Midterm Results From the TRAVIATA Registry: Treatment of Thoracic Aortic Disease With the Valiant Stent Graft

Purpose: To assess early and midterm outcomes after thoracic endovascular aortic repair (TEVAFI) with the Valiant Thoracic Stent Graft. Methods: Data were reviewed retrospectively for 92 patients (69 men; mean age 65 +/- 14.5 years) who underwent TEVAR in 52.2% elective and 47.8% urgent/emergent procedures for treatment of 56 degenerative aneurysms, 32 aortic dissections, and 4 traumatic injuries at 4 German centers between June 2005 and March 2008. Results: The technical success rate was 86.9%. Through 30 days, there were 3 (3.3%) deaths. Periprocedural complications included endoleak (n=6), systemic complications (n=6), arterial rupture or dissection (n=6), device-related complications (n=5), retrograde aortic dissection (n=1), aortic rupture (n=1), spinal cord ischemia (n=1), and stroke (n=1). Cumulative survival was 95.5% at 1 year, 87.4% at 2 years, and 76.4% at 3 years. The rate of aneurysm-related mortality was 2.2% (n=2). For aneurysm and dissection patients, respectively, the rates of major complications were 9.3% and 15.6%, and secondary procedures were required in 7.4% and 12.5%. Type I endoleaks were detected in 4 aneurysm and 2 dissection patients, and graft migration occurred in 1 patient each from the aneurysm and dissection groups. No patients were converted to open surgery during follow-up. Aortic diameter reduction >5 mm was confirmed for 58.4% of patients overall. Conclusion: The high technical and clinical success, the low all-cause and aneurysm-related mortality, the negligible rates of neurological complications and spinal cord ischemia, and the low incidence of endoleak support the safety and effectiveness of TEVAR with the Valiant Thoracic Stent Graft. However, some deployment-related complications could be avoided by enhancements of the deployment mechanism. J Endovasc Ther. 2010;17:137-150