Department of cardiology, Nimes University Hospital, Nimes, France.
Ramsay Générale de Santé, Institut Cardiovasculaire Paris Sud, Massy, France.
Catheter Cardiovasc Interv. 2024 Jul;104(1):97-104. doi: 10.1002/ccd.31086. Epub 2024 May 19.
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.
We assessed the impact of BAV on the procedural success rate and clinical outcomes in the female population of the DIRECTAVI trial.
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.
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).
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.
随机 DIRECTAVI 试验证明了使用 SAPIEN 3 球囊扩张装置进行经导管主动脉瓣植入术（TAVI）而不进行球囊主动脉瓣成形术（BAV）的安全性和可行性。然而，解剖结构较小的女性人群可能存在残余梯度和/或不匹配的潜在更高风险。
我们评估 BAV 对 DIRECTAVI 试验女性人群中手术成功率和临床结果的影响。
在 2016 年 5 月至 2018 年 5 月期间，DIRECTAVI 试验中纳入的 250 例患者中有 91 例为女性（38.6%），其中 45 例（49.5%）纳入 BAV 组，46 例（50.5%）纳入直接 TAVI 组。主要终点为女性的手术成功率（根据 Valve Academic Research Consortium-2 标准）。次要终点包括评估女性的 PPM 和 1 个月主要不良事件，并根据植入策略比较女性和男性之间的主要终点。
BAV 组有 29 名女性（64.4%）和直接 TAVI 组有 34 名女性（73.9%）达到主要终点（直接策略组的平均差异为 9.47%；95%置信区间：6.5%-25.4%；p=0.045 表示非劣效性）。两组女性 1 个月主要不良事件相似。由于女性中度不匹配发生率较高（p=0.001），女性手术成功率低于男性（p=0.01），但植入策略无显著差异（p=0.4）。
在女性中，直接植入球囊扩张的 SAPIEN 3 瓣膜在手术成功率方面不劣于预扩张。女性中度不匹配的发生率较高，但与植入策略无关。
