Evaluation of VIABAHN^Ⓡ Endoprosthesis for Thoracic, Abdominal, and Pelvic Artery Injuries

Purpose: To evaluate the efficacy and safety of the GORE^Ⓡ VIABAHN^Ⓡ Endoprosthesis (stent graft) for traumatic or iatrogenic vessel injury. Material and Methods: This prospective, multicenter, cohort study for post-marketing clinical surveillance was conducted in Japan. Efficacy and safety endpoints included successful device implantation, primary and secondary hemostasis of injury, 1-month and 1-year survival rate, and at 1-, 6-, 12-months post-procedure, primary and secondary patency rates, antiplatelet drug administration, and serious adverse events. Results: In 37 patients (mean age 73.3±12.5 years; 22 males; 59.5%), 38 vessel injuries were evaluated. Primary treated arteries were visceral, subclavian, and iliac arteries; 86.8% (33/38) were iatrogenic, and 13.2% (5/38) were traumatic vessel injury. Iatrogenic injury included pseudoaneurysm (63.6%), perforation (24.4%), rupture (15.2%), dissection (12.1%), or fistula (3.0%). Technical success in 36 patients (36/37; 97.3%) with 37 vessels (37/38; 97.4%), and primary and secondary hemostasis in all patients were achieved. Primary patency at 1-, 6-, and 12-months was 89.1%, 84.8%, and 80.6%, and secondary patency was 91.5%, 87.3%, and 82.4%, respectively. The Kaplan-Meier survival estimate was 94.4% through 1 month and 75.9% through 1 year. No device-related deaths occurred. Through 12 months, of the 19 serious adverse events (13 patients), three serious adverse events were judged by the investigator to be device-related (vascular stent graft stenosis) or procedure-related (device occlusion and cerebellar infarction). Conclusions: The use of the VIABAHN stent graft for vessel injury was safe and effective in this study. Successful hemostasis was achieved through 1 month. Through 1 year, no device-related deaths were reported.