Key result
Navitor TAV linked to ~2.5-fold higher 30-day HALT incidence vs. Sapien and Evolut valves.
Why the study?
Hypoattenuating leaflet thickening has been associated with implanted transcatheter aortic valve eccentricity, but its relationship with valve type (balloon-expandable vs. self-expandable) or design (supra-annular vs. intra-annular) remained unclear.
Does transcatheter aortic valve replacement with the Navitor prosthesis affect the incidence of hypoattenuating leaflet thickening (HALT) and valve eccentricity compared to Sapien and Evolut prostheses in patients undergoing TAVR?
Observational (n=125)
Does transcatheter aortic valve replacement with the Navitor prosthesis affect the incidence of hypoattenuating leaflet thickening (HALT) and valve eccentricity compared to Sapien and Evolut prostheses in patients undergoing TAVR?
The self-expandable, intra-annular Navitor transcatheter aortic valve is associated with greater leaflet-level eccentricity and a significantly higher 30-day incidence of hypoattenuating leaflet thickening (HALT) compared to Sapien and Evolut valves.
Navitor may raise early HALT risk via eccentricity; hypothesis-generating and should not yet change TAVR valve selection.
Background Hypoattenuating leaflet thickening (HALT) has been associated with the eccentricity of implanted transcatheter aortic valve (TAV). However, its relationship with valve type (balloon-expandable vs. self-expandable) or valve design (supra-annular vs. intra-annular) remains unclear. The purpose of our study was to investigate the incidence of HALT and valve eccentricity among TAV series (Sapien, Evolut, and Navitor). Methods We retrospectively evaluated 125 consecutive patients (Sapien: n = 54, Evolut: n = 39, Navitor: n = 32) who underwent transcatheter aortic valve replacement from December 2022 to April 2024. HALT and eccentricity of the implanted TAV were analyzed with 30-day postprocedural computed tomography. HALT was defined as involvement of more than 25% from the leaflet base in at least one leaflet, based on the Valve Academic Research Consortium 3 criteria. Results The overall incidence of HALT was 30.4%, with a significantly higher incidence in Navitor than in Sapien or Evolut (56.2% vs. 22.2% vs. 20.5%, p = 0.001). In all three groups (Sapien, Evolut, and Navitor), eccentricity at the leaflet inflow level was significantly greater in patients with HALT compared to without HALT (median 0.38 [IQR 0.36-0.45] vs. 0.34 [0.29-0.39]; p = 0.040, 0.59 [0.39-0.67] vs 0.36 [0.32-0.41]; p < 0.001, 0.64 [0.57-0.77] vs 0.44 [0.40-0.51]; p < 0.001). Eccentricity at the native annulus level was significantly lower in Sapien compared with Evolut and Navitor (0.36 [0.33-0.42] vs. 0.60 [0.48-0.67] and 0.59 [0.49-0.70], respectively; p < 0.001). Eccentricity at the leaflet inflow level was significantly greater in Navitor compared with Sapien and Evolut (0.36 [0.31-0.39] and 0.36 [0.33-0.44] vs. 0.57 [0.45-0.67], respectively; p < 0.001). Conclusion The self-expandable, intra-annular design is more affected by the device landing zone and results in leaflet level deformation, leading to increased incidence of HALT.
No takes yet. Share an insight, caveat, or question.
Onishi et al. (2026) conducted an observational in Patients undergoing transcatheter aortic valve replacement (TAVR) (n=125). Navitor transcatheter aortic valve vs. Sapien and Evolut transcatheter aortic valves was evaluated on Hypoattenuating leaflet thickening (HALT) (>25% involvement from the leaflet base in at least one leaflet on 30-day CT) (p=0.001). Navitor TAV had a significantly higher 30-day incidence of HALT compared with Sapien and Evolut valves (56.2% vs. 22.2% vs. 20.5%, p = 0.001), associated with greater leaflet inflow eccentricity.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: