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Heart 99:860-865 doi:10.1136/heartjnl-2012-303095
  • Valvular heart disease
  • Original article

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

  1. Hélène Eltchaninoff1
  1. 1Department of Cardiology, Charles Nicolle University Hospital, INSERM U 1096, Rouen, France
  2. 2Department of Heart Surgery, Charles Nicolle University Hospital, INSERM U 1096, Rouen, France
  1. Correspondence to Professor Hélène Eltchaninoff, Department of Cardiology, Charles Nicolle Hospital, University of Rouen, INSERM U 1096, 1 rue de Germont, Rouen Cedex 76031, France; helene.eltchaninoff{at}chu-rouen.fr
  • Received 24 September 2012
  • Revised 19 November 2012
  • Accepted 19 November 2012
  • Published Online First 12 December 2012

Abstract

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.