PURPOSE: To evaluate the intra-operative performance and clinical outcome of a new commercially available stent-graft for the treatment of thoracic aortic diseases. METHODS AND PATIENTS: From January 2003 to October 2004, 45 consecutive patients received endovascular treatment with the Zenith TX1 device for diseases of the thoracic aorta at a single center in northern Italy. Indications included disease of the descending thoracic aorta in 26 cases, of the aortic arch in 17 cases and of the thoraco-abdominal aorta in two cases. We treated 38 atherosclerotic aneurysms, two post-traumatic aortic ruptures, two penetrating ulcers, two chronic dissections and one case was treated for aortic bleeding after voluntary acid ingestion for attempted suicide. General anesthesia was used in 20 cases. Combined or hybrid endovascular and open surgical repair was performed in 11 patients. Mean follow-up was 7 months (range 1-22 months). RESULTS: Technical success was obtained in 44 patients (98%). One primary type I endoleak occurred (2%). ICU was used in 12 cases with a mean stay of 1 day. The mean hospital stay was 6 days (range 4-13 days). There were no hospital deaths or strokes but one transient paraplegia (2%). A type II endoleak was observed in one case and resolved spontaneously 1 month later. No aneurysm enlargement, endograft migration or structural failures were observed during follow-up. Two late unrelated-deaths were observed. CONCLUSIONS: This stent-graft does not fulfill all the characteristics of the ideal graft, however, it proved to be safe and allowed satisfactory short term results in this group of patients treated at a single center.
PURPOSE: To evaluate the intra-operative performance and clinical outcome of a new commercially available stent-graft for the treatment of thoracic aortic diseases. METHODS AND PATIENTS: From January 2003 to October 2004, 45 consecutive patients received endovascular treatment with the Zenith TX1 device for diseases of the thoracic aorta at a single center in northern Italy. Indications included disease of the descending thoracic aorta in 26 cases, of the aortic arch in 17 cases and of the thoraco-abdominal aorta in two cases. We treated 38 atherosclerotic aneurysms, two post-traumatic aortic ruptures, two penetrating ulcers, two chronic dissections and one case was treated for aortic bleeding after voluntary acid ingestion for attempted suicide. General anesthesia was used in 20 cases. Combined or hybrid endovascular and open surgical repair was performed in 11 patients. Mean follow-up was 7 months (range 1-22 months). RESULTS: Technical success was obtained in 44 patients (98%). One primary type I endoleak occurred (2%). ICU was used in 12 cases with a mean stay of 1 day. The mean hospital stay was 6 days (range 4-13 days). There were no hospital deaths or strokes but one transient paraplegia (2%). A type II endoleak was observed in one case and resolved spontaneously 1 month later. No aneurysm enlargement, endograft migration or structural failures were observed during follow-up. Two late unrelated-deaths were observed. CONCLUSIONS: This stent-graft does not fulfill all the characteristics of the ideal graft, however, it proved to be safe and allowed satisfactory short term results in this group of patients treated at a single center.