Balloon predilation or direct valve implantation in TAVI for women: Insights from the DIRECTAVI study.

Autor: Robert P; Department of cardiology, Nimes University Hospital, Nimes, France., Akodad M; Ramsay Générale de Santé, Institut Cardiovasculaire Paris Sud, Massy, France., Lattuca B; Department of cardiology, Nimes University Hospital, Nimes, France., Gandet T; Department of Cardiovascular Surgery, Montpellier University Hospital, Montpellier, France., Meunier PA; Department of Cardiology, Montpellier University Hospital, Montpellier, France., Macia JC; Department of Cardiology, Montpellier University Hospital, Montpellier, France., Schmutz L; Department of cardiology, Nimes University Hospital, Nimes, France., Steinecker M; Department of Cardiology, Montpellier University Hospital, Montpellier, France., Roubille F; Department of Cardiology, Montpellier University Hospital, Montpellier, France., Cayla G; Department of cardiology, Nimes University Hospital, Nimes, France., Leclercq F; Department of Cardiology, Montpellier University Hospital, Montpellier, France.
Jazyk: angličtina
Zdroj: Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions [Catheter Cardiovasc Interv] 2024 Jul; Vol. 104 (1), pp. 97-104. Date of Electronic Publication: 2024 May 19.
DOI: 10.1002/ccd.31086
Abstrakt: 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.
(© 2024 The Author(s). Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)
Databáze: MEDLINE
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