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Levosimendan in Patients with Low Cardiac Output Syndrome After Cardiac Surgery: A Substudy of the Multicenter
Vladimir Boboshko1, Vladimir Lomivorotov2, Pavel Ruzankin3
1Department of Anesthesiology and Intensive Care, E. Meshalkin National Medical Research Center, Novosibirsk, Russia.
Insights
Perioperative levosimendan did not improve 5-year survival in patients with low cardiac output syndrome after cardiac surgery. This study found no significant differences in long-term mortality or major clinical outcomes between levosimendan and placebo groups.
Area of Science:
- Cardiology
- Cardiovascular Surgery
- Critical Care Medicine
Background:
- Low cardiac output syndrome (LCOS) is a serious complication after cardiac surgery.
- Hemodynamic support is crucial for managing LCOS.
- Levosimendan is a calcium sensitizer used to improve cardiac function.
Purpose of the Study:
- To evaluate the long-term (5-year) efficacy of levosimendan in patients with LCOS post-cardiac surgery.
- To assess the impact of levosimendan on mortality and other clinical outcomes.
Main Methods:
- A single-center subanalysis of the CHEETAH trial involving 134 adult patients.
- Patients received either levosimendan or placebo in addition to standard care.
- Randomized controlled trial design with a 1:1 allocation ratio.
Main Results:
- No significant difference in 5-year long-term mortality between levosimendan and placebo groups (HR 1.59, p=0.17).
- No significant differences observed in secondary outcomes including acute kidney injury (AKI), ICU stay, hospital stay, and 30-day mortality.
- A statistically significant reduction in mean pulmonary artery pressure was noted in the levosimendan group at 4-6 hours post-randomization.
Conclusions:
- Perioperative levosimendan administration does not improve long-term survival in patients with LCOS after cardiopulmonary bypass (CPB).
- Levosimendan did not demonstrate benefits regarding major clinical outcomes like AKI, ICU/hospital length of stay, or 30-day mortality.
Objective:
To test the hypothesis that levosimendan administration in patients with low cardiac output syndrome after cardiac surgery is associated with improved long-term (5-year follow-up) outcomes.
Design:
Single-center subanalysis of the multicenter randomized CHEETAH trial.
Setting:
Cardiac surgery department of a tertiary hospital.
Participants:
A total of 134 adult patients requiring hemodynamic support for a cardiac index <2.5 L/min/m2 after cardiac surgery with cardiopulmonary bypass (CPB).
Interventions:
Patients were randomized (1:1 ratio) to receive levosimendan (continuous infusion with a starting dose of 0.05 μg/kg/min) or placebo, in addition to standard inotropic care.
Measurements And Main Results:
The primary endpoint was long-term mortality (1-5 years) after randomization. Secondary outcomes were hemodynamic parameters, need for inotropic support, acute kidney injury (AKI), need for renal replacement therapy, duration of mechanical ventilation, intensive care unit (ICU) and hospital stay, and 30-day mortality. No significant between-group difference in long-term mortality (5 years) was observed (hazard ratio, 1.59; 95% confidence interval, 0.81 to 3.11; p = 0.17). There were no significant differences in secondary outcomes, except for the difference in the mean pulmonary artery pressure at 4 to 6 hours after randomization, which was lower in the levosimendan group compared to the placebo group (median, 24 [interquartile range (IQR), 21.8-28] mmHg vs 26 [IQR, 22.2-33] mmHg; p = 0.019).
Conclusions:
Among patients requiring hemodynamic support after cardiac surgery with CPB, perioperative levosimendan infusion did not affect long-term survival (1-5 years) compared with placebo. Levosimendan also had no effect on major clinical outcomes such as AKI, ICU stay, hospital stay, and 30-day mortality.
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