CLINICAL TRIAL
JOURNAL ARTICLE
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Levosimendan improves hemodynamic status in critically ill patients with severe aortic stenosis and left ventricular dysfunction: an interventional study.

AIMS: To study the hemodynamic effect of levosimendan administration in acute heart failure patients with severe aortic stenosis (AS) and reduced left ventricular ejection fraction (LVEF).

METHODS: Hemodynamic response to 24 h intravenous levosimendan infusion (0.1 μg/kg/min without a loading dose) in patients with severe AS (aortic valve area ≤1 cm(2) , time-velocity integral between left ventricular out-flow tract and aortic valve <0.25), reduced LVEF (≤40%), and a depressed cardiac index (CI) <2.2 L/min/m(2) was determined in a sequential group of nine patients aged 76 ± 10 years (5 men).

RESULTS: Baseline mean ejection fraction was 33 ± 0.7%; mean aortic valve area was 0.37 ±0.11 cm(2) /m(2) ; peak and mean gradients of 63.6 ± 20.53 and 36.7 ± 12.62 mmHg, respectively; and mean CI was 1.65 ± 0.20 L/min/m(2) . At 6 and 12 h of levosimendan therapy, mean CI had increased to 2.00 ± 0.41 L/min/m(2) (P = 0.02) and 2.17 ± 0.40 L/min/m(2) (P = 0.01), respectively. At 24 h, mean CI had increased further to 2.37 ± 0.49 L/min/m(2) (P = 0.01). A significant beneficial effect was also observed in pulmonary capillary wedge pressure, pulmonary artery mean pressure, central venous pressure, systemic vascular resistances, pulmonary vascular resistances, stroke volume index, left ventricular stroke work index. NTproBNP levels decreased at 24 h of levosimendan treatment. Levosimendan infusion was also well tolerated. Five patients subsequently underwent aortic valve surgery replacement. One died (of postoperative multiorgan failure). At 30 days, overall survival was 75%.

CONCLUSIONS: Levosimendan administration improves hemodynamic parameters in critically ill patients with severe AS and reduced LVEF. In our study, it provides a safe and effective bridge to aortic-valve replacement or oral vasodilator therapy in surgical contraindicated patients. A controlled study is needed to confirm these preliminary findings.

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