During valve replacement, cerebral protection systems may capture debris in up to 99% of all patients. In over half of them, these particles are >1 mm.

The particles captured during procedures in which Evolut R or Lotus valves were used were more and larger compared with those captured with the Sapien balloon-expandable valve. Beyond differences among valves, knowing that almost all patients present some kind of debris supports the eventual universal use of cerebral protection devices during TAVR.

Other recent studies had not discussed the lack of risk factors that might predict which patients would benefit more from protection systems and, without being able to select them correctly, all we could do was use these devices in all procedures. The cost/benefit relation of this is a different issue that should be assessed separately.

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In this study, recently published in J Am Coll Cardiol Intv, a cerebral protection system (Claret Medical Sentinel, Santa Rosa, California) was used in an attempt to determine whether there were differences in size and number of debris based on the different valves used. A total of 246 patients from 2 prospective studies, SENTINEL (n = 100) and SENTINEL-H (n = 146), were included. The analysis of debris captured differentiated it by particle size (≥150, ≥500, and ≥1000 μm), particle count, total particle area, and maximum of largest dimension. The valves used were Evolut R (16%), Lotus (15%), Sapien 3 (59%), and Sapien XT (10%).

There was a higher amount of debris related to the vascular bed (valve tissue, arterial wall, calcification) in patients who received an Evolut R valve compared with patients who received a Sapien 3 valve. Beyond that, all valves resulted in at least one particle >1 mm. Large particles (≥500 and ≥1000 μm) were significantly more frequent with Evolut R and Sapien 3 valves. Particles ≥1000 µm were more frequent with Lotus valves.

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Self-expanding valves presented higher particle count, total particle area, and maximum of largest dimension than both balloon-expandable models.

Conclusion

Debris was captured in 99% of patients, over half of whom had particles >1 mm. Regardless of differences in debris number and size among valves, their universal finding may support the use of cerebral protection devices in all patients undergoing TAVR.

Original title: Debris Heterogeneity Across Different Valve Types Captured by a Cerebral Protection System During Transcatheter Aortic Valve Replacement.

Reference: Tobias Schmidt et al. J Am Coll Cardiol Intv 2018;11:1262-73.

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