Disappointing results with a new commercially available thoracic endograft

Introduction: New devices for endovascular treatment of thoracic aortic diseases were recently approved for clinical use by European authorities, obtaining the Conformite Europeenne (CE) mark. In all patients who underwent endovascular treatment of a thoracic aortic disease in 2002, we used a new CE-marked device, the Endofit stent graft. The device is constituted of nitinol stents and polytetrafluoroethylene fabric, and has a simple design and delivery system. Methods: During 2002, 11 patients (mean age, 75 years; range, 66-85 years) underwent treatment of atherosclerotic aneurysm (n = 9), chronic type B dissection (n = 1), and intramural hernatoma (n = 1). Disease involved the descending thoracic aorta in 7 patients and the distal aortic arch in 4 patients. Results: In all cases the Endofit stent grafts were successfully deployed in the intended position. No postoperative paraplegia or paraparesis was recorded. There were two in-hospital deaths: 1 patient died in the operating room (postmortem examination showed a kinked graft); and the other patient died in the intensive care unit on postoperative day 30, after an intraoperative stroke. One surgical conversion was performed 2 weeks after the procedure, because of total collapse of the graft due to rupture of three stents. Other graft-related complications included type I endoleak (n = 2), type 11 endoleak (n = 1), and incomplete opening of the device (n = 1). Conclusion: Endovascular treatment of thoracic disease with the Endofit graft in this small heterogeneous group of patients resulted in several complications, which may arise from both the delivery system and the graft itself. At present, other commercially available endografts may be safer for endovascular treatment of thoracic aortic diseases.