Initial clinical experience with a new low-profile thoracic endograft

Background The Zenith Alpha thoracic endograft (William Cook Europe, ApS, Bjaeverskov, Denmark) is a new low-profile thoracic endograft that has recently become commercially available in Europe. The reduced profile offers potential benefits and extended applicability, especially in patients with small or diseased iliofemoral vessels. The aim of this study was to evaluate the safety and efficacy of thoracic endovascular aortic repair performed with the new Zenith Alpha thoracic endograft. Methods From November 2013 to the present, Zenith Alpha thoracic stent grafts have been employed to treat 42 patients (31 men; median age, 71 years; range, 54-83 years) suffering from descending thoracic aortic disease: 34 degenerative aneurysms, 4 aortic ulcers, 2 false aneurysms following prior thoracic open repair, and 2 traumatic blunt injuries. The mean proximal neck length was 25 mm (range, 17-40 mm), with a mean access vessel diameter of 6.7 mm (range, 6-11 mm). In 11 cases, aortoiliac occlusive disease (TransAtlantic Inter-Society Consensus type B and C lesions) was present. The proximal landing was in zone 1 in 2 cases, in zone 2 in 25 cases, in zone 3 in 11 cases, and in zone 4 in 4 cases. Results Fifty-one endografts (45 proximal components and 6 distal components) were deployed in 42 patients. The endografts were deployed safely and effectively from one surgical femoral access site in all cases. In patients with associated aortoiliac disease, no adjunctive procedures for device insertion, except for predilation with balloon angioplasty in two cases, were required. No major complications related to the devices were observed in any of the patients during the postoperative course, and there was no perioperative mortality, paraparesis, or paraplegia. At 30 days, morbid events included one case of major stroke, two cases of transient acute renal failure, and one case of postimplantation syndrome. No access-related complications were recorded. Computed tomography performed within 6 months was obtained in 39 patients and confirmed 100% clinical success without device-related complications. No type I endoleaks or bird's beak effects were documented. Conclusions Our early experience shows that deployment of the new Zenith Alpha endograft from a surgical femoral access is safe and effective in treating thoracic aortic aneurysms, aortic ulcers, and traumatic blunt injuries, even in patients with small or diseased access vessels. Endograft conformance to the aorta and exclusion of the aneurysm were satisfactory. Long-term durability remains to be evaluated.