Purpose: This prospective study was designed to assess the technical success and outcome after patients with thoracic aortic pathology at high risk for conventional therapy were treated with the Zenith TX1 and TX2 endovascular graft.
Methods: Between 2001 and 2004, patients at high risk for conventional surgical therapy presenting with chronic aortic dissections, thoracic aneurysms, or aortobronchial or aortoesophageal fistulas were treated with a single- or multiple-piece endovascular grafts. Surgical modification of proximal or distal fixation sites was performed when necessary to establish adequate regions for device landing zones. Follow-up studies included radiographic evaluation before discharge and at 1, 6, 12, and 24 months. Aortic morphologic characteristics were determined by using three-dimensional imaging studies and centerline of flow measurements. Statistical analyses were performed with Kaplan Meier analysis to assess survival, factors predictive of poor outcome, and morphologic changes, including sac shrinkage.
Results: A total of 100 patients (42% women) were treated, including 81 aneurysms, 15 aortic dissections (with aneurysms), 2 patients with fistulous connections (1 aortobronchial and 1 aortoesophageal), 1 subclavian artery aneurysm, and 1 aortic rupture. Mean follow-up and aneurysm size were 14 months and 62 mm, respectively. Most patients (55%) had undergone prior aortic aneurysm repair. Surgical modifications were required to create adequate implantation sites in 29% patients, including 14 elephant trunk/arch reconstructions, 18 carotid-subclavian bypasses, and 4 visceral vessel bypasses. Iliac conduits were required in 19 patients. Overall mortality was 17%, and aneurysm-related mortality was 14% at 1 year. Sac regression (>5 mm maximum diameter decrease) was observed in 52% and 56% at 12 and 24 months. Growth was noted in one patient (1.6%) at 12 months. Endoleaks were detected in eight patients (8.5%) at 30 days and three patients (6%) at 12 months. Secondary interventions were required in 15 patients. Migration (>10 mm) of the proximal or distal stent was noted in three patients (6%) (two proximal and one distal), none of which required treatment or resulted in an adverse event.
Conclusions: Acceptable intermediate-term outcomes have been achieved in the treatment of high-risk patients in the setting of both favorable and challenging anatomic situations with these devices. The complexity of the patient population, in contrast to endovascular infrarenal repair, attests to the differences in the pathophysiology aortic disease in the anatomic beds.