Arch pathology represents nowadays one of the last edges in the endovascular management of aortic aneurysms. Several companies developed in the last years dedicated custom-made branched and fenestrated endograft for the aortic arch, intended to overcome anatomical issues associated with standard thoracic endograft and supra-aortic vessels extra-anatomical debranching.
This study aimed to evaluate the feasibility and early outcomes obtained with a single model semi-custom-made fenestrated endograft approved for thoracic aortic aneurysms treatment
All consecutive patients treated with the Najuta endograft (Kawasumi Laboratories, Inc, Tokyo, Japan) in eighteen Italian vascular centers were prospectively enrolled. Anatomical characteristics and perioperative data were retrospectively analyzed. The primary endpoint was to assess technical success defined as effective endograft deployment with aneurysm exclusion at completion angiography. Secondary outcomes were cumulative survival, need for 30-days reintervention, perioperative complications and endoleaks.
During the period 2018-2022 sixty-five patients were enrolled. The median age was 72 (IQR 69-76) years and 73.8% were male. Most of the patients received treatment for atherosclerotic aneurysms (89.2%) while the others for post-dissection aneurysms (7.7%) or type I endoleak correction after previous thoracic endovascular repair. (3.1%). Overall, one hundred and sixteen supra-aortic vessels were preserved through a dedicated fenestration. Technical success was achieved in 97% of procedures. Both failures were associated with endoleak detection at final angiography (One type I and one type III endoleak). These patients underwent successful aneurysm exclusion at
2 and 6 months respectively with an additional thoracic endografting.
At 30 days only one perioperative death occurred, related to an acute respiratory failure in a patient affected by severe chronic obstructive pulmonary disease. Two cases of minor stroke were recorded during the perioperative period.
Two early reinterventions were needed within 30 days: in one case an aortic false lumen coils embolization was performed, since distal re-entry caused enlargement of the post dissection thoracic aneurysm. The other procedure consisted of a femoral pseudoaneurysm repair.
The median follow-up was 7 (IQR 3-15) months
No other reinterventions nor conversions were needed during the follow-up period.
These perioperative results suggest how, according to pathology complexity, an endovascular approach with the Najuta system results safe and effective, especially in patients deemed at high surgical risk. A strict follow-up with high-quality computed tomography angiography images and long-term evaluation of possible late complications is mandatory to confirm these initial experience findings.