Effect of levosimendan on survival and adverse events after cardiac surgery: a meta-analysis.
OBJECTIVE
Left ventricular systolic dysfunction is associated with increased morbidity and mortality in patients undergoing cardiac surgery. The authors performed a meta-analysis investigating the effects of levosimendan in cardiac surgery patients with and without preoperative systolic dysfunction.


METHODS
Meta-analysis of randomized controlled trials.


METHODS
Hospital.


METHODS
The 1,155 patients who participated in 14 randomized controlled trials of perioperative levosimendan were included.


METHODS
None.


RESULTS
PubMed, EMBASE, the Cochrane database of clinical trials, and conference proceedings were searched for clinical trials of perioperative levosimendan in patients undergoing cardiac surgery through May 1, 2012. Studies were grouped by mean ejection fraction (EF). Those with a mean EF <40% were designated as low-EF. Pooled results demonstrated a reduction in mortality with levosimendan (risk difference [RD]-4.2%; 95% CI -7.2%, -1.1%; p = 0.008). Subgroup analysis showed that this benefit was confined to the low-EF studies (RD -7.0%; 95% CI -11.0%, -3.1%; p < 0.001). No benefit was observed in the preserved-EF subgroup (RD +1.1%; 95% CI -3.8%, +5.9%; p = 0.66). Significant reductions also were seen in the need for dialysis (RD -4.9%; 95% CI -8.2%, -1.6%; p = 0.003), myocardial injury (RD -5.0%; 95% CI -8.3%, -1.7%; p = 0.003), and postoperative atrial fibrillation (RD -8.1%; 95% CI -13.3%, -3.0%; p = 0.002).


CONCLUSIONS
Levosimendan was associated with reduced mortality and other adverse outcomes in patients undergoing cardiac surgery, and these benefits were greatest in patients with reduced EF. These data support the need for adequately powered randomized clinical trials to confirm the benefits of levosimendan in patients with reduced EF undergoing cardiac surgery.
Duke Clinical Research Institute, 2400 Pratt Street, Durham, NC. Electronic address: robert.w.harrison@duke.edu.
Robert W
RW
Harrison
Vic
V
Hasselblad
Rajendra H
RH
Mehta
Ricardo
R
Levin
Robert A
RA
Harrington
John H
JH
Alexander
D006348:Cardiac Surgical Procedures / Q000379:methods* / Q000401:mortality; D002315:Cardiopulmonary Bypass / Q000009:adverse effects / Q000401:mortality; D002316:Cardiotonic Agents / Q000627:therapeutic use*; D003627:Data Interpretation, Statistical; D017052:Hospital Mortality; D006801:Humans; D006835:Hydrazones / Q000627:therapeutic use*; D019990:Perioperative Care; D011183:Postoperative Complications / Q000401:mortality* / Q000517:prevention & control*; D017594:Publication Bias; D011724:Pyridazines / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012044:Regression Analysis; D018570:Risk Assessment; D000077464:Simendan; D013318:Stroke Volume / Q000502:physiology; D013534:Survival; D018487:Ventricular Dysfunction, Left / Q000150:complications
D002316:Cardiotonic Agents; D006835:Hydrazones; D011724:Pyridazines; D000077464:Simendan
cardiopulmonary bypass; heart failure; intensive care; meta-analysis; statistics