Effects of a dual-filter-based cerebral embolic protection device in transcatheter aortic valve replacement on cerebral oxygen saturation: A prospective pilot study

Purpose: The Sentinel Cerebral Protection System (Sentinel-CPS) is increasingly used in transcatheter aortic valve replacement (TAVR). However, the impact of inserting the Sentinel-CPS inside the brain-supplying arteries on cerebral perfusion and oxygenation is unknown. Methods: Twenty patients undergoing transfemoral TAVR with (n = 10) and without (n = 10) cerebral embolic protection using the Sentinel-CPS were prospectively observed. All patients received conscious sedation and cerebral oxygen saturation (rSO₂) was continuously measured with near-infrared spectroscopy (NIRS). The cumulative perioperative cerebral desaturation was calculated for each patient by multiplying rSO₂ below an individualized desaturation threshold by time. In addition, rSO₂ values at the time of Sentinel-CPS insertion, filter positioning, and device retraction were analyzed. Results: There was no significant difference in cumulative cerebral desaturation in patients with Sentinel-CPS (median [IQR]) (0 [0/81] s%) and without (median [IQR]) (0 [0/23] s%), p =.762. A total of 6 patients (33.3%) experienced a perioperative decrease in rSO₂ below the individualized desaturation threshold (n = 3 with Sentinel-CPS, n = 3 without Sentinel-CPS; p = 1.000). Cerebral desaturation was detected during valve deployment (n = 5) and after postdilatation (n = 1). No desaturation events occurred during Sentinel-CPS insertion, filter positioning, or retraction. Conclusion: Our pilot study revealed no difference in cumulative perioperative cerebral desaturation between TAVR with and without Sentinel-CPS. Catheter- and filter-based manipulations in the brain-supplying arteries for Sentinel-CPS application were not associated with a decrease of cerebral perfusion and oxygenation.