Durable outcomes of thoracic endovascular aortic repair with Zenith TX1 and TX2 devices

Objective: Long-term data regarding the safety and durability of thoracic endovascular aortic repair (TEVAR) are limited. The study objective was to evaluate the long-term outcomes of TEVAR in high-risk patients with descending thoracic aortic pathology. Methods: High-risk patients were treated with thoracic endografts (2001-2011) under a prospective, physician-sponsored, investigational device exemption trial. Three-dimensional reconstructions and measurements were performed on computed tomography scans acquired before discharge, at 1, 6, and 12 months, and then yearly thereafter. Results: The study included 200 patients, of whom 171 were treated for thoracic aneurysm, 28 for chronic dissection, and 1 for aortobronchial fistula. Patients were monitored for an average of 4.8 +/- 3.3 years, and 93 (46.5%) were monitored for >5 years. Operative mortality was 6.5%. Survival at 30 days and at 1, 5, and 9 years was 94.0%, 85.8%, 55.6%, and 31.4%, and freedom from aneurysm-related death was 94.0%, 92.4%, 91.7%, 91.7%, respectively. Sixty-one endoleaks occurred in 54 patients (28%). Sixty-seven reinterventions were performed in 50 patients. Overall freedom from reintervention at 30 days, 1, 5, and 9 years was 87.9%, 82.9%, 75.5%, and 64.0%, respectively. Forty-seven reinterventions (70%) were thoracic aneurysm-related, 35 (74%) of which were endovascular procedures. Thirty of these were to correct endoleaks at a median of 1.4 years (interquartile range, 0.2-5.0 years). Conclusions: TEVAR is durable and associated with high long-term aneurysm-related survival. Long-term imaging follow-up remains critical to identify endoleaks or rare device durability issues, most of which can be monitored or managed with endovascular therapies.