Impact of implantation depth on outcomes of new-generation balloon-expandable transcatheter heart valves.

Little is known about the impact of the ID on outcomes and device success using balloon-expandable devices. This study sought to analyze the impact of implantation depth (ID) on procedural outcomes. In consecutive patients (n = 969) undergoing transfemoral TAVR with new-generation balloon-expandable prostheses, the mean ID (IDMean) was determined by aortography and categorized into low, correct, and high device position. Outcomes of interest were device success (VARC-2), paravalvular regurgitation (PVR) ≥ moderate, severe prosthesis-patient mismatch (PPM), permanent pacemaker implantation (PPI), and the composite of the three latter outcome measures (COMPPPP). IDMean was greater among patients with PPI (median 4.0 [interquartile range 2.0; 4.0] vs. 3.5 [1.5; 5.5] mm; p = 0.002), severe PPM (3.5 [1.5; 5.0] vs. 4.0 [2.0; 6.0] mm; p = 0.028), and COMPPPP (4.0 [2.0; 6.0] vs. 3.0 [1.5; 5.5] mm; p < 0.001) when compared with the respective groups without these complications. There was no significant association between IDMean and device success or PVR ≥ moderate. Categorization into low (7.3%), correct (90.7%), and high (2.0%) device position showed significant discrimination with an increase of severe PPM, PPI, and COMPPPP with lower position, whereas device success was not significantly affected by position. Only PVR ≥ moderate showed an asymmetric distribution with highest rates in the high and low position group, which was non-significant. However, among patients without correct position the rate of device success was 45.6%. A higher device position was associated with improved outcomes. Malpositioning without functional impairment should not be classified as device failure. The odds ratio of IDMean was calculated by univariate logistic regression for each outcome variable, showing that with higher values of IDMean (i.e., low implantation depth), the risk of severe PPM, PPI, and COMPPPP increases. The bar charts under the heading “Position category” denote the frequency of each outcome measure across patients with high, correct, and low device position. The p values are derived from chi-squared test.