Influence of Levosimendan on Severe Valvular Disease Patients with Atrial Fibrillation Undergoing Cardiac Surgery: A Randomized Controlled Trial_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

YUFeng-xu ¹ , FUYong ¹ , LIUHong-duan ¹ , LIXin ¹ , FANJing-xiu ² , LIAOBin ¹ , SHIYing-kang ²

1. Department of Cardiothoracic Surgery, The Affiliated Hospital of Luzhou Medical College, Luzhou 646000, Sichuan, P. R. China;
2. Department of Cardiovascular Surgery, West China Hospital, Sichuan University, Chengdu 610041, P. R. China;

Corresponding author：

Keywords：

Levosimendan; Valvular disease; Atrial fibrillation; Cardiac surgery

DOI：

10.7507/1007-4848.20150080

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Objective Through comparing the efficacy of levosimendan with dopamine for severe valvular disease patients with atrial fibrillation surgery to explore the efficacy and safety of levosimendan used in cardiac surgery. Methods We allocated 48 severe valvular disease patients with atrial fibrillation surgery into a dopamine group (24 patients with 15 males and 9 females at age of 55.0 ± 17.4 years) and a levosimendan group (24 patients with 18 males and 6 females at age of 52.3 ± 16.2 years) by random digital table in the Affiliated Hospital of Luzhou Medical College between February and June 2014. The effects of the two groups were compared. Results Hospitalization time (18.7±8.6 d vs 20.6±7.5 d, t=11.52, P=0.02) and the incidence of acute kidney injury(1/24 vs 5/24, χ₂=25.30, P=0.01) in the levosimendan group were lower than those in the dopamine group. There was no statistical difference between the two groups in other early clinical outcomes. At each postoperative time point, there was no statistical difference in creatine kinase isoenzyme (CK-MB) between the two groups. While 6 to 48 hours after operation, there were significant differences in cardiac troponin (cTnI) and brain natriuretic peptide(BNP) level between the two groups (P < 0.05). Five days after operation, the left ventricular ejection fraction(LVEF) in the levosimendan group was higher than that in the dopamine group with statistical difference. Conclusion Levosimendan used for severe valvular disease with atrial fibrillation surgery is safe and effective, and has certain myocardial protection and renal protection effect, while its mechanism still needs further study.

Citation： YUFeng-xu, FUYong, LIUHong-duan, LIXin, FANJing-xiu, LIAOBin, SHIYing-kang. Influence of Levosimendan on Severe Valvular Disease Patients with Atrial Fibrillation Undergoing Cardiac Surgery: A Randomized Controlled Trial. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2015, 22(4): 288-291. doi: 10.7507/1007-4848.20150080 Copy

1.	du Toit EF, Genis A, Opie LH, et al.A role for the RISK pathway and K (ATP) channels in pre-and post-conditioning induced by levosimendan in the isolated guinea pig heart.Br J Pharmacol, 2008, 154(1):41-50.
2.	Lilleberg J, Nieminen MS, Akkila J, et al.Effects of a new calcium sensitizer, levosimendan, on haemodynamics, coronary blood flow and myocardial substrate utilization early after coronary artery bypass grafting.Eur Heart J, 1998, 19(4):660-668.
3.	Packer M, Colucci W, Fisher L, et al.Effect of levosimendan on the short-term clinical course of patients with acutely decompensated heart failure.JCHF, 2013, 1(2):103-111.
4.	Toller W, Algotsson L, Guarracino F, et al.Perioperative use of levosimendan:best practice in operative settings.J Cardiothorac Vasc Anesth, 2013, 27(2):361-366.
5.	Gheorghiade M, Teerlink JR, Mebazaa A.Pharmacology of new agents for acute heart syndromes.Am J Cardiol, 2005, 96(6A):68G-73G.
6.	Antila S, Pesonen U, Lehtonen L, et al.Pharmacokinetics of levosi-mendan and its active metabolite OR-1896 in rapid and slow acetylators.Eur J Pharm Sci, 2004, 23(3):213-222.
7.	Puttonen J, Laine T, Ramela M, et al.Pharmacokinetics and excre-tion balance of OR-1896, a pharmacologically active metabolite of levosimendan, in healthy men.Eur J Pharm Sci, 2007, 32(4-5):271-277.
8.	Erdei N, Papp Z, Pollesello P, et al.The levosimendan metabolite OR-1896 elicits vasodilation by activating the K (ATP) and BK (Ca) channels in rat isolated arterioles.Br J Pharmacol, 2006, 148(5):696-702.
9.	Malfatto G, Della Rosa F, Rella V, et al.Prognostic value of nonin-vasive hemodynamic evaluation of the acute effect of levosimendan in advanced heart failure.J Cardiovasc Med (Hagerstown), 2014, 15(4):322-330.
10.	Givertz MM, Andreou C, Conrad CH, et al.Direct myocardial effects of levosimendan in humans with left ventricular dysfunc-tion:alteration of force-frequency and relaxation-frequency relationships.Circulation, 2007, 115(10):1218-1124.
11.	Tritapepe L, De Santis V, Vitale D, et al.Preconditioning effects of levosimendan in coronary artery bypass grafting-a pilot study.Br J Anaesth, 2006, 96(6):694-700.
12.	Papp Z, Edes I, Fruhwald S, et al.Levosimendan:molecular mechanisms and clinical implications:consensus of experts on the mechanisms of action of levosimendan.Int J Cardiol, 2012, 159(2):82-87.
13.	Eris C, Yavuz S, Toktas F, et al.Preoperative usages of levosimendan in patients undergoing coronary artery bypass grafting.Int J Clin Exp Med, 2014, 7(1):219-229.
14.	Shah B, Sharma P, Brahmbhatt A, et al.Study of levosimendan during off-pump coronary artery bypass grafting in patients with LV dysfunction:a double-blind randomized study.Indian J Pharmacol, 2014, 46(1):29-34.
15.	Erb J, Beutlhauser T, Feldheiser A, et al.Influence of levosimendan on organ dysfunction in patients with severely reduced left ventricular function undergoing cardiac surgery.J Int Med Res, 2014, 42(3):750-764.
16.	Niu ZZ, Wu SM, Sun WY, et al.Perioperative levosimendan therapy is associated with a lower incidence of acute kidney injury after cardiac surgery:a meta-analysis.J Cardiovasc Pharmacol, 2014, 63(2):107-112.
17.	Gandham R, Syamasundar A, Ravulapalli H, et al.A comparison of hemodynamic effects of levosimendan and dobutamine in patients undergoing mitral valverepair/replacement for severe mitral stenosis.Ann Card Anaesth, 2013, 16(1):11-15.
18.	Ersoy O, Boysan E, Unal EU, et al.Effectiveness of prophylactic levosimendan in high-risk valve surgery patients.Cardiovasc J Afr, 2013, 24(7):260-264.
19.	Malmberg M, Vähäsilta T, Saraste A, et al.Intracoronary levosime-ndan during ischemia prevents myocardial apoptosis.Front Physiol, 2012, 14(3):17.

