Because of high morbidity and mortality of open repair of abdominal aortic aneurysms (AAAs), an endovascular approach to bypassing AAAs with supported (stented) endografts inserted via femoral artery sheaths has been developed. Three major complications occur with these endografts: 1) a leak can develop between the endograft and the adjacent aorta; 2) the endograft can migrate distally out of the aortic neck; and 3) the juxtaposition of fabric and metal struts can lead to complications (fraying, strut fracture). An Endostaple has been developed that will provide attachment of the endograft to the full thickness of the aortic wall. This Endostaple is currently in an FDA approved Phase I pilot study to determine safety and efficacy in treating 15 humans for proximal Type I endoleak in patients with endograft treatment of their AAA. While Endostaple treatment of leaks and prevention of migration are highly likely to be successful, supported endografts, unconstrained by adjacent arterial wall as they traverse the lumens of abdominal aneurysms, are likely to continue to have problems with strut/fabric fraying or strut fracture. Moreover, supported endografts are frequently not suitable for AAA patients whose aortic neck is wide, short, or severely angulated. Finally, the cost of each endograft exceeds $10,000. Therefore, for reasons of suspect durability, somewhat limited applicability, and high cost of supported endografts, it is important to evaluate other methods of endovascular treatment of AAAs. The goal of the proposed project is to develop a device and method of 1) inserting an unsupported bifurcation endograft through an 18 French insertion sheath, 2) opening the proximal portion of the tube portion within a simulated aortic neck, 3) holding the graft in place while Endostaples are placed circumferentially, 4) separating the holding mechanism from the endograft in a safe and reliable manner, and 5) withdrawing the holding mechanism back into the insertion sheath to facilitate safe removal. Such a device/method would, to a great extent, emulate the proven and durable approach used in the open repair technique but would incorporate the advantages of lower morbidity and mortality provided by the endovascular approach. Using such a device/method would allow more patients with AAAs to be treated effectively; it would lower the cost of endovascular repair of AAAs; and it will likely increase the long-term safety of endovascular treatment of AAAs.
Thesaurus Terms: aorta aneurysm, biomedical equipment safety, blood vessel prosthesis, endarterectomy, method development, surgery material /equipment clinical biomedical equipment, patient safety /medical error, postoperative complication, therapy adverse effect bioengineering /biomedical engineering, medical implant science
