Levosimendan versus an intra-aortic balloon pump in high-risk cardiac patients.

OBJECTIVE

To test the hypothesis that levosimendan is more effective than intra-aortic balloon pump (IABP) support in cardiac surgical patients with low left ventricular ejection fraction to decrease cardiac troponin I levels (primary endpoint) and improve hemodynamics.

DESIGN

Prospective randomized trial.

SETTING

Tertiary cardiothoracic referral center.

PARTICIPANTS

Ninety patients with coronary artery disease and left ventricular ejection fraction <35% who underwent surgery with cardiopulmonary bypass.

INTERVENTION

Patients were assigned randomly to 1 of 3 groups. Group A received a prophylactic IABP one day before surgery. Group B received a prophylactic IABP one day before surgery and a levosimendan infusion at a dose of 0.1 μg/kg/min with an initial bolus (12 μg/kg for 10 minutes) after anesthesia induction. Group C received a levosimendan infusion at a dose of 0.1 μg/kg/min with an initial bolus (12 μg/kg for 10 minutes) after anesthesia induction. Hemodynamic and biochemical data and rate of complications were analyzed.

MEASUREMENTS AND MAIN RESULTS

The cardiac troponin I level in group C 6 hours after surgery was lower than in group A (p = 0.048). The cardiac index in group A was significantly lower than in groups B and C. The intensive care unit stay was significantly shorter in group C than in groups A and B (p = 0.001). The need for inotropic support, the rate of complications, and mortality among groups did not differ.

CONCLUSIONS

The infusion of levosimendan after anesthesia induction in cardiac surgical patients contributes to lower cardiac troponin I levels and improved hemodynamics compared with a preoperative IABP.