complication in Balloon-expendable (BE) and Self-expendable (SE) TAVI procedures remain unclear. Methods: 2,769 patients consecutive with a successful procedure and a predischarge transthoracic echocardiography (TTE) were enrolled in 33 centers. Mean follow-up was 302Ϯ164 days. Results: Mean age was 83Ϯ7 years; 49% were female and logistic EuroSCORE was 21.5Ϯ13.8. BE and SE devices was implanted in 67.6% (nϭ1872) and 32.4% (nϭ897), respectively. Approaches were femoral (75.4%) or non femoral: subclavian (5.6%), transapical (17.2%) or transaortic (1.8%). A perivalvular ARՆ2 was observed in 14.9%. Its occurrence was 2 fold higher in SE (19.8%) than in BE-TAVI procedures (12.2%, pϭ0.0001). This remained significant in multivariate analysis (adjusted HRϭ2.01, pϭ0.0001). A perivalvular ARՆ2 was associated with a mortality at 1 year (24.2%) twice higher than in patients without AR (11.9%) (pϭ0.0001). This figure was similar for BE (27.1% vs 12.0%) and SE-TAVI (20.5% vs 11.8%) procedures. By multivariate analysis, a perivalvular ARՆ2 was the strongest predictor of 1 year mortality (ad. ]; pϭ0.0001). This figure was similar for BE (ad. HRϭ2.68) and SE-TAVI (ad. HRϭ2.10) procedures. For BE-TAVI procedures, male gender (ad. HRϭ1.66, pϭ0.001), a device diameter/aortic annulus diameter Ratio Ͻ1.1 (ad. HRϭ1.83, pϭ0.0001) and a femoral approach (ad. HRϭ1.70, pϭ0.006) were the 3 major independent predictors of ARՆ2. For SE-TAVI procedures, male gender (ad. HRϭ1.61, pϭ0.01) and a femoral approach (ad.HRϭ2.1, pϭ0.008) were 2 independent predictors of ARՆ2. Importantly, device diameter/aortic annulus diameter Ratio was not a predictor of AR for SE-TAVI procedures. Conclusions: Post-procedural perivalvular ARՆ2 was observed in 15% of successful TAVI procedures. Its occurrence doubled the 1-year mortality rate and was the strongest and independent predictor of 1-year mortality for both BE and SE-TAVI procedures. Analysis of predictors of AR suggests that device-type and procedural characteristics may impact the occurrence of AR.
Background:The presence of mitral regurgitation (MR) is an independent predictor of mortality after conventional aortic valve replacement for aortic stenosis. The predictive value of pre-procedural MR on clinical outcome after TAVI is unknown. Methods: 3,195 consecutive patients were enrolled in 33 centres. MR was graded according to pre-procedural transthoracic echocardiography (TTE) as none/trivial(ϭ0), mild(ϭ1), moderate(ϭ2), moderate-to-severe(ϭ3), or severe(ϭ4). The mean age was 82Ϯ7 years; 49% were female and mean logistic EuroSCORE was 21.9Ϯ14.3. Balloon (BE) and self-expendable (SE) devices were implanted in 66.9% and 33.1% of patients, respectively. Approaches were transarterial (transfemoral: 74.6%; subclavian: 5.8%), transapical (17.8%), and transaortic (1.8%). Results: Pre-procedural TTE showed no MR in 32% of cases, a grade 1 MR in 46% of cases, a grade 2 MR in 20% of cases and a grade 3-4 in 2% of cases. Procedural success rate was 96.9%. Actuarial 1 year mortality was 19.5%. By univariate anal...