Abstract 19787: Transcatheter Aortic Valve Implantation in Patients With Bicuspid Aortic Valve: a Patient Level Multi-center Analysis
Objective: The purpose of the study was to determine the safety and efficacy of TAVI in patients with stenotic bicuspid aortic valve (BAV).
Background: To date, patients with BAV have been excluded from major TAVI studies due to a theoretical increased risk of paravalvular leak (PVL). Data on the clinical performance of TAVI in these patients is limited.
Methodology: We conducted a retrospective international multicenter cohort study of patients with BAV undergoing TAVI. The primary outcome of the study was the combined early safety endpoint - a composite of 30 day mortality, stroke, life-threatening bleeding, acute kidney injury, coronary artery obstruction, major vascular complication and valve related dysfunction. Secondary endpoints included the individual components of the primary endpoint as well as post TAVI paravalvular leak (PVL), rehospitalization, new pacemaker insertion and device success rates at 30 days and 1 year.
Results: A total of 107 patients with BAV were identified in 21 centers in Canada, Spain, Italy, Poland and Singapore who underwent TAVI between January 2005 and March 2014. The composite primary outcome occurred in one third of patients (28.6%) - mainly driven by re-intervention for valve malposition (12.3%). The 30-day and 1 year mortality rate was 9.7% and 17.2% respectively with AR ≥ 3+ occurring in 8.8% of patients. Device success was achieved in 85% of cases with pacemaker insertion in 17.9%. While PVL was not associated with an increased risk of 30 day or 1 year mortality - Type I
BAV anatomy with left and right cusp fusion had significantly better outcomes than other variants.
Conclusion: In selected patients with BAV and severe aortic stenosis TAVI appears both safe and feasible with acceptable clinical outcomes. A randomized comparison of TAVI versus surgical aortic valve replacement in this patient population is warranted.
Author Disclosures: A. Yousef: None. T. Simard: None. J. Webb: None. J. Rodés-Cabau: None. C. Costopoulos: None. J. Kochman: None. J. Hernández-Garcia: None. P.T. Chiam: None. R. Welsh: None. H. Wijeysundera: None. E. García: None. H. Ribeiro: None. A. Latib: None. Z. Huczek: None. M. Shanks: None. L. Testa: None. M. Farkouh: None. D. Dvir: None. J. Velianou: None. B. Lam: None. A. Pourdjabbar: None. C. Glover: None. B. Hibbert: None. M. Labinaz: None.
- © 2014 by American Heart Association, Inc.