Roham Moftakhar1, Fangmin Xu2, Beverly Aagaard-Kienitz3, Daniel W Consigny3, Julie R Grinde3, Kevin Hart4, Claire E Flanagan2, Wendy C Crone5, Kristyn S Masters2. 1. Department of Neurological Surgery, Rush University Medical Center, Chicago, Illinois, USA. 2. Department of Biomedical Engineering, University of Wisconsin-Madison, Madison, Wisconsin, USA. 3. Department of Radiology, University of Wisconsin-Madison, Madison, Wisconsin, USA. 4. Department of Engineering Physics, University of Wisconsin-Madison, Madison, Wisconsin, USA. 5. Department of Biomedical Engineering, University of Wisconsin-Madison, Madison, Wisconsin, USA Department of Engineering Physics, University of Wisconsin-Madison, Madison, Wisconsin, USA.
Abstract
OBJECTIVE: Current endovascular technology does not offer a perfect solution for all cerebral aneurysms. Our group has built two versions of a novel aneurysm intrasaccular occlusion device (AIOD) to address the drawbacks associated with current occlusion devices. The objective of the present study was to perform pilot proof of concept in vivo testing of this new AIOD in swine and canines. METHODS: Two configurations of the AIOD, termed 'coil-in-shell' and 'gel-in-shell', were implanted in surgically created sidewall aneurysms (n=4) in swine for acute occlusion studies, as well as sidewall (n=8) and bifurcation aneurysms (n=3) in canines to assess long term occlusion efficacy. Occlusion at all time points (immediate, 6 weeks, and 12 weeks) was evaluated by angiography. Neointimal healing at 12 weeks post-implantation in canines was examined histologically. RESULTS: Angiographic analysis showed that both the coil-in-shell and gel-in-shell devices achieved complete aneurysm occlusion immediately following device delivery in sidewall aneurysms in swine. In longer term canine studies, initial occlusion ranged from 71.3% to 100%, which was stable with no recurrence in any of the sidewall aneurysms at 6 or 12 weeks. Histological analysis at 12 weeks showed mature fibromuscular tissue at the neck of all aneurysms and no significant inflammatory response. CONCLUSIONS: The AIOD tested in this study showed promise in terms of acute and chronic occlusion of aneurysms. Our findings suggest that these devices have the potential to promote robust tissue healing at the aneurysm neck, which may minimize aneurysm recurrence. Although proof of principle has been shown, further work is needed to deliver this device through an endovascular route. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
OBJECTIVE: Current endovascular technology does not offer a perfect solution for all cerebral aneurysms. Our group has built two versions of a novel aneurysm intrasaccular occlusion device (AIOD) to address the drawbacks associated with current occlusion devices. The objective of the present study was to perform pilot proof of concept in vivo testing of this new AIOD in swine and canines. METHODS: Two configurations of the AIOD, termed 'coil-in-shell' and 'gel-in-shell', were implanted in surgically created sidewall aneurysms (n=4) in swine for acute occlusion studies, as well as sidewall (n=8) and bifurcation aneurysms (n=3) in canines to assess long term occlusion efficacy. Occlusion at all time points (immediate, 6 weeks, and 12 weeks) was evaluated by angiography. Neointimal healing at 12 weeks post-implantation in canines was examined histologically. RESULTS: Angiographic analysis showed that both the coil-in-shell and gel-in-shell devices achieved complete aneurysm occlusion immediately following device delivery in sidewall aneurysms in swine. In longer term canine studies, initial occlusion ranged from 71.3% to 100%, which was stable with no recurrence in any of the sidewall aneurysms at 6 or 12 weeks. Histological analysis at 12 weeks showed mature fibromuscular tissue at the neck of all aneurysms and no significant inflammatory response. CONCLUSIONS: The AIOD tested in this study showed promise in terms of acute and chronic occlusion of aneurysms. Our findings suggest that these devices have the potential to promote robust tissue healing at the aneurysm neck, which may minimize aneurysm recurrence. Although proof of principle has been shown, further work is needed to deliver this device through an endovascular route. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Entities:
Keywords:
Aneurysm; Bioactive; Device; Liquid Embolic Material
Authors: Brian L Hoh; Hanain Z Fazal; Siham Hourani; Mengchen Li; Li Lin; Koji Hosaka Journal: J Neurointerv Surg Date: 2017-04-27 Impact factor: 5.836