Post-Procedural Aortic Regurgitation in Balloon-expandable and Self-Expandable TAVR Procedures: Analysis of Predictors and Impact on Long-Term Mortality: Insights from the FRANCE2 Registry
Background—Significant post-procedural-aortic-regurgitation (AR) is observed in 10-20% of cases after TAVR. The prognostic value and the predictors of such a complication in balloon-expandable (BE) and self-expandable (SE) TAVR remain unclear.
Methods and Results—TAVR was performed in 3,195 consecutive patients at 34 hospitals. Post-procedural-transthoracic echocardiography (TTE) was performed in 2,769 (92%) of the eligible population and constituted the study group. Median follow-up was 306 days (Q1-Q3=178-490). BE and SE devices were implanted in 67.6% (n=1872) and 32.4% (n=897). Delivery was femoral (75.3%) or non-femoral (24.7%). A post-procedural-AR≥Grade2 was observed in 15.8% and was more frequent in SE (21.5%) than in BE-TAVR (13.0%,p=0.0001). Extensive multivariable analysis confirmed that use of a SE device was one of the most powerful independent predictor of post-procedural-AR≥Grade2. For BE-TAVR, 8 independent predictors of post-procedural-AR≥Grade2 were identified including femoral delivery (p=0.04), larger aortic annulus (p=0.0004) and smaller prosthesis diameter (p=0.0001). For SE-TAVR, two independent predictors were identified including femoral delivery (p=0.0001). Aortic annulus and prosthesis diameter were not predictors of post-procedural-AR for SE-TAVR. A post-procedural-AR≥Grade2, but not a post-procedural-AR=Grade1, was a strong independent predictor of one-year mortality for BE (HR=2.50;p=0.0001) and SE-TAVR (HR=2.11;p=0.0001). While Post-procedural-AR≥Grade2 was well tolerated in patients with AR≥Grade2 at baseline (one-year mortality=7%), it was associated with a very high mortality in other subgroups: renal failure (43%), AR<Grade2 at baseline (31%), low trans-aortic gradient (35%) or non-femoral delivery (45%).
Conclusions—Post-procedural-AR≥Grade2 was observed in 15.8% of successful TAVR and was the strongest independent predictor of one-year mortality. The use of the SE device was a powerful independent predictor of post-procedural-AR≥Grade2.
- aortic valve stenosis
- transcutaneous aortic valve implantation
- aortic valve regurgitation
- Received March 28, 2013.
- Revision received January 3, 2014.
- Accepted January 7, 2014.