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

Abstract

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.

Use of a cerebral protection device to facilitate pulmonary vein isolation in a patient with left atrial mass arising from the interatrial septum

“…Mechanical devices, such as the FDA‐approved dual‐filter Sentinel™CPD are increasingly used to reduce cerebral embolization during TAVR. The system is inserted through the right radial or brachial artery with one filter deployed in the brachiocephalic (proximal target vessel) and the other in the left common carotid artery (distal target vessel) 9 . It consists of a six French catheter carrying two cone‐shaped, biocompatible polyurethane filters equipped with 140 µm pores to capture and remove potential debris.…”

The efficacy of different types of cerebral embolic protection device during transcatheter aortic valve implantation: a meta-analysis

“…According to the operating principle of CEPD, using CEPD during TAVI can prevent the entry of various emboli (such as thrombus, vascular fragments, heart tissue) into the cerebral arteries, thereby reducing the incidence of stroke (6)(7)(8).…”

Efficacy of Cerebral Embolic Protection Device During Transcatheter Aortic Valve Implantation: An Updated Meta-Analysis

“…into cerebral arteries, thereby reducing the stroke rate. [6][7][8] Published randomized controlled trials (RCTs) and retrospective cohort studies were insu cient to demonstrate that CEPD avoids or reduces stroke, death and other complications in patients after TAVI. Not only that, the published meta-analysis may not draw rm conclusions due to insu cient sample size and short follow-up time [4,5,9,10] .…”