Purpose: To develop a branched stent-graft for endovascular repair of aortic arch aneurysm.
Methods: Four different prototypes of a branched aortic stent-graft were inserted into a rubber model of the human aortic arch under fluoroscopic guidance. Each prototype was tested, modified, and tested again through a series of 4 iterations. The first 3 prototypes had multiple short side branches, as docking sites for extensions into the branches of the aortic arch. The last iteration had only 1 short branch for an extension into the distal aorta and 1 long branch for direct perfusion of the innominate artery.
Results: With every re-design, the prototype aortic stent-graft became shorter, and its insertion site moved to a more proximally located arch artery. Stent-graft insertion, orientation, and extension also became quicker and easier with each change in device design. However, the only system to perform reliably was the last, which was subsequently used to treat a large, symptomatic pseudoaneurysm of the aortic arch in a high-risk patient.
Conclusions: None of our multibranched systems was simple, safe, or durable enough for insertion into the aortic arch; only an iteration that had a short branch for an extension into the distal aorta and a long branch for direct perfusion of the innominate artery could be deployed without difficulty or delay.