Transcatheter aortic valve replacement (TAVR), a key treatment for severe aortic stenosis, carries a concerning stroke rate of 2-3%, largely due to embolic debris. In the SafePass 2 study, Yale researchers evaluated the novel Emboliner device, which was designed to protect both cerebral and bodily vasculature from such debris.
This multicenter, single-arm study assessed the Emboliner's safety and effectiveness in capturing debris during TAVR. All 29 analyzed filters captured debris, indicating a large embolic risk from the procedure. The team found that patients with atrial fibrillation experienced a greater embolic burden, and self-expanding valves generated more particles. Contrary to previous assumptions, preprocedural CT angiography did not predict the number of debris articles generated from the procedure.
The study underlines the importance of identifying patients at higher risk of stroke and considering cerebral embolic protection devices in TAVR.
To learn more, read the article, “Predictors of Cerebral Embolic Debris During Transcatheter Aortic Valve Replacement: The SafePass 2 First-in-Human Study.”
Grubman D, Ahmad Y, Leipsic JA, Blanke P, Pasupati S, Webster M, Nazif TM, Parise H, Lansky AJ. Predictors of Cerebral Embolic Debris During Transcatheter Aortic Valve Replacement: The SafePass 2 First-in-Human Study. Am J Cardiol. 2023 Nov 15;207:28-34. doi: 10.1016/j.amjcard.2023.08.137. Epub 2023 Sep 16. PMID: 37722198.