Procedural predictors of Post-TAVR Aortic Regurgitation for Balloon-expendable and Self-expendable devices? Insights from the France 2 registry

Background: A significant peri-valvular aortic regurgitation (AR) is observed in 10-20 after a successful TAVR procedure. The prognostic value and the specific procedural predictors of such complication in Balloon-expendable (BE) and Self-expendable (SE) TAVR 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 302±164 days. Results: Mean age was 83±7 years; 49% were female and logistic EuroSCORE was 21.5±13.8. BE and SE devices was implanted in 67.6% (n=1872) and 32.4% (n=897), respectively. Approaches were femoral (75.4%) or non femoral (24.6%). Post-procedural TTE showed a perivalvular AR ≥2 in 14.9% of cases. Its occurrence was 2 fold higher in SE (19.8%) than in BE-TAVR procedures (12.2%, p=0.0001). This remained significant in multivariate analysis (adjusted HR=2.01, p=0.0001). A perivalvular AR≥2 was associated with a mortality at 1 year (24.2%) twice higher than in patients without AR (11.9%) (p=0.0001). This figure was similar for BE (27.1% vs 12.0%) and SE-TAVR (20.5% vs 11.8%) procedures. By multivariate analysis, a perivalvular AR≥2 was the strongest predictor of 1 year mortality (ad. HR=2.35 [1.75-3.15]; p=0.0001). This figure was similar for BE (ad. HR=2.68) and SE-TAVR (ad. HR=2.10) procedures.For BE-TAVI procedures, a larger aortic annulus (ad. HR=1.09 for 1 mm increase, p=0.001), a smaller device diameter (ad. HR=2.38 for 3 mm decrease, p=0.0001) and a femoral approach (ad. HR=1.70, p=0.006) were the 3 major independent procedural predictors of peri-valvular AR≥2.For SE-TAVI procedures, femoral approach (ad.HR=2.10, p=0.008) was the only independent predictors of AR≥2. Importantly, device diameter andaortic annulus diameter were not a predictor of AR for SE-TAVR procedures. Conclusions: Post-procedural perivalvular AR≥2 was observed in 15% of successful TAVI procedures and was the strongest and independent predictor of 1-year mortality for both BE and SE-TAVR procedures. Analysis of procedural predictors of AR suggests that device type and specific procedural characteristics may impact the occurrence of AR.