title: Factor V Leiden does not affect bleeding in aprotinin recipients after cardiopulmonary bypass.
abstract: BACKGROUND
  Carriers of the factor V Leiden mutation (FVL) are resistant to activated protein C proteolysis. Therefore, they are at increased risk of thromboembolic events. Aprotinin is an unspecific proteinase inhibitor frequently used during cardiac surgery procedures to reduce bleeding. However, aprotinin may cause thromboembolic complications after cardiopulmonary bypass (CPB). The primary endpoint of this study was the amount of blood loss after CPB in aprotinin recipients, and secondary endpoints were thromboembolic complications.
  
  
  METHODS
  A total of 1,447 consecutive patients who underwent cardiac surgery with CPB were prospectively enrolled. All patients were screened for FVL by a fluorescence-based polymerase chain reaction method. Linear and logistic regression analyses were performed to assess associations of FVL on bleeding and thromboembolic complications.
  
  
  RESULTS
  One hundred seven individuals (7.4%) were heterozygous FVL carriers. No difference was found between FVL carriers and noncarriers regarding age, sex, CPB, type of operation, EuroSCORE, antiplatelet treatment, and reoperation. FVL was not significantly associated with postoperative blood loss, whereas a significant influence was found for female sex (P < 0.0001), duration of CPB (P < 0.0001), reoperation (P = 0.001), and preoperative antiplatelet treatment (P < 0.002). Multiple linear regression analysis for total blood loss had an observed power of at least 99%. FVL carriers faced the same risk for postoperative transfusion (P = 0.391), reoperation (P = 0.675), myocardial infarction (P = 0.44), stroke (P = 0.701), and 30-day mortality (P = 0.4) as did noncarriers.
  
  
  CONCLUSIONS
  These data suggest that FVL carriers do not have reduced blood loss compared with noncarriers. Furthermore, the combination of aprotinin and FVL does not enhance the risk for thromboembolic complications.
authors.affiliation: Department of Cardiovascular Surgery, German Heart Center Munich, Technische Universitaet Muenchen, Munich, Germany. johannesfboehm@gmx.net
authors.forename: Johannes
authors.initials: J
authors.lastname: Boehm
authors.forename: Joachim Burkhard
authors.initials: JB
authors.lastname: Grammer
authors.forename: Fabian
authors.initials: F
authors.lastname: Lehnert
authors.forename: Wulf
authors.initials: W
authors.lastname: Dietrich
authors.forename: Stefan
authors.initials: S
authors.lastname: Wagenpfeil
authors.forename: Stephen Michael
authors.initials: SM
authors.lastname: Wildhirt
authors.forename: Michael
authors.initials: M
authors.lastname: Wottke
authors.forename: Siegmund
authors.initials: S
authors.lastname: Braun
authors.forename: Rüdiger
authors.initials: R
authors.lastname: Lange
authors.forename: Robert
authors.initials: R
authors.lastname: Bauernschmitt
mesh_terms: D000328:Adult; D000368:Aged; D007611:Aprotinin / Q000627:therapeutic use*; D002315:Cardiopulmonary Bypass / Q000009:adverse effects*; D003404:Creatinine / Q000097:blood; D005165:Factor V / Q000235:genetics*; D005260:Female; D006490:Hemostatics / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000209:etiology; D019106:Postoperative Hemorrhage / Q000517:prevention & control*; D011446:Prospective Studies; D012044:Regression Analysis
chemical_list: D006490:Hemostatics; C095381:factor V Leiden; D005165:Factor V; D007611:Aprotinin; D003404:Creatinine