Significant Differences in Debris Captured by the Sentinel Dual-Filter Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement Among Different Valve Types

Abstract

Objectives: The aim of this study was to evaluate the debris captured by the Claret Sentinel cerebral embolic dual-filter protection device during transfemoral transcatheter aortic valve replacement (TAVR) with different valve types. Background: Risk for embolization of debris during TAVR may vary by TAVR device. Methods: The filters of 100 consecutive patients were collected and captured debris was analyzed by histopathology and histomorphometry. Three valve types were implanted: the balloon-expandable Edwards SAPIEN 3 (n = 42), the self-expandable Medtronic Evolut R (n = 35), and the mechanically implantable Boston Scientific Lotus (n = 23). Results: Among the 3 groups there was no difference in baseline data, including Society of Thoracic Surgeons score for mortality, calcification, or pre-dilation. The type of captured debris did not differ among the 3 valve types in the proximal or distal filter. With the balloon-expandable valve, there were significantly more patients with large debris measuring ≥1,000 μm. The number of particles in the proximal filter was significantly lower with the Lotus (89.8 ± 106.3) compared with the Evolut R (187.3 ± 176.9) and Edwards SAPIEN 3 (172.3 ± 133.5) valves (p = 0.035). Total tissue area in the proximal filter was significantly smaller for the Lotus compared with the other 2 valve types (7.1 ± 6.3, 20.1 ± 19.0, and 21.3 ± 15.1 mm2; p = 0.0014). In contrast, for the distal filter, there were no differences with respect to valve type for total tissue area, particle size, and number of particles. Conclusions: A significant difference was observed in the size and number of captured tissue particles with the double-filter embolic protection device among different valve types in patients undergoing TAVR. The largest particles were observed in patients treated with a balloon-expandable valve.