Early in Vivo Analysis of an Endovascular Stapler During Endovascular Aneurysm Repair

Abstract

The objective of this article is to describe the use and technique of a novel endostapling device used in an in vivo animal model. Six ovine underwent implantation of a Dacron endograft into the thoracic aorta followed by placement of endoclips proximally and distally. The animals were survived 35 days to evaluate the performance and safety of the endoclip in an animal model prior to clinical trials. The mean time for securing both the proximal and the distal anastomosis was 22 minutes (range 17-31 minutes). All staples were deployed, without the need for repositioning, on the first attempt. There were no complications related to the implant procedure or indwelling clips. Additionally, no endograft migration occurred. At the time of explant, staples were evaluated for depth of penetration and accuracy of placement. The staples had fully penetrated the endograft and vessel wall through the adventitia in 89% (64 of 72) of clips deployed. The staples were placed accurately, within 10 mm of the endograft proximal and distal attachments in 94% (68 of 72) of the clips deployed. Furthermore, endothelialization of the staples was present without surrounding thrombus. Implant sites were scored as normal without surrounding tissue damage by an independent pathologist. The endoclip performed well in creating proximal and distal fixation of the endograft. There were no adverse outcomes related to the endostaple. Future clinical trials should be undertaken to assess its clinical utility during endovascular aneurysm repair.