Evaluation of pressure transmission and intra-aneurysmal contents after endovascular repair using the Trivascular Enovus expanded polytetrafluoroethylene stent graft in a canine model of abdominal aortic aneurysm.

OBJECTIVE: Endotension has been defined as persistently increased pressure within the excluded sac of an abdominal aortic aneurysm (AAA) resulting in increasing aneurysm size after endovascular repair in the absence of endoleak. Devices that use expanded polytetrafluoroethylene (ePTFE) have been associated with the development of endotension and continued AAA enlargement. In this study, intra-aneurysmal pressure and aneurysm content were evaluated after endovascular repair with the Enovus ePTFE stent graft in a canine model.

METHODS: Prosthetic ePTFE aneurysms, each containing a solid-state, strain-gauge pressure transducer, were implanted in the infrarenal aorta of 13 mongrel dogs (25-35 kg). A second pressure transducer was inserted into the native aorta for systemic arterial pressure measurement. The stent graft was then deployed to exclude the aneurysm via distal aortic access. Comparison was made among three distinct stent grafts: the Trivascular Enovus (nonporous ePTFE; four animals), the original Gore Excluder (porous ePTFE; five animals), and the Medtronic AneuRx (Dacron; four animals). Daily systemic and intra-AAA pressures were measured for 4 weeks. Intra-aneurysmal pressures were indexed to simultaneously measured systemic pressures. After 4 weeks, the aorta, the prosthetic aneurysm, and its contents were harvested, photographed, and processed for histologic investigation with hematoxylin and eosin and Masson trichrome staining.

RESULTS: Within 24 hours after exclusion, the mean arterial pressure and pulse pressure within the AAA sac tapered to less than 20% of systemic pressure for all three stent graft types. Throughout the postoperative period, significantly lower indexed intra-aneurysmal pressures were present in the Enovus- and AneuRx-treated aneurysms as compared with those treated with the original Excluder stent graft (0.05 +/- 0.04, 0.16 +/- 0.06, and 0.06 +/- 0.03 for the Enovus, Excluder, and AneuRx, respectively). Histologic analysis of the Enovus-treated aneurysms demonstrated intraluminal content characterized almost entirely by erythrocytes and infrequent white blood cells without the fibrin organization-characteristics of acute or chronic thrombus. This contrasted with the content of the Excluder-treated aneurysms, which contained poorly organized fibrin deposition suggestive of acute thrombus, and of the AneuRx-treated aneurysms, which demonstrated mature, well-organized collagenous connective tissue.

CONCLUSIONS: Exclusion of the AAA with the Enovus stent graft resulted in nearly complete elimination of intra-aneurysmal pressure in this model. Histologic analysis of the aneurysm content further suggested complete exclusion, including elimination of circulating clotting factors and fibroblasts responsible for thrombus formation and reorganization. Ultimately, clinical evaluation will be necessary to demonstrate the effectiveness of this stent graft in preventing the development of endotension.