1. du Toit EF, Genis A, Opie LH, et al.A role for the RISK pathway and K (ATP) channels in pre-and post-conditioning induced by levosimendan in the isolated guinea pig heart.Br J Pharmacol, 2008, 154(1):41-50.
2. Lilleberg J, Nieminen MS, Akkila J, et al.Effects of a new calcium sensitizer, levosimendan, on haemodynamics, coronary blood flow and myocardial substrate utilization early after coronary artery bypass grafting.Eur Heart J, 1998, 19(4):660-668.
3. Packer M, Colucci W, Fisher L, et al.Effect of levosimendan on the short-term clinical course of patients with acutely decompensated heart failure.JCHF, 2013, 1(2):103-111.
4. Toller W, Algotsson L, Guarracino F, et al.Perioperative use of levosimendan:best practice in operative settings.J Cardiothorac Vasc Anesth, 2013, 27(2):361-366.
5. Gheorghiade M, Teerlink JR, Mebazaa A.Pharmacology of new agents for acute heart syndromes.Am J Cardiol, 2005, 96(6A):68G-73G.
6. Antila S, Pesonen U, Lehtonen L, et al.Pharmacokinetics of levosi-mendan and its active metabolite OR-1896 in rapid and slow acetylators.Eur J Pharm Sci, 2004, 23(3):213-222.
7. Puttonen J, Laine T, Ramela M, et al.Pharmacokinetics and excre-tion balance of OR-1896, a pharmacologically active metabolite of levosimendan, in healthy men.Eur J Pharm Sci, 2007, 32(4-5):271-277.
8. Erdei N, Papp Z, Pollesello P, et al.The levosimendan metabolite OR-1896 elicits vasodilation by activating the K (ATP) and BK (Ca) channels in rat isolated arterioles.Br J Pharmacol, 2006, 148(5):696-702.
9. Malfatto G, Della Rosa F, Rella V, et al.Prognostic value of nonin-vasive hemodynamic evaluation of the acute effect of levosimendan in advanced heart failure.J Cardiovasc Med (Hagerstown), 2014, 15(4):322-330.
10. Givertz MM, Andreou C, Conrad CH, et al.Direct myocardial effects of levosimendan in humans with left ventricular dysfunc-tion:alteration of force-frequency and relaxation-frequency relationships.Circulation, 2007, 115(10):1218-1124.
11. Tritapepe L, De Santis V, Vitale D, et al.Preconditioning effects of levosimendan in coronary artery bypass grafting-a pilot study.Br J Anaesth, 2006, 96(6):694-700.
12. Papp Z, Edes I, Fruhwald S, et al.Levosimendan:molecular mechanisms and clinical implications:consensus of experts on the mechanisms of action of levosimendan.Int J Cardiol, 2012, 159(2):82-87.
13. Eris C, Yavuz S, Toktas F, et al.Preoperative usages of levosimendan in patients undergoing coronary artery bypass grafting.Int J Clin Exp Med, 2014, 7(1):219-229.
14. Shah B, Sharma P, Brahmbhatt A, et al.Study of levosimendