title: Levosimendan increases bleeding risk after heart valve surgery: a retrospective analysis of a randomized trial.
abstract: OBJECTIVE
  To investigate whether levosimendan, an inotrope with cardioprotective properties, increases postoperative bleeding after cardiac surgery.
  
  
  METHODS
  Retrospective analysis of a randomized, prospective clinical study.
  
  
  METHODS
  Post-anesthesia care unit (PACU) and surgical ward in a university hospital.
  
  
  METHODS
  Two hundred heart valve surgery patients.
  
  
  METHODS
  The patients were randomized to receive either a 24-hour intravenous infusion of levosimendan or placebo. Infusion was administered as a 24 µg/kg bolus over 30 minutes and then continued at a dose of 0.2 µg/kg/min.
  
  
  RESULTS
  Postoperative bleeding was approximately 31% greater in the levosimendan group (1050 mL) compared to the placebo group (880 mL, p = 0.008). Serious bleeding exceeding 1000 mL was more common in the levosimendan group than the placebo group (51 v 38 patients, p = 0.044, risk ratio (RR) 1.37, 95% CI 1.00-1.87). However, the risk of reoperation for bleeding did not increase if patients received levosimendan (RR 1.52, 95% CI 0.77-2.97, p = 0.309). This result did not change after excluding patients who received clopidogrel preoperatively (RR 2.13, 95% CI 0.98-4.65, p = 0.145). The groups did not differ regarding transfused blood products. Eight patients, including seven from the levosimendan group, had delayed (diagnosed>48 hours after the surgery) cardiac tamponade and underwent re-exploration (7 v 1, p = 0.031).
  
  
  CONCLUSIONS
  Levosimendan increased the risk of postoperative bleeding after cardiac valve surgery. In addition, the risk of postoperative cardiac tamponade was increased in patients who received levosimendan compared to placebo.
authors.affiliation: Department of Anesthesiology, Kuopio University Hospital, Kuopio, Finland. Electronic address: pasi.lahtinen@kuh.fi.
authors.forename: Pasi
authors.initials: P
authors.lastname: Lahtinen
authors.affiliation: Department of Anesthesiology, Kuopio University Hospital, Kuopio, Finland.
authors.forename: Otto
authors.initials: O
authors.lastname: Pitkänen
authors.affiliation: Department of Anesthesiology, Kuopio University Hospital, Kuopio, Finland.
authors.forename: Tadeusz
authors.initials: T
authors.lastname: Musialowicz
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002315:Cardiopulmonary Bypass / Q000009:adverse effects* / Q000639:trends; D002316:Cardiotonic Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006835:Hydrazones / Q000008:administration & dosage* / Q000009:adverse effects*; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D019106:Postoperative Hemorrhage / Q000139:chemically induced* / Q000209:etiology; D011446:Prospective Studies; D011724:Pyridazines / Q000008:administration & dosage* / Q000009:adverse effects*; D012189:Retrospective Studies; D000077464:Simendan
chemical_list: D002316:Cardiotonic Agents; D006835:Hydrazones; D011724:Pyridazines; D000077464:Simendan
keywords: cardiac surgery; cardiac tamponade; heart valve surgery; levosimendan; platelet; postoperative bleeding