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Pre-Dilatation Versus No Pre-Dilatation for Implantation of a Self-Expanding Valve in All Comers Undergoing TAVR: The DIRECT Trial.
- Source :
-
JACC. Cardiovascular interventions [JACC Cardiovasc Interv] 2019 Apr 22; Vol. 12 (8), pp. 767-777. Date of Electronic Publication: 2019 Mar 27. - Publication Year :
- 2019
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Abstract
- Objectives: The aim of this study was to compare the implantation of a self-expanding valve with or without balloon aortic valvuloplasty (BAV) in an open-label, noninferiority, randomized trial.<br />Background: There are no randomized studies comparing the implantation of a self-expanding valve with (pre-BAV) or without BAV.<br />Methods: Consecutive patients with severe aortic stenosis were randomly assigned to undergo transcatheter aortic valve replacement with the use of self-expanding prostheses with (pre-BAV) or without (no-BAV) pre-dilatation. The primary endpoint was device success according to the Valve Academic Research Consortium 2 criteria. Secondary endpoints included periprocedural mortality and stroke, new permanent pacemaker implantation, vascular complications, and 1-year mortality. The trial was scheduled to show noninferiority (Δ = 15%) of the direct versus the pre-BAV approach.<br />Results: A total of 171 patients were randomized at 4 centers. Of these, 86 underwent transcatheter aortic valve replacement with pre-dilatation and 85 without. Device success was noninferior in the no-BAV group compared with the pre-BAV group (65 of 85 [76.5%] for no-BAV vs. 64 of 86 [74.4%] for pre-BAV; mean difference 2.1%; 90% confidence interval: -8.9% to 13%). In the no-BAV group, 25 patients (29.4%) underwent post-balloon dilatation, and in the pre-BAV group, 13 patients (15.1%) underwent post-balloon dilatation (p = 0.03). Regarding major vascular complications and permanent pacemaker implantation, there was no difference between the 2 groups (log-rank p = 0.49, log-rank p = 0.54). In 1-month completed follow-up for all patients, there was 1 periprocedural stroke (0.5%), without any deaths.<br />Conclusions: Direct, without balloon pre-dilatation, transcatheter aortic valve replacement with a self-expanding prosthesis system is noninferior to the pre-dilatation procedure. Lower post-dilatation rates were encountered in the group with pre-dilatation. (The Predilatation in Transcatheter Aortic Valve Implantation Trial [DIRECT]; NCT02448927).<br /> (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Aged
Aged, 80 and over
Aortic Valve diagnostic imaging
Aortic Valve physiopathology
Aortic Valve Stenosis diagnostic imaging
Aortic Valve Stenosis mortality
Aortic Valve Stenosis physiopathology
Female
Greece
Hemodynamics
Humans
Israel
Male
Prospective Studies
Prosthesis Design
Recovery of Function
Risk Factors
Severity of Illness Index
Time Factors
Transcatheter Aortic Valve Replacement adverse effects
Transcatheter Aortic Valve Replacement mortality
Treatment Outcome
Aortic Valve surgery
Aortic Valve Stenosis surgery
Balloon Valvuloplasty adverse effects
Balloon Valvuloplasty mortality
Heart Valve Prosthesis
Transcatheter Aortic Valve Replacement instrumentation
Subjects
Details
- Language :
- English
- ISSN :
- 1876-7605
- Volume :
- 12
- Issue :
- 8
- Database :
- MEDLINE
- Journal :
- JACC. Cardiovascular interventions
- Publication Type :
- Academic Journal
- Accession number :
- 30928442
- Full Text :
- https://doi.org/10.1016/j.jcin.2019.02.005