Abstract
Background The randomized DIRECTAVI trial demonstrated safety and feasibility of transcatheter aortic valve implantation (TAVI) without balloon aortic valvuloplasty (BAV) using SAPIEN 3 balloon‐expandable devices. However, the female population with smaller anatomy may have potential higher risk of residual gradient and/or mismatch. Purpose We assessed the impact of BAV on the procedural success rate and clinical outcomes in the female population of the DIRECTAVI trial. Methods Between May 2016 and May 2018, 91 of the 250 patients included in the DIRECTAVI trial were women (38.6%), 45 of them (49.5%) were enrolled in the BAV group and 46 of them (50.5%) in the direct TAVI group. The primary endpoint was procedural success rate in women (Valve Academic Research Consortium‐2 criteria). The secondary endpoint included evaluation of PPM and 1‐month major adverse events according to the implantation stategy in women and comparison between men and women regarding major endpoints. Results The primary endpoint occurred in 29 women (64.4%) in the BAV group and in 34 women (73.9%) in the direct TAVI group (mean difference 9.47%; 95% confidence interval: 6.5%–25.4%; p = 0.045 for non‐inferiority of the direct strategy). One‐month major adverse events were similar between the 2 women groups. Procedural success was lower in women vs men ( p = 0.01) due to higher incidence of moderate mismatches in women ( p = 0.001) but with no significant difference regarding the implantation strategy ( p = 0.4). Conclusion Direct implantation of the balloon‐expandable SAPIEN 3 valve was non‐inferior to predilatation on procedural success in women. Incidence of moderate mismatch was higher in women but was not related to the implantation strategy.