Initial Clinical Experience With the Zenith Alpha Stent-Graft

Purpose: To assess safety and short-term efficacy of endovascular repair of the thoracic aorta with the new Zenith Alpha stent-graft. Methods: Between August 2010 and May 2014, 33 patients (21 men; mean age 73.2±9.0 years) were treated Zenith Alpha stent-graft (group ZA). Outcomes of this group were compared with those of 34 patients (25 men; mean age 70.3±8.5 years) treated contemporaneously with the Zenith TX-2 for the same pathologies (group TX). The primary outcome measure was technical success. Data on iliac tortuosity, minimum access vessel diameter, and previous unsuccessful treatment with other endografts was also recorded. Results: Technical success was 93.9% in group ZA and 91.2% in group TX (p=0.67). There was no case of surgical death or conversion to open repair in either group. Two (6%) type I endoleaks occurred in group ZA and 3 (9%) in group TX (p=0.67). Three patients died within 30 days in group ZA vs. none in group TX (p=0.07). Mean minimum access vessel diameter was significantly smaller (5.07 vs. 6.65 mm, p=0.002) and iliac tortuosity indices significantly higher in group ZA (1.34 vs. 1.25, p=0.02). Access vessel complications occurred in 1 (3%) patient in group ZA and 4 (12%) patients in group TX (p=0.17). Significantly more patients in group ZA (6, 18%) were unsuccessfully treated previously with other endografts vs. none in group TX (p=0.01). Conclusion: The new Zenith Alpha appears to be equally as safe and efficacious as the Zenith TX-2 while being used in patients with demanding access vessel morphology.