Preliminary results from an Italian National Registry on the outcomes of the Najuta fenestrated aortic arch endograft

Background: Arch pathology represents one of the last frontiers in aortic aneurysm endovascular management. Several companies recently developed dedicated branched and fenestrated endografts specifically designed for the aortic arch, aiming to overcome some of the issues associated with standard thoracic endograft and supra-aortic vessels extra-anatomic debranching. This study aimed to evaluate early outcomes obtained with a custom-made fenestrated endograft approved for thoracic aortic aneurysms exclusion.

Methods: All consecutive patients treated with the Najuta endograft (Kawasumi Laboratories, Inc, Tokyo, Japan) in Italy were enrolled prospectively and included in the study population. Anatomic characteristics and perioperative data were analyzed retrospectively. Study end points were technical success, 30-day clinical success, overall survival, supra-aortic vessel patency, endoleak, and need for reintervention or surgical conversion.

Results: Between 2018 and 2022, 76 patients received a Najuta endograft in Italy and were enrolled in the study. The median patient age was 72 years (interquartile range, 69-76 years) and 80.3% were male. Most of the patients received treatment for atherosclerotic aneurysms (80.3%); others were treated for postdissection aneurysms (7.9%), penetrating aortic ulcer (9.2%), or type I endoleak correction after previous thoracic endovascular repair (2.6%). Overall, 161 supra-aortic vessels were preserved through a dedicated fenestration. Technical success was achieved in 74 of 76 procedure (97.4%); both failures were associated with endoleak detection at final angiography (one type I and one type III endoleak). Two distal migrations occurred during the implanting procedure. Clinical success at 30 days was 94.7%. Two early reinterventions were needed within 30 days after index procedure: in one case, an aortic false lumen coils embolization was performed, because distal re-entry caused enlargement of the postdissection thoracic aneurysm. The other procedure consisted of a femoral pseudoaneurysm repair. The median follow-up was 7 months (interquartile range, 3-15 months); no supra-aortic vessel occlusions occurred and no patients needed surgical conversion.

Conclusions: Early results suggest that, in selected patients with aortic arch pathology needing a proximal landing, an endovascular approach with the Najuta system is safe and effective, especially for those at high surgical risk. A strict follow-up with high-quality computed tomography angiography images and eventual evaluation for long-term complications is needed to confirm these initial experience findings.