title: Incidence, predictors and impact of bleeding after transcatheter aortic valve implantation using the balloon-expandable Edwards prosthesis.
abstract: OBJECTIVE
  To evaluate the incidence, predictors and impact of bleeding after transcatheter aortic valve implantation (TAVI).
  
  
  METHODS
  Single-centre prospective observational study.
  
  
  METHODS
  Charles Nicolle University Hospital, Rouen, France.
  
  
  METHODS
  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.
authors.affiliation: Department of Cardiology, Charles Nicolle University Hospital, INSERM U 1096, 1 rue de Germont, Rouen Cedex 76031, France.
authors.forename: Bogdan
authors.initials: B
authors.lastname: Borz
authors.forename: Eric
authors.initials: E
authors.lastname: Durand
authors.forename: Matthieu
authors.initials: M
authors.lastname: Godin
authors.forename: Christophe
authors.initials: C
authors.lastname: Tron
authors.forename: Alexandre
authors.initials: A
authors.lastname: Canville
authors.forename: Pierre-Yves
authors.initials: PY
authors.lastname: Litzler
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Bessou
authors.forename: Alain
authors.initials: A
authors.lastname: Cribier
authors.forename: Hélène
authors.initials: H
authors.lastname: Eltchaninoff
mesh_terms: D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000401:mortality / Q000601:surgery*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000379:methods*; D005260:Female; D005263:Femoral Artery; D005500:Follow-Up Studies; D005602:France / Q000453:epidemiology; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D015994:Incidence; D008297:Male; D019106:Postoperative Hemorrhage / Q000453:epidemiology* / Q000209:etiology; D011379:Prognosis; D011446:Prospective Studies; D011474:Prosthesis Design; D018570:Risk Assessment / Q000379:methods*; D012307:Risk Factors