Key Points
- To evaluate the incidence, independent predictors, and clinical impact of post-procedural bleeding complications in patients undergoing transcatheter aortic valve implantation.
- Conducted a single-centre prospective observational study of 250 consecutive patients undergoing TAVI between May 2006 and October 2011 in Rouen, France.
- Implanted Edwards SAPIEN and SAPIEN XT valves via transfemoral (TF; n=190, 76%) or transapical (TA) access routes, using surgical cutdown or percutaneous techniques.
- Categorized complications according to Valve Academic Research Consortium criteria and identified risk factors for bleeding and mortality using multivariate analysis.
- Post-TAVI bleeding occurred in 68 patients (27.2%), comprising life-threatening bleeding (LTB) in 33 (13.2%), major bleeding in 23 (9.2%), and minor bleeding in 12 (4.8%).
- Transapical access was the only independent predictor of LTB (OR 3.7, 95% CI 1.73 to 7.9, p = 0.001).
- Patients with LTB had significantly higher 30-day mortality (33.3% vs 3.7%, p < 0.001) and 1-year mortality (54% vs 18%, p < 0.001), with LTB serving as an independent predictor of 1-year mortality (HR 2.54, 95% CI 1.3 to 4.9, p = 0.002).
Structured PICO
PPopulation250 consecutive patients who underwent transcatheter aortic valve implantation (TAVI) between May 2006 and October 2011 at a single center in France.
IInterventionTranscatheter aortic valve implantation (TAVI) using Edwards SAPIEN and SAPIEN XT valves via transfemoral (TF) and transapical (TA) routes
OOutcomeIncidence of bleeding (life-threatening, major, and minor) defined by Valve Academic Research Consortium (VARC) criteria, and its impact on 30-day and 1-year mortalitysafety
Bleeding is a frequent complication after TAVI (27.2%), and life-threatening bleeding, which is strongly predicted by transapical access, significantly increases 1-year mortality.