Early Experience With the Nexus Aortic Arch Endograft for Endovascular Treatment of Complex Aortic Arch Pathologies Beyond Standard Indications.

Background: The Nexus stent graft offers a minimally-invasive option for treating aortic arch aneurysms (AArA). Despite strict instructions for use (IFU), it is sometimes applied in complex anatomies for patients who are surgically inoperable or unsuitable for other devices. This study evaluates outcomes in patients treated outside the IFU, providing real-world insights.

Methods: We analyzed patients treated with the Nexus endograft outside its IFU between January 2022 and August 2024. The primary endpoint was the occurrence of major adverse cardiovascular and cerebral events (MACCE) such as death, stroke, or myocardial infarction. Secondary endpoints included the reasons for outside-IFU implantation, technical success, any aortic-related adverse events and postoperative endoleaks.

Results: Thirteen patients underwent endovascular treatment for AArA outside IFU. Five (38.5%) had a post-type A dissection, 5 had de novo AArA (38.5%), and 3 (23%) lacked a landing zone in zones 1 to 3 of the aortic arch for thoracoabdominal aortic repair. Seven patients (54%) received the Nexus One device, while 6 (46%) received the Nexus Duo endograft. No perioperative MACCE occurred. Mean follow-up was 17 ± 12 months, with a 79% survival rate at 1 year. Primary reasons for outside IFU use included an inner ascending length <30 mm and a descending aortic diameter >40 mm in 46% of patients accordingly. Technical success was achieved in all cases. A type Ic endoleak (7%) due to aneurysmatic degeneration of the brachiocephalic artery was identified at 2 years. No further aortic-related adverse events were reported.

Conclusions: The Nexus endograft demonstrated a favorable safety profile and promising clinical outcomes at 1 year, even in patients treated outside IFU criteria, with high technical success and no evidence of stroke. Reassessment of certain IFU criteria could enhance the device's applicability.

Clinical impact: Our findings highlight the potential for expanding the clinical use of the Nexus stent-graft beyond its current IFU, offering a safe and effective alternative for complex aortic arch anatomies. With high technical success and no perioperative cerebrovascular events, these results suggest that carefully selected patients who are otherwise ineligible for surgery may still benefit from endovascular repair. This study provides real-world evidence supporting the reconsideration of IFU criteria, potentially broadening treatment options. The innovation lies in demonstrating that even outside IFU conditions, the Nexus endograft maintains a strong safety profile, paving the way for more inclusive patient selection.