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.

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.