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.