Filling of the aneurysmal sac with DEAC-glucosamine in an animal model of abdominal aortic aneurysm following stent-graft repair.

Aim: The aim of this study was to present the preliminary results of a technique of abdominal aortic aneurysm (AAA) sac filling in an attempt to obliterate the sac in a swine AAA model, using deacetylated-poly-N-acetyl glucosamine (DEAC-poly-N-acetyl glucosamine).

Methods: Eleven Yucatan pigs, 6 months of age, 40 kg -60 kg, were used to create an AAA with a Dacron pouch implanted surgically and left to mature for 2 weeks. One animal was used to establish the AAA creation procedures. Eight animals were used for AAA sac filling; of the 8 subjects 2 were used for acute studies, and 6 for longer-term studies. Two additional animals were used as controls without polymer sac filling. Two weeks after the AAA creation, a 13 mmx5.5 cm straight tube AneuRx stent-graft was placed to exclude the aneurysm. The aneurysmal sac was filled with a polymer, DEAC-poly-N-acetyl glucosamine at 1.5%, 70% deacetylated, mixed with iohexol. There was filling of a lumbar artery by the polymer in 2 animals. Endpoints were at 1, 2, 4, 6, 12 and 24 weeks, in the chronic study animals and 6 and 12 weeks in the control subjects, procedures consisting of aortography followed by necropsy and pathologic examination.

Results: The AAA creation and aneurysm sac filling was successful in all animals. An organized thrombus layer of about 2 mm in thickness was observed in all subjects along the Dacron aneurysm wall. All aneurysms were angiographically patent at the time of treatment, but fresher thrombus within the sac was seen in 4 subjects before the polymer injection. The stent-graft placement excluded the AAA sac and the polymer injection filled all AAA sacs. The AAA sac had acquired a firm rubbery consistency at the time of necropsy. There was mild inflammatory reaction to the Dacron material in the surrounding tissues and within the sac, to a lesser extent. Two animals developed paralysis of the hind limbs following treatment, most likely related to spinal ischemia, and were used as acute subjects. There was no recanalization of the aneurysm sac, during the follow-up time, ranging from 1 to 24 weeks in the treatment or control subjects. There was a 25% shrinkage of the AAA sac at 6th, 40% at 12th week and 75% by the 24th week. The 2 control subjects showed shrinkage of less than 25% at 6 and 12 weeks. There was replacement of the polymer/thrombus complex by connective tissue, fat tissue with capillary neovascularization in the treated subjects. Fibrosis and calcifications were also detected within the sac, mostly around the stent-graft and in contact with the aortic wall starting at 4 weeks. Control subjects did not show replacement of the thrombus by connective tissue or neovascularization.

Conclusion: The results of this preliminary study support the aneurysm sac filling as a potential tool to exclude the aneurismal sac, promoting shrinkage of the AAA. DEAC -poly-N-acetyl glucosamine promotes clotting within the AAA sac with progressive replacement by connective tissue and neovascularization and may have a potential to prevent endoleaks. The polymer is easy to use, and it seems to have adequate gradual long-term replacement properties, preventing aneurysm sac recanalization.