title: Usefulness of baseline activated clotting time-guided heparin administration in reducing bleeding events during transfemoral transcatheter aortic valve implantation.
abstract: OBJECTIVE
  This study sought to evaluate the impact of baseline activated clotting time (ACT)-guided heparin administration on major bleeding after transfemoral transcatheter aortic valve implantation (TAVI).
  
  
  BACKGROUND
  Bleeding after TAVI is frequent and associated with unfavorable prognosis. Proper intraprocedural heparin dose administration may reduce the risk of potential overdosing in this frail study group.
  
  
  METHODS
  Of the patients who underwent transfemoral TAVI in our center from November 1, 2007 to June 31, 2012, 362 were retrospectively analyzed. Because abnormally high baseline ACT values were noted, heparin was administered at the operator's discretion, according to baseline ACT (ACT-guided, n = 174) or patient's body weight (non-ACT-guided, n = 188). The primary study objective was 30-day major bleeding as defined by the Valve Academic Research Consortium criteria. Secondary objectives were any life-threatening, and minor bleeding, and other Valve Academic Research Consortium outcomes at 30 days.
  
  
  RESULTS
  Bleeding occurred in 167 (46.1%) patients; of these, 76 (21.0%) had major bleeding. The ACT-guided group had a significantly lower occurrence of major (7.5% vs. 33.5%, p < 0.001), life-threatening (12.1% vs. 20.2%, p = 0.04), and any bleeding (25.9% vs. 64.9%, p < 0.001). Conversely, no differences were noted in the other study objectives. After adjustment for potential confounders, the protective odds ratio for ACT-guided therapy on major bleeding was 6.4 (95% confidence interval: 2.3 to 17.9; p < 0.001) at 30 days.
  
  
  CONCLUSIONS
  In our experience, heparin administration according to baseline ACT was correlated with a significantly lower occurrence of major bleeding in transfemoral TAVI. This strategy might be a useful tool in reducing bleeding in this high-risk study group.
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Bernelli
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy. Electronic address: chieffo.alaide@hsr.it.
authors.forename: Alaide
authors.initials: A
authors.lastname: Chieffo
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Matteo
authors.initials: M
authors.lastname: Montorfano
authors.affiliation: Cardiothoracic Department, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Maisano
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Gennaro
authors.initials: G
authors.lastname: Giustino
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Gill Louise
authors.initials: GL
authors.lastname: Buchanan
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Jaclyn
authors.initials: J
authors.lastname: Chan
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Charis
authors.initials: C
authors.lastname: Costopoulos
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Azeem
authors.initials: A
authors.lastname: Latib
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Filippo
authors.initials: F
authors.lastname: Figini
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Ermelinda
authors.initials: E
authors.lastname: De Meo
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Giannini
authors.affiliation: Cardiothoracic Department, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Remo Daniel
authors.initials: RD
authors.lastname: Covello
authors.affiliation: Cardiothoracic Department, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Gerli
authors.affiliation: Cardiothoracic Department, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Annalisa
authors.initials: A
authors.lastname: Franco
authors.affiliation: Cardiology Department, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Eustachio
authors.initials: E
authors.lastname: Agricola
authors.affiliation: Cardiothoracic Department, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Pietro
authors.initials: P
authors.lastname: Spagnolo
authors.affiliation: Cardiothoracic Department, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Micaela
authors.initials: M
authors.lastname: Cioni
authors.affiliation: Cardiothoracic Department, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Ottavio
authors.initials: O
authors.lastname: Alfieri
authors.affiliation: Cardiology Department, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Paolo Guido
authors.initials: PG
authors.lastname: Camici
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D001024:Aortic Valve Stenosis / Q000097:blood / Q000175:diagnosis / Q000628:therapy*; D001777:Blood Coagulation / Q000187:drug effects*; D001835:Body Weight; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation; D016009:Chi-Square Distribution; D004334:Drug Administration Schedule; D005260:Female; D005263:Femoral Artery; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D006470:Hemorrhage / Q000139:chemically induced / Q000517:prevention & control*; D006493:Heparin / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D016015:Logistic Models; D008297:Male; D015999:Multivariate Analysis; D016017:Odds Ratio; D011237:Predictive Value of Tests; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014914:Whole Blood Coagulation Time
chemical_list: D000925:Anticoagulants; D006493:Heparin
keywords: activated clotting time; aortic stenosis; bleeding; transcatheter aortic valve implantation