Analysis of neointima development in flow diverters using optical coherence tomography imaging

BACKGROUND Flow diverters are used for the treatment of intracranial aneurysms. Surface modification may decrease the thrombogenicity of flow diverters but the details are unknown. Optical coherence tomography (OCT) is an intravascular imaging test with high resolution which identifies neointimal growth over stents. We compared the development of neointima in a flow diverter and stents with and without surface modification in a swine model. METHODS In this study we implanted four devices (two in each carotid artery) in four pigs. The devices used were the Pipeline Flex embolization device (PED Flex, n=6), PED with Shield technology (PED Shield, n=6), and Solitaire AB (n=4). Serial carotid angiographic and OCT images were obtained on days 0, 7, 14, and 21. The data analyzed included: neointimal area (lumen area - stent area), neointimal ratio ([lumen area - stent area]/stent area), and the neointimal thickness ratio (minimum neointimal thickness/maximum neointimal thickness). RESULTS There was no significant difference in where neointima formation was initiated in relation to the implanted device (distal vs middle vs proximal). The PED Shield had a trend towards earlier endothelial formation at day 7. By day 21 the neointimal ratio was significantly higher for the PED Flex and PED Shield devices than for Solitaire (p<0.05 and p<0.01, respectively). The neointimal thickness ratio was significantly higher with PED Shield than with PED Flex and Solitaire (p<0.05 and p<0.01, respectively). CONCLUSIONS OCT enabled us to follow and compare in vivo the development of neointima over implants. PED Shield showed a similar neointimal volume to PED Flex and more concentric neointima.