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Levosimendan reduces heart failure after cardiac surgery: A prospective, randomized, placebo-controlled trial*

Lahtinen, Pasi MD; Pitkänen, Otto MD, PhD; Pölönen, Pekka MD; Turpeinen, Anu MD, PhD; Kiviniemi, Vesa Lic. Stat; Uusaro, Ari MD, PhD

doi: 10.1097/CCM.0b013e3182227b97
Clinical Investigations

Objective: To investigate whether levosimendan diminishes the incidence of heart failure after cardiac surgery.

Design: Prospective, randomized, placebo-controlled clinical study.

Setting: Cardiac surgery operating room and postanesthesia care unit in a university hospital.

Patients: Two hundred patients assigned to undergo heart valve or combined heart valve and coronary artery bypass grafting surgery.

Interventions: Patients were randomized to receive a 24-hr infusion of placebo or levosimendan administered as a 24 μg/kg bolus over 30-mins and thereafter at a dose of 0.2 μg/kg/min.

Measurements and Main Results: Heart failure was defined as cardiac index <2.0 L/min/m2 or failure to wean from cardiopulmonary bypass necessitating inotrope administration for at least 2 hrs postoperatively. Heart failure was less frequent in the levosimendan compared to the placebo group: 15 patients (15%) in the levosimendan and 59 patients (58%) in the placebo group experienced heart failure postoperatively (risk ratio 0.26; 95% confidence interval 0.16–0.43; p < .001). Accordingly, a rescue inotrope (adrenaline) was needed less frequently in the levosimendan compared to the placebo group (risk ratio 0.11; 95% confidence interval 0.01–0.89), p = .005. Intra-aortic balloon pump was utilized in one patient (1%) in the levosimendan and in nine patients (9%) in the placebo group (risk ratio 0.11; 95% confidence interval 0.01–0.87), p = .018. The hospital and the 6-month mortality were comparable between groups. There were no significant differences in major organ failures postoperatively. Eighty-three patients were hypotensive and needed noradrenaline in the levosimendan compared to 52 patients in the placebo group, p < .001. The cardiac enzymes (creatine kinase MB isoenzyme mass) indicating myocardial damage were lower in the levosimendan group on the first postoperative day, p = .011.

Conclusions: In the present study, levosimendan infusion reduced the incidence of heart failure in cardiac surgery patients but was associated with arterial hypotension and increased requirement of vasopressor agents postoperatively. Improved mortality or morbidity was not demonstrated.

From the Departments of Anesthesiology and Intensive Care (PL, OP, PP, AU), and Internal Medicine (AT), Kuopio University Hospital, Kuopio, Finland; and IT-Centre (VK), University of Kuopio, Kuopio, Finland.

Supported, in part, by a restricted research grant from Orion Pharma, Espoo, Finland, and a research grant from Kuopio University hospital, Kuopio, Finland.

Drs. Lahtinen and Pitkänen received honoraria from Orion Pharma. The remaining authors have not disclosed any potential conflicts of interest.

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© 2011 by the Society of Critical Care Medicine and Lippincott Williams & Wilkins