PURPOSE: To assess the feasibility and safety of the first commercially available off-the-shelf multibranched endograft for total endovascular repair of thoracoabdominal aortic aneurysms (TAAA). METHODS: Between November 2012 and May 2013, 15 patients (10 men; mean age 70 years) with TAAA underwent implantation of the Zenith t-Branch device, which received European marketing approval in late 2012. Three patients presented with symptomatic TAAAs, and 2 patients had a chronic Stanford type B dissection with false lumen expansion. In a retrospective review of the prospectively collected data, the primary endpoint was 30-day mortality from any cause; the primary outcome measure was technical success. Secondary endpoints were postoperative complications, including renal failure requiring dialysis, organ ischemia, and spinal cord ischemia. Radiological outcomes, such as any type of endoleak, further aneurysm expansion, and branch occlusion, were also assessed. RESULTS: Technical success was 100%, with all target vessels connected and patent. There was no renal function deterioration or organ ischemia. Paraplegia was observed in one patient despite cerebrospinal fluid drainage and monitoring. Four patients suffered from transient paraparesis, which was completely resolved before discharge. There was no in-hospital or 30-day mortality. After a mean follow-up of 5 months, no patient has died, and there has been no branch occlusion or type I/III endoleaks. CONCLUSION: Use of the off-the-shelf t-Branch device in the treatment of TAAAs is feasible and safe, with encouraging early clinical and radiological outcomes. Long-term results are necessary to evaluate the applicability and performance of this endograft in the urgent setting.
PURPOSE: To assess the feasibility and safety of the first commercially available off-the-shelf multibranched endograft for total endovascular repair of thoracoabdominal aortic aneurysms (TAAA). METHODS: Between November 2012 and May 2013, 15 patients (10 men; mean age 70 years) with TAAA underwent implantation of the Zenith t-Branch device, which received European marketing approval in late 2012. Three patients presented with symptomatic TAAAs, and 2 patients had a chronic Stanford type B dissection with false lumen expansion. In a retrospective review of the prospectively collected data, the primary endpoint was 30-day mortality from any cause; the primary outcome measure was technical success. Secondary endpoints were postoperative complications, including renal failure requiring dialysis, organ ischemia, and spinal cord ischemia. Radiological outcomes, such as any type of endoleak, further aneurysm expansion, and branch occlusion, were also assessed. RESULTS: Technical success was 100%, with all target vessels connected and patent. There was no renal function deterioration or organ ischemia. Paraplegia was observed in one patient despite cerebrospinal fluid drainage and monitoring. Four patients suffered from transient paraparesis, which was completely resolved before discharge. There was no in-hospital or 30-day mortality. After a mean follow-up of 5 months, no patient has died, and there has been no branch occlusion or type I/III endoleaks. CONCLUSION: Use of the off-the-shelf t-Branch device in the treatment of TAAAs is feasible and safe, with encouraging early clinical and radiological outcomes. Long-term results are necessary to evaluate the applicability and performance of this endograft in the urgent setting.