Key result
Prophylactic administration of Levosimendan did not significantly reduce 30-day mortality (16% vs 21%; OR 0.7) compared to control in high-risk patients with severely reduced left-ventricular ejection fraction undergoing cardiac surgery.
Why the study?
Does prophylactic levosimendan improve 30-day survival in high-risk patients with severely reduced LVEF undergoing cardiac surgery?
Cohort (n=246)
No
Does prophylactic levosimendan improve 30-day survival in high-risk patients with severely reduced LVEF undergoing cardiac surgery?
Odds Ratio: 0.7 (95% CI 0.36–1.5)
Absolute Event Rate: 16% vs 21%
p-value: p=0.37
Prophylactic administration of levosimendan in high-risk patients with severely reduced LVEF undergoing cardiac surgery did not significantly improve 30-day or long-term survival, but was associated with a reduced incidence of acute kidney injury and a significantly increased risk of postoperative atrial fibrillation.
No support for prophylactic levosimendan to reduce mortality; leaves open effects on AKI or AF in high-risk low-LVEF surgery.
BACKGROUND: Patients with severely reduced left-ventricular ejection fraction carry a high risk of morbidity and mortality after cardiac surgery. Levosimendan can be used prophylactically in these patients having shown positive effects on short-term outcome. However, effects on long-term outcome and patient subgroups benefiting the most are unknown. We aim to address these topics with real-life data from our clinical practice. METHODS: Two hundred eigthy eight patients with preoperative LVEF ≤ 35% underwent cardiac surgery with cardiopulmonary bypass between 2009 and 2013. Thereof, 246 were included in the matched analysis. Eigthy two patients received 12.5mg Levosimendan starting at induction of anesthesia. Outcomes of patients undergoing coronary artery bypass grafting surgery (n = 103), isolated valve surgery/ascending aortic surgery (n = 45) and those undergoing combination procedures (n = 98) were analyzed separately. Additionally, multivariate regression analysis was conducted in order to identify predictors of short-term outcome parameters for different subgroups of patients. RESULTS: Thirty days mortality rates of 16% in the Levosimendan group and 21% in the control group (OR 0.7; 95%-CI 0.36-1.5; p = 0.37) were observed. Levosimendan showed a positive effect on postoperative renal function. A higher rate of new-onset atrial fibrillation (OR 4.0; 95%-CI 2.2-7-2; p < 0.0001) was observed in the Levosimendan group. Follow-up until three years postoperatively showed no differences in long-term survival between the groups. CONCLUSION: Prophylactic administration of Levosimendan did not affect overall short- and long-term outcomes. The value of prophylactic use of Levosimendan remains questionable and more data is needed to confirm subgroups that might benefit most.
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Grieshaber et al. (2016) conducted a cohort in Severely reduced left-ventricular ejection fraction (≤35%) undergoing cardiac surgery (n=246). Levosimendan vs. No Levosimendan (Control) was evaluated on 30-day mortality (OR 0.7, 95% CI 0.36-1.5, p=0.37). Prophylactic administration of Levosimendan did not significantly reduce 30-day mortality (16% vs 21%; OR 0.7) compared to control in high-risk patients with severely reduced left-ventricular ejection fraction undergoing cardiac surgery.
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