Clinical outcomes of thoracic endovascular aneurysm repair using commercially available fenestrated stent graft (Najuta endograft)

Objective Thoracic endovascular aneurysm repair (TEVAR) for the aortic arch aneurysm is challenging because of its curved anatomic configuration and the presence of the supra-aortic branches. The Najuta fenestrated endograft (Kawasumi Laboratories, Inc, Tokyo, Japan) was developed to treat aortic arch diseases, offering maximal proximal landing length while preserving the blood flow to the supra-aortic branches. We evaluated the perioperative and midterm outcomes of this fenestrated endograft. Methods Between July 2007 and July 2013, 32 patients were treated with the Najuta endograft at three vascular centers. The mean age of the patients was 74.5 ± 9.8 years (23 patients were men). Technical success, complication, overall survival rate, freedom from aneurysm-related death, secondary intervention, aneurysm enlargement, device migration, and patency of supra-aortic branches were investigated retrospectively. Results The median follow-up period was 2.5 years (range, 0.2-6.2 years). Seventy-one supra-aortic vessels (30 brachiocephalic arteries, 31 left common carotid arteries, 10 left subclavian arteries) were planned to be preserved with fenestrations. Technical success rate was 91% (29 of 32; three type I endoleaks were seen), and five perioperative complications (two Stanford A dissections, one cerebral infarction, one celiac artery obstruction, one spinal cord ischemia) were recognized. Perioperative death was not observed. Overall survival rate and rate of freedom from aneurysm-related death at 3 years were 67% and 97%, respectively. The rate of freedom from secondary intervention and the rate of freedom from aneurysm enlargement at 3 years were 84% and 85%, respectively. Device migration was not observed. There were two branch (left carotid artery and left subclavian artery) occlusions at 2 weeks after TEVAR due to the endograft's infolding. No other branch occlusion was seen in this follow-up period. As a result, the patency rate of the supra-aortic branch was 97% at 3 years. Conclusions The perioperative and 3-year outcomes of TEVAR using the Najuta precurved, fenestrated endograft demonstrated high freedom from aneurysm enlargement and patency rates of the supra-aortic branches.