Clinical outcomes of the Seal® thoracic stent graft for traumatic aortic injury in a Korean multicenter retrospective study.

Background: Thoracic endovascular aneurysm repair (TEVAR) has been used as a primary treatment for blunt traumatic aortic injury (TAI). However, the outcomes of midterm surveillance of Seal (R) stent-graft durability for TAI have not been extensively studied. Thus, we aimed to report the midterm outcomes of TEVAR using the Seal (R) stent graft for blunt TAI. Methods: Patients with blunt TAI treated with TEVAR using the Seal (R) thoracic stent graft between 2007 and 2013 in Korea were included. Midterm outcomes included technical/clinical success, in-hospital death, aorta/procedure/device-related adverse events, secondary procedures, and 30-day and all-cause mortality. Results: A total of 99 patients (54% men; mean age, 48 years) were included. Grade III or higher injuries were present in 95% of patients, including 15 free ruptures of the thoracic aorta, and 64% of injuries were located in zone III. The median procedure and hospitalization duration were 90 min and 11 days, respectively. The technical success rate was 98%. The number of in-hospital mortalities (n = 8) and stroke (n = 2) were observed at 30 days. Late stroke and paraplegia (>30 days) were not observed during the mean 49 +/- 26 months of follow-up (median, 48 months; range, 0-117 months). There were no aorta-related mortalities or conversions to open repair. Secondary procedures were performed in 8 patients, all of which were carotid-subclavian bypasses for delayed left subclavian occlusion. The all-cause mortality rate was 5% at 30 days and 8% at 1 year. The survival rate was 95% at 30 days, 92% at 1 year, 92% at 3 years, and 89% at 5 years. One type Ia endoleak occurred at 18 months after the procedure. Conclusions: TEVAR with the Seal (R) stent graft for TAI showed favorable midterm outcomes. The incidence of major adverse events after the procedure was low.