Abstract
BackgroundPrevious studies have shown beneficial effects of levosimendan in high-risk patients undergoing cardiac surgery. Two large randomized controlled trials (RCTs), however, showed no advantages of levosimendan.MethodsWe performed a systematic review and meta-analysis (MEDLINE and Embase from inception until March 30, 2017), investigating whether levosimendan offers advantages compared with placebo in high-risk cardiac surgery patients, as defined by preoperative left ventricular ejection fraction (LVEF) ≤ 35% and/or low cardiac output syndrome (LCOS). The primary outcomes were mortality at longest follow-up and need for postoperative renal replacement therapy (RRT). Secondary postoperative outcomes investigated included myocardial injury, supraventricular arrhythmias, development of LCOS, acute kidney injury (AKI), duration of mechanical ventilation, intensive care unit and hospital lengths of stay, and incidence of hypotension during drug infusion.ResultsSix RCTs were included in the meta-analysis, five of which investigated only patients with LVEF ≤ 35% and one of which included predominantly patients with LCOS. Mortality was similar overall (OR 0.64 [0.37, 1.11], p = 0.11) but lower in the subgroup with LVEF < 35% (OR 0.51 [0.32, 0.82], p = 0.005). Need for RRT was reduced by levosimendan both overall (OR 0.63 [0.42, 0.94], p = 0.02) and in patients with LVEF < 35% (OR 0.55 [0.31, 0.97], p = 0.04). Among secondary outcomes, we found lower postoperative LCOS in patients with LVEF < 35% receiving levosimendan (OR 0.49 [0.27, 0.89], p = 0.02), lower overall AKI (OR 0.62 [0.42, 0.92], p = 0.02), and a trend toward lower mechanical support, both overall (p = 0.07) and in patients with LVEF < 35% (p = 0.05).ConclusionsLevosimendan reduces mortality in patients with preoperative severely reduced LVEF but does not affect overall mortality. Levosimendan reduces the need for RRT after high-risk cardiac surgery.
Highlights
Previous studies have shown beneficial effects of levosimendan in high-risk patients undergoing cardiac surgery
One recent meta-analysis showed that levosimendan seems to be the most effective drug in decreasing mortality after cardiac surgery [11], and another showed that the reduction in mortality and postoperative complications is driven by studies where levosimendan was used in patients with low left ventricular ejection fraction (LVEF) [12]
As shown in the PRISMA flow diagram in Additional file 2, after the evaluation of the remaining 252 findings, only 6 Randomized controlled trial (RCT) were judged to be of interest for our quantitative analyses: 5 RCTs included only patients with preoperative severely depressed LVEF [13, 19,20,21,22], and 1 RCT included both patients with preoperative severely depressed LVEF and patients with intra-/postoperative low cardiac output syndrome (LCOS) [14]
Summary
Previous studies have shown beneficial effects of levosimendan in high-risk patients undergoing cardiac surgery. Over the last two decades, the risk profile of patients undergoing cardiac surgery has increased significantly [1, 2], and currently more than 1 million cardiac surgery procedures are performed annually in the United States and Europe [3]. Older patients and those with a higher degree of comorbidities are currently referred for cardiac surgery [4], and, even if such patients may benefit from cardiac surgery, they are at increased risk for perioperative complications that result in high morbidity and mortality [5]. One recent meta-analysis showed that levosimendan seems to be the most effective drug in decreasing mortality after cardiac surgery [11], and another showed that the reduction in mortality and postoperative complications is driven by studies where levosimendan was used in patients with low LVEF [12]
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