Abstract
PURPOSE: The authors describe the initial clinical experience with a new device, approved by the FDA for investigation, for repair of abdominal aortic aneurysm by transfemoral endovascular insertion of an aortic graft. METHODS: Sixty-nine patients with abdominal aortic aneurysms were screened, and ten were found to be suitable for endovascular grafting. Repair was done in the operating room using general anesthesia. One femoral artery was surgically exposed, and the device, containing a premeasured graft with proximal and distal self-expanding fixation devices, was inserted with fluoroscopic control through an open arteriotomy. FINDINGS: Eight of ten patients underwent successful graft placement, and two patients required conversion to an open repair. On follow-up, six of eight patients who underwent graft placement functioned normally, with documented aneurysm thrombosis. Two patients who underwent graft placement functioned normally, with contrast computed tomography evidence of incomplete aneurysm thrombosis, but without further expansion. CONCLUSION: Transfemoral repair is safe and appears to be effective. Phase II study currently is appropriate, with need for long-term follow-up.