Durability of balloon-expandable and self-expandable transcatheter aortic valves in patients with a large aortic...

Limited evidence has been available on the long-term prognosis and valve durability of balloon-expandable transcatheter heart valve (BE-THV) and self-expandable transcatheter heart valve (SE-THV) in patients with large aortic annulus (LAA).

To compare the long-term outcomes between the BE-THV and SE-THV.

We retrospectively analyzed 1054 patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) for tricuspid aortic valve stenosis with LAA, defined as an annulus area > 430 mm², using either a BE-THV (SAPIEN 3, Edwards Life Sciences) or SE-THV (Evolut R/PRO, Medtronic). The 7-year cumulative incidences of all-cause mortality and bioprosthetic valve failure (BVF) were evaluated in the overall cohort and the propensity score (PS)-matched cohort.

Among the 1054 patients with LAA, 829 (78.7 %) received a BE-THV. The PS-matched population resulted in 218 pairs. The cumulative incidence of all-cause mortality 7 years after TAVI was comparable between the BE-THV and SE-THV groups in the overall cohort (58.6 % vs. 67.6 %, log-rank P = 0.848) and the PS-matched cohort (53.2 % vs. 69.9 %, log-rank P = 0.173). In the overall cohort, the BE-THV group demonstrated a lower exposure-adjusted BVF rate as compared with the SE-THV, although the difference was not significant (6.1 vs. 9.6 events per 1000 patient-years, P = 0.258). This trend became pronounced after PS matching (3.3 vs. 9.9 events per 1000 patient-years, P = 0.017), which was also confirmed by Gray's test (P = 0.032).

In the current analysis focusing on patients with LAA, the BE-THV and SE-THV groups had a comparable long-term prognosis, but the BE-THV group had a lower BVF rate than did the SE-THV group.

UMIN000020423.