Author + information
- Received October 15, 2019
- Revision received November 6, 2019
- Accepted December 3, 2019
- Published online March 2, 2020.
- Florence Leclercq, MD, PhDa,∗ (, )
- Pierre Robert, MDa,
- Mariama Akodad, MD, PhDa,b,
- Jean-Christophe Macia, MDa,
- Thomas Gandet, MDc,
- Delphine Delseny, MDa,
- Marine Chettouh, MSca,
- Laurent Schmutz, MDd,
- Gabriel Robert, MDe,
- Gilles Levy, MDf,
- Frederic Targosz, MDg,
- Eric Maupas, MDh,
- Francois Roubille, MD, PhDa,b,
- Gregory Marin, PhDi,
- Nicolas Nagot, MD, PhDi,
- Bernard Albat, MD, PhDc,
- Benoit Lattuca, MD, PhDd and
- Guillaume Cayla, MD, PhDd
- aDepartment of Cardiology, CHU Montpellier, Montpellier University, Montpellier, France
- bPhyMedExp, INSERM U1046, CNRS UMR 9214, Montpellier, France
- cDepartment of Cardiovascular Surgery, University Hospital of Montpellier, France
- dDepartment of Cardiology, CHU Nimes, Montpellier University, Nimes, France
- eSt. Pierre Clinic, Perpignan, France
- fMillenaire Clinic, Montpellier, France
- gPerpignan Hospital, Perpignan, France
- hFranciscaines Clinic, Nimes, France
- iDepartment of Medical Information, University Hospital of Montpellier, Montpellier, France
- ↵∗Address for correspondence:
Prof. Florence Leclercq, Department of Cardiology, Arnaud de Villeneuve Hospital, University of Montpellier, Avenue du doyen Giraud, 34295 Montpellier Cedex 5, France.
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)
- balloon aortic valvuloplasty
- device success
- direct implantation
- randomized clinical trial
- transcatheter aortic valve replacement
This study was funded by the University Hospital of Montpellier through an unrestricted grant from Edwards Lifesciences. Dr. Leclercq has received research grants from Edwards Lifesciences, Medtronic, Boehringer Ingelheim; has received consulting fees from Boehringer Ingelheim; and has received lecture fees from AstraZeneca and Bayer. Dr. Lattuca has received research grants from the ACTION Study Group, Biotronik, Boston Scientific, Daiichi-Sankyo, Fédération Française de Cardiologie, and the Institute of CardioMetabolism and Nutrition; has received consulting fees from Daiichi-Sankyo and Eli Lilly; and has received lecture fees from AstraZeneca and Novartis. Dr. Cayla has received research grants, consulting fees, and lecture fees from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Boston, Biotronik, Bristol-Myers Squibb, Daiichi-Sankyo, Eli Lilly, Europa, Fédération Française de Cardiologie, Fondation Cœur & Recherche, Medtronic, Merck Sharp & Dohme, Pfizer, and Sanofi. Dr. Akodad has received research grants from Edwards Lifesciences and Medtronic. Dr. Robert has received research grants from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received October 15, 2019.
- Revision received November 6, 2019.
- Accepted December 3, 2019.
- 2020 American College of Cardiology Foundation
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