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Prior Balloon Valvuloplasty Versus Direct Transcatheter Aortic Valve Replacement

Abstract : Objectives: The aim of this study was to evaluate device success of transcatheter aortic valve replacement (TAVR) using new-generation balloon-expandable prostheses with or without balloon aortic valvuloplasty (BAV). Background: Randomized studies are lacking comparing TAVR without BAV against the conventional technique of TAVR with BAV. Methods: DIRECTAVI (Direct Transcatheter Aortic Valve Implantation) was an open-label noninferiority study that randomized patients undergoing TAVR using the Edwards SAPIEN 3 valve with or without prior balloon valvuloplasty. The primary endpoint was the device success rate according to Valve Academic Research Consortium-2 criteria, which was evaluated using a 7% noninferiority margin. The secondary endpoint included procedural and 30-day adverse events. Results: Device success was recorded for 184 of 236 included patients (78.0%). The rate of device success in the direct implantation group (n = 97 [80.2%]) was noninferior to that in the BAV group (n = 87 [75.7%]) (mean difference 4.5%; 95% confidence interval: −4.4% to 13.4%; p = 0.02 for noninferiority). No severe prosthesis-patient mismatch or severe aortic regurgitation occurred in any group. In the direct implantation group, 7 patients (5.8%) required BAV to cross the valve. Adverse events were related mainly to pacemaker implantation (20.9% in the BAV group vs. 19.0% in the direct implantation group; p = 0.70). No significant difference was found between the 2 strategies in duration of procedure, contrast volume, radiation exposure, or rate of post-dilatation. Conclusions: Direct TAVR without prior BAV was noninferior to the conventional strategy using BAV with new-generation balloon-expandable valves, but without procedural simplification. BAV was needed to cross the valve in a few patients, suggesting a need for upstream selection on the basis of patient anatomy. (TAVI Without Balloon Predilatation [of the Aortic Valve] SAPIEN 3 [DIRECTAVI]; NCT02729519)
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Submitted on : Tuesday, August 3, 2021 - 5:34:45 PM
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2020 Leclercq et al., Prior ba...
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Florence Leclercq, Pierre Robert, Mariama Akodad, Jean-Christophe Macia, Thomas Gandet, et al.. Prior Balloon Valvuloplasty Versus Direct Transcatheter Aortic Valve Replacement. JACC: Cardiovascular Interventions, Elsevier/American College of Cardiology, 2020, 13 (5), pp.594-602. ⟨10.1016/j.jcin.2019.12.006⟩. ⟨hal-02501578⟩



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