Key result
Prophylactic levosimendan significantly improved cardiac index at 24 hours compared to control (3.84 vs 2.94 l/min/m², p=0.001) in high-risk patients undergoing cardiac valve surgery.
Why the study?
Does prophylactic levosimendan infusion improve peri-operative haemodynamics in high-risk cardiac valve surgery patients with low ejection fraction and/or severe pulmonary arterial hypertension?
RCT (n=20)
Randomized into two groups
No
Does prophylactic levosimendan infusion improve peri-operative haemodynamics in high-risk cardiac valve surgery patients with low ejection fraction and/or severe pulmonary arterial hypertension?
Absolute Event Rate: 3.84% vs 2.94%
p-value: p=0.001
Prophylactic levosimendan improves peri-operative haemodynamics and facilitates weaning from cardiopulmonary bypass in high-risk patients undergoing cardiac valve surgery.
Supports prophylactic levosimendan in high-risk valve surgery; extends perioperative RCT evidence to this population.
OBJECTIVE: Levosimendan has anti-ischaemic effects, improves myocardial contractility and increases systemic, pulmonary and coronary vasodilatation. These properties suggest potential advantages in high-risk cardiac valve surgery patients where cardioprotection would be valuable. The present study investigated the peri-operative haemodynamic effects of prophylactic levosimendan infusion in cardiac valve surgery patients with low ejection fraction and/or severe pulmonary arterial hypertension. METHODS: Between May 2006 and July 2007, 20 consecutive patients with severe pulmonary arterial hypertension (systolic pulmonary artery pressure ≥ 60 mmHg) and/or low ejection fraction (< 50%) who underwent valve surgery in our clinic were included in the study and randomised into two groups. Levosimendan was administered to 10 patients in group I and not to the 10 patients in the control group. Cardiac output (CO), cardiac index (CI), systemic vascular resistance (SVR), pulmonary vascular resistance (PVR) and mean pulmonary artery pressure (MPAP) were recorded for each patient preoperatively and for 24 hours following the operation. RESULTS: CO and CI values were higher in the levosimendan group during the study period (p < 0.05). MPAP and PVR values were significantly lower in the levosimendan group for the 24-hour period (p < 0.05) and SVR values were significantly lower after 24 hours in both groups. When clinical results were considered, no difference in favour of levosimendan was detected regarding the mortality and morbidity rates between the groups. CONCLUSION: Levosimendan improved the haemodynamics in cardiac valve surgery patients with low ejection fraction and/or severe pulmonary arterial hypertension, and facilitated weaning from cardiopulmonary bypass in such high-risk patients when started as a prophylactic agent.
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Ersoy et al. (2013) conducted an RCT in Cardiac valve disease with low ejection fraction and/or severe pulmonary arterial hypertension (n=20). Levosimendan vs. Control (no levosimendan) was evaluated on Cardiac index at 24 hours (p=0.001). Prophylactic levosimendan significantly improved cardiac index at 24 hours compared to control (3.84 vs 2.94 l/min/m², p=0.001) in high-risk patients undergoing cardiac valve surgery.
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