Endovascular exclusion of thoracic aortic aneurysms with the 1- and 2-component Zenith TX2 TAA endovascular grafts: analysis of 2-year data from the TX2 pivotal trial.

PURPOSE: To compare the midterm results of endovascular treatment of thoracic aortic aneurysms and ulcers in patients who received either a 1-component or 2-component Zenith TX2 stent-graft.

METHODS: Data were gathered from a prospectively maintained registry for the Zenith TX2 pivotal trial. Among 158 patients who underwent thoracic endovascular aortic repair (TEVAR) between March 2004 and July 2006, 64 received a 1-component stent-graft (group 1) and 94 patients a 2-component device (group 2).

RESULTS: In group 2, there were more men (79% vs. 63%; p = 0.03), and the patients had more diagnosed (p<0.01) and previously repaired (p<0.01) abdominal aortic aneurysms. Aneurysms in group 2 were significantly larger in both diameter (63 vs. 56 mm, p<0.01) and length (157 vs. 113 mm, p<0.01). Percent of thoracic aorta covered by the stent-graft was greater in group 2 (80% vs. 50%, p<0.01). Patients in group 2 had a significantly longer operation time (124±48 vs. 100±39 minutes, p<0.01) and significantly increased estimated blood loss during the procedure (248±359 vs. 169±139 mL, p = 0.05). Procedural success at 30 days was 95% in group 1 and 85% in group 2 (p = 0.06). Postoperative paraplegia and paraparesis were not observed in group 1, but 9 patients in group 2 (p = 0.01) were affected. Treatment success, endoleak, migration, secondary intervention rate, and all-cause and aneurysm-related mortality were not significantly different between the groups at 30 days, 1 year, and 2 years.

CONCLUSION: TEVAR using 1 or 2 TX2 components has similar results in terms of mortality and midterm treatment success. Patients treated with 2 components showed increased perioperative morbidity, including paraplegia, which may be related to the greater extent of graft coverage required in this patient group, as well as to male gender, previous aortic repair, longer operating time, and increased blood loss.