Incidence, predictors and impact of bleeding after transcatheter aortic valve implantation using the balloon-expandable Edwards prosthesis

Objectives To evaluate the incidence, predictors and impact of bleeding after transcatheter aortic valve implantation (TAVI). Design Single-centre prospective observational study. Setting Charles Nicolle University Hospital, Rouen, France. Interventions We included 250 consecutive patients who underwent TAVI between May 2006 and October 2011. All procedures were performed using Edwards SAPIEN and SAPIEN XT valves via transfemoral (TF) and transapical (TA) routes. Surgical cutdown was used for TF access when implanting the SAPIEN valve, while percutaneous access was used for SAPIEN XT implantation. Life-threatening bleeding (LTB), major and minor bleeding and other complications were defined using Valve Academic Research Consortium criteria. Results TAVI was performed via TF access in 190 cases (76%) and the SAPIEN XT valve was used in 123 cases (49.2%). Bleeding after TAVI was noted in 68 patients (27.2%): LTB in 33 (13.2%), major bleeding in 23 (9.2%) and minor bleeding in 12 (4.8%). By multivariate analysis, only TA access was an independent predictor of LTB (OR 3.7, 95% CI 1.73 to 7.9, p=0.001). Patients presenting with LTB after TAVI had a higher 30-day mortality (33.3% vs 3.7%, p<0.001) and 1-year mortality (54% vs 18%, p<0.001). LTB was an independent predictive factor of 1-year mortality (HR 2.54, 95% CI 1.3 to 4.9, p=0.002). Conclusions Bleeding is a frequent complication of TAVI, occurring in 27% of cases. LTB is associated with higher 30-day and 1-year mortality.