stent-graft system for Zone 0 endovascular aortic arch repair in patients with high-risk chronic dissection. Methods: TRIOMPHE IDE is a prospective, multicenter study evaluating the NEXUS system (Endospan) in chronic aortic dissection (n = 54). Following cervical debranching, NEXUS was delivered into the arch first, followed by an ascending aortic stent-graft. Results: All subjects were deemed high-risk for open repair (American Society of Anesthesiologists class IV 51.9% or class III 48.1%; mean European System for Cardiac Operative Risk Evaluation II score 10.3%). Comorbidities included chronic obstructive pulmonary disease (18.5%), coronary disease (42.6%), previous stroke (25.9%), and 70% with previous sternotomy. Successful deployment occurred in 100% of cases, with device technical success in 98.2% (53 out of 54) as 1 retrograde type A dissection required open repair. Thirty-day mortality was 9.3% (5 out of 54). One disabling stroke occurred after bypass (1.9%). There was 1 disabling thromboembolic stroke and 1 intracranial hemorrhage (3.7%) after the index procedure. There were no aortic ruptures, spinal cord ischemia, or permanent dialysis. On core-lab adjudicated 30-day computed tomography angiography, there were no Type 1a/1b or III endoleaks and 100% device patency. Median intensive care unit and hospital stays were 3.0 days (range, 1.0-13.0 days) and 7.0 days (range, 1.0-40.0 days). Conclusions: The 30-day results from the TRIOMPHE IDE study primary statistical cohort support the hypothesis that high-risk aortic arch dissection patients can be successfully treated using an off-the-shelf branched stent graft system, obviating the need for sternotomy or hypothermic arrest with open repair.
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