Abstract
Background: Patients with low ejection fraction (EF<25%) present high-risk of mortality and development of low output state (LOS) after cardiac surgery. The objective of this research was to evaluate the preoperative use of the calcium sensitizer Levosimendan (Levo) in patients with EF<25%, underwent open heart surgery. Thirty-day mortality and development of postoperative LOS were the primary end-points of the study. Methods: Patients with EF<25% and hemodynamic parameters of LOS (cardiac index<2.2 L/min/m2 and pulmonary artery occlusion pressure>15 mm Hg), underwent coronary bypass surgery between 12/01/2002 and 02/01/2007 were randomized to: preoperative infusion of Levo 0.1 mcg/Kg/min, 24 hours before surgery (Levo group-preoperative optimization), or placebo (Control group). LOS postoperative was defined for the same hemodynamic variables. A P value < 0.05 was considered significant Results: Two-hundred and twenty one patients fulfilled the inclusion criteria, being randomized 111 of them to Levo, and 110 patients to placebo. Both groups were comparable in their general and surgical characteristics. No withdrawal of Levo was required during the preoperative administration, with 8 patients showing hypotension episodes which was resolved with fluid infusions. There were not ventricular arrhythmias, supraventricular arrhythmias (with heart rate over 125) or preoperative ischemic events. The 30-day mortality was 3 patients in the Levo group (2.7%) versus 12 patients in the Control group (10.9%, P value 0.001, OR 0.23, IC95 0.05– 0.90). Seven patients in the Levo group developed postoperative LOS (6.3%) against 20 patients in the Control group (18.2%, P value <0.001, OR 0.30, IC95 0.11– 0.80) Conclusion: The preoperative optimization with Levosimendan reduced the operative mortality and the development of postoperative LOS in patients with EF<25% underwent open heart surgery. The infusion was safety no needing to withdraw it in any case. These findings could represent a new strategy to reduce the operative risk in this group of patients.:
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