Levosimendan increases bleeding risk after heart valve surgery: a retrospective analysis of a randomized trial

J Cardiothorac Vasc Anesth. 2014 Oct;28(5):1238-42. doi: 10.1053/j.jvca.2014.04.022.

Abstract

Objective: To investigate whether levosimendan, an inotrope with cardioprotective properties, increases postoperative bleeding after cardiac surgery.

Design: Retrospective analysis of a randomized, prospective clinical study.

Setting: Post-anesthesia care unit (PACU) and surgical ward in a university hospital.

Participants: Two hundred heart valve surgery patients.

Interventions: 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.

Measurements and main 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.

Keywords: cardiac surgery; cardiac tamponade; heart valve surgery; levosimendan; platelet; postoperative bleeding.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • Cardiopulmonary Bypass / adverse effects*
  • Cardiopulmonary Bypass / trends
  • Cardiotonic Agents / administration & dosage*
  • Cardiotonic Agents / adverse effects*
  • Double-Blind Method
  • Female
  • Humans
  • Hydrazones / administration & dosage*
  • Hydrazones / adverse effects*
  • Infusions, Intravenous
  • Male
  • Middle Aged
  • Postoperative Hemorrhage / chemically induced*
  • Postoperative Hemorrhage / etiology
  • Prospective Studies
  • Pyridazines / administration & dosage*
  • Pyridazines / adverse effects*
  • Retrospective Studies
  • Simendan

Substances

  • Cardiotonic Agents
  • Hydrazones
  • Pyridazines
  • Simendan