Background: Thoracic endovascular aortic repair (TEVAR) for thoracic aortic aneurysms (TAAs) is in rapid expansion due to its minimal invasiveness. However, TEVAR for an arch aneurysm with a straight stent graft needs surgical reconstruction for supra-aortic vessels. A branched stent graft pioneered by Inoue (branched Inoue Stent Graft [ISG]) has been expected to resolve this problem, but its utility remains to be established in the real clinical setting. This study evaluated the long-term clinical outcome of branched ISGs for TAAs.
Methods: Among 217 consecutive patients who underwent TEVAR with ISGs between March 2003 and September 2013, 89 patients with TAAs were treated with implantation of the branched ISG (single branch: n = 64; double branch: n = 18; triple branch: n = 7). The primary end point was freedom from aneurysm-related death. Secondary end points included peri-procedural adverse events, freedom from all-cause death and major adverse events (composite of aneurysm-related death, surgical conversion, aneurysm rapture, persistent type I or III endoleak, graft infection, graft occlusion, graft migration, and aneurysm expansion), changes of aneurysm diameter, stroke, and any endovascular reintervention during follow-up.
Results: All deployments of branched ISGs were successful. The 30-day mortality was 4.5% (single branch, 3.1%; double branch, 0%; triple branch, 29%), and periprocedural stroke was 16% (single branch, 7.8%; double branch, 33%; triple branch, 42%). At 1 and 5 years, freedom from aneurysm-related death was 93% and 93%, respectively, and freedom from all-cause death was 85% and 59%, respectively. Survival free of major adverse events was 76% at 5 years. The cumulative incidence of stroke was 11% at 5 years. Three patients underwent surgical conversion because of persistent type I endoleak. One branch graft occlusion was observed at the left subclavian artery in a patient who received a double-branched graft.
Conclusions: Periprocedural outcome of the single-branched ISG was acceptable, and long-term safety and efficacy were demonstrated. However, the procedural complications of the multibranched ISG leave room for improvement.