Early single-centre experience with physician-modified and Najuta fenestrated endografts for aortic arch disease: technical considerations and bailout strategies.

Background: Thoracic endovascular aortic repair (TEVAR) for aortic arch disease involving the supra-aortic branches remains technically challenging because of the need to preserve branch perfusion while achieving an adequate proximal sealing zone. The Najuta stent graft is a semi-custom-made fenestrated device available in Japan, whereas physician-modified endograft TEVAR (PMEG-TEVAR) allows intraoperative device modification. This study aimed to evaluate our early experience with these two fenestrated TEVAR strategies and to describe their technical characteristics and pitfalls. Methods: We retrospectively reviewed 67 patients who underwent TEVAR at our institution between January 2024 and May 2026. Among these, 19 patients who underwent fenestrated TEVAR were included in this analysis. Baseline and anatomical characteristics, procedural details, technical success, endoleak, complications, and early outcomes were summarised descriptively for the PMEG-TEVAR and Najuta groups. Results: The distributions of underlying pathology and proximal landing zones differed between the groups. Aortic dissection accounted for 6/9 patients (66.7%) in the PMEG-TEVAR group and 1/10 (10.0%) in the Najuta group (P=0.04). Zone 0 landing was performed in 1/9 patients (11.1%) and 7/10 (70.0%), respectively, with an overall difference in landing-zone distribution (P=0.04). Primary technical failure occurred in one patient in each group. In the PMEG-TEVAR group, misalignment of the fenestration with the left common carotid artery required an additional one-debranching procedure, resulting in assisted technical success. In the Najuta group, severe thoracoabdominal aortic tortuosity prevented delivery of the device. During follow-up, another patient underwent additional TEVAR for aneurysm sac enlargement associated with a persistent endoleak. Endoleak was observed in one patient in the PMEG-TEVAR group and in two patients in the Najuta group. Perioperative outcomes were summarised descriptively for each group, as the small, indication-based cohorts did not permit a comparative assessment of equivalence. Conclusions: In this early single-centre experience, PMEG-TEVAR and Najuta provided distinct technical approaches for selected patients with aortic arch disease. PMEG-TEVAR offered procedural flexibility and immediate availability, whereas Najuta provided anatomy-based conformability and the potential for a longer proximal sealing zone. Careful anatomy- and pathology-based device selection and advance planning of bailout strategies are essential.