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Differences of transcatheter heart valve (THV) types and cerebral injury after TAVR are not well understood; therefore, this study investigated differences between THV types and debris captured by a cerebral embolic protection system (Claret Medical Sentinel, Santa Rosa, CA).
246 patients pooled from two prospective studies (SENTINEL IDE Trial n=100, SENTINEL-H trial n=146) were included in the analysis. Histopathologic assessment and histomorphometric analyses of debris were compared with THV types. Analyses were differentiated by particle size (≥150μm, ≥500μm, ≥1000 μm), particle count (PC), total particle area (TPA) and maximum of largest dimension (MOLD). Only commercially available THVs were included: 16% Evolut R (EvR), 15% Lotus, 59% SAPIEN 3 (S3) and 10% SAPIEN XT (XT).
Particles were captured in 99% of patients. There was a significantly higher debris related to the vascular bed (valve tissue, arterial wall, calcification) in EvR patients compared to S3 pts. 53% of all patients irrespective of valve type had at least one particle ≥1mm. Larger particles (≥500μm and ≥1000μm) were significantly more frequent in EvR than XT and S3 patients. Lotus patients with particles ≥1000μm were significantly more frequent than in S3 patients. PC, TPA and MOLD were significantly higher in both Lotus and EvR patients compared to S3 and XT.
Debris was captured in 99% of patients, of whom 53% had at least one particle of debris >1mm. Embolic debris is universal across valve types and supports the potential benefit of using cerebral embolic protection in all TAVR procedures.