A novel intrasaccular aneurysm device with high complete occlusion rate: initial results in a rabbit model.

BACKGROUND: Intrasaccular flow-disrupting devices are a safe and effective treatment strategy for intracranial aneurysms. We utilized high-frequency optical coherence tomography (HF-OCT) and digital subtraction angiography (DSA) to evaluate SEAL Arc, a new intrasaccular device, and compare the findings with the well-established Woven EndoBridge (WEB) device in an animal model of saccular aneurysms. METHODS: In a rabbit model, elastase-induced aneurysms were treated with SEAL Arc (n=11) devices. HF-OCT and DSA were performed after implant and repeated after 12 weeks. Device protrusion and malapposition were assessed at implant time and scored on a binary system. Aneurysm occlusion was assessed at 12 weeks with the WEB Occlusion Scale and dichotomized to complete (A and B) or incomplete (C and D) occlusion. The percentage of neointimal coverage after 12 weeks was quantified using HF-OCT. We compared these data to previously published historical controls treated with the gold-standard WEB device (n=24) in the same model. RESULTS: Aneurysm size and device placement were not significantly different between the two groups. Complete occlusion was demonstrated in 80% of the SEAL Arc devices, which compared favorably to the 21% of the aneurysms treated with WEB devices (P=0.002). Neointimal coverage across SEAL Arc devices was 86±15% compared with 49±27% for WEB (P=0.001). Protruding devices had significantly less neointimal coverage (P<0.001) as did incompletely occluded aneurysms (P<0.001). Histologically, all aneurysms treated with SEAL Arc devices were completely healed. CONCLUSION: Complete early aneurysm occlusion was frequently observed in the SEAL Arc treated aneurysms, with significant neointimal coverage after 12 weeks.

First Human Evaluation of Endothelial Healing after a Pipeline Flex Embolization Device with Shield Technology Implanted in Posterior Circulation Using Optical Coherence Tomography.

A 64-year-old female presented with an incidentally-discovered right posterior inferior cerebral artery (PICA) aneurysm, initially treated in 2015 by simple coiling. Follow-up demonstrated significant coil compaction that required retreatment. Retreatment was done uneventfully using a Pipeline embolization device (PED) shield deployed starting from the basilar artery and ending at the V4 segment of the vertebral artery. Eight-weeks post-deployment, a follow-up digital subtraction imaging (DSA) and intravascular imaging with optical coherence tomography were obtained. The intravascular imaging demonstrated that the flow diverter had good wall apposition and concentric neointimal growth over the braid with exception to the areas that the PED was not in contact with the endothelial wall, such as at the right PICA ostium and at the vertebrobasilar junction. The entire procedure was safe, and the patient had no complications. In this article, we describe for the first time the assessment of the status of endothelial "healing" of the PED shield at 8-weeks.