Arteriographic and pathologic evaluation of two suture-mediated arterial closure devices in a porcine model

Abstract

Purpose: To determine the acute and short-term effects the Sutura 8-F SuperStitch and Perclose 6-F Closer devices have on the femoral artery, as determined by angiography and pathologic examination.

Materials and methods: From a common carotid artery cutdown, eight pigs underwent pelvic angiography (i) before placement of bilateral common femoral artery vascular sheaths, (ii) after sheath insertion, and (iii) after device deployment. Two pigs were immediately killed; six survived 4 weeks for repeat angiography and vessel harvest.

Results: Average vessel diameter before sheath insertion was 5.9 mm +/- 0.6 and 5.8 mm +/- 0.6 for vessels with Perclose and Sutura devices, respectively. After deployment of the Sutura device, there was a 44.7% (P =.001) mean diameter reduction from preprocedural diameters, compared to a 59.3% reduction (P <.001) with the Perclose device. After deployment of the Sutura device, there was a mean vessel diameter reduction of 14.1% (P =.53) versus the diameter immediately after sheath placement. After deployment of the Perclose device, there was a mean vessel diameter reduction of 43.8% (P =.05) versus the diameter immediately after sheath placement. At 4-week angiography, all vessels returned to their original diameters before sheath insertion. Pathologic examination showed mild adventitial fibrosis creating a "fibrous hood" surrounding the suture and vessel.

Conclusions: Despite significant luminal compromise after device deployment, all vessels appeared normal on angiography at 4 weeks. Contrary to the normal angiographic findings, both devices incited periadventitial fibrosis, which created a fibrous hood around the suture and vessel.