One-year outcomes from the international multicenter study of the Zenith Alpha Thoracic Endovascular Graft for thoracic endovascular repair

Objective: This study evaluated the safety and effectiveness of the Zenith Alpha Thoracic Endovascular Graft (Cook Medical, Bloomington, Ind) for the treatment of descending thoracic aortic aneurysms and large ulcers. Methods: The Zenith Alpha Thoracic Endovascular Graft, with a 16F to 20F delivery system, was developed to address vascular access issues associated with larger-profile devices and to increase conformability in tortuous anatomy. This prospective, nonrandomized, multicenter study was conducted in Europe, Japan, and the United States. The main anatomical inclusion criteria included proximal neck seal zone of >= 20 mm, aortic arch radius of >= 20 mm, and a neck diameter of 15 to 42 mm. Patients were evaluated preprocedure, predischarge, and postdischarge 1, 6, and 12 months and yearly thereafter through 5 years. Results: Between March 2010 and January 2013, 110 patients (64 men and 46 women; mean age, 72 +/- 10 years) were enrolled in the study for the treatment of descending thoracic aortic aneurysms (n = 90) or ulcers (n = 20). Access was percutaneous in 36% (40 of 110) of patients. The study device was successfully implanted in all but two patients (both due to inability to gain access or advance to the target treatment site). There was no 30-day mortality. Five deaths occurred <= 1 year (only one was aneurysm-related by independent adjudication), resulting in a 95% freedom from all-cause mortality and a 99% freedom from thoracic aortic aneurysm-related mortality. At one or more time points <= 1 year, type I endoleak (all distal) was observed in 4 patients, type III endoleak in 2, and aneurysm growth in 4. Five patients experienced stroke <= 1 year (2 procedure-related). No aortic rupture, paraplegia, paralysis, or permanent spinal cord injury was observed <= 1 year. Conclusions: Early outcomes after Zenith Alpha implantation appear promising and suggest expanded thoracic endovascular aortic repair applicability in patients with smaller access vessels. Longer-term follow-up is ongoing.