Long-Term Data Show Durability of TEVAR in High-Risk Patients
May 9, 2017—Long-term data on the safety and durability of thoracic endovascular aortic repair (TEVAR) with the Zenith TX1 and TX2 devices (Cook Medical) were published by Jocelyn M. Beach, MD, et al in the Journal of Vascular Surgery (JVS; 2017;65:1287–1296). This prospective investigational device exemption trial, which is sponsored and led by Principal Investigator Matthew J. Eagleton, MD, of the Cleveland Clinic in Cleveland, Ohio, sought to evaluate the long-term outcomes of TEVAR in high-risk patients with descending thoracic aortic pathology.
High-risk patients treated with thoracic endografts from 2001 to 2011 were enrolled in the trial. Investigators performed three-dimensional reconstructions, and measurements were performed on CT scans acquired before discharge and at 1, 6, and 12 months, then yearly thereafter.
As summarized in JVS, the study included 200 patients (median age, 70 years), with 171 treated for thoracic aneurysm, 28 for chronic dissection, and one for aortobronchial fistula. Patients were monitored for an average of 4.8 ± 3.3 years, and 93 (46.5%) patients were monitored for > 5 years.
Operative mortality was 6.5%. Survival at 30 days and at 1, 5, and 9 years was 94%, 85.8%, 55.6%, and 31.4%, respectively. Freedom from aneurysm-related death at 30 days and at 1, 5, and 9 years was 94%, 92.4%, 91.7%, 91.7%, respectively.
Sixty-one endoleaks occurred in 54 (28%) patients. Sixty-seven reinterventions were performed in 50 patients. Overall freedom from reintervention was 87.9%, 82.9%, 75.5%, and 64% at 30 days, 1, 5, and 9 years, respectively. There were 47 (70%) reinterventions related to thoracic aneurysms (35 were endovascular procedures), and 30 reinterventions were performed to correct endoleaks at a median of 1.4 years (interquartile range, 0.2–5.0 years).
The investigators concluded that 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, advised the investigators in JVS.