Cerebral Embolic Protection in TAVR: How Many Patients Are Eligible for the Implantation of a Two-Filter System?

Objectives: Brain protection in transcatheter aortic valve replacement (TAVR) using the dual-filter based Claret Sentinel embolic protection device (CS-EPD) has gained importance over the past years. However, there are no data about the percentage of patients potentially eligible for CS-EPD treatment.

Methods: We retrospectively performed a multislice computed tomography (MSCT) examination and data review of all patients undergoing a TAVR procedure in 2017 (n = 317). MSCT evaluation included the assessment of aortic arch anatomy and the vascular dimensions of the brachiocephalic (proximal target vessel) and left common carotid artery (distal target vessel). Data analysis focused on comorbid conditions, precluding 6-French sheath radial access and filter deployment due to history of previous artery interventions. Potential contraindications for CS-EPD usage were defined according to the instructions for use.

Results: MSCT and data evaluation revealed CS-EPD compatibility in 61.5% of patients (n = 195). One or more contraindications for the usage of the device were found in 38.5% of patients (n = 122) due to the following reasons: (1) Measured diameters of the filter-landing zones outside the recommended ranges of < 9 and >15 mm in the brachiocephalic and/or < 6.5 and >10 mm in the left common carotid artery (n = 115), mostly carotid dimensions too small for filter deployment (< 6.5 mm, n = 85). (2) Presence of a significant subclavian artery stenosis (n = 2) or an aberrant right subclavian artery (n = 3) as determined by MSCT precluding device implantation. (3) Pathologic disorders prohibiting catheter insertion because of hypersensitivity to nickel–titanium (n = 1), a right radial artery occlusion (n = 1), or a history of previous left common carotid artery intervention (n = 5).

Conclusion: Our study is the first to analyze the percentage of candidates potentially suitable for CS-EPD usage, revealing device compatibility in approximately two-thirds of patients. The most common finding for patient exclusion was an inappropriate diameter of the left carotid artery in the target-landing zone. Future device developments should address this limitation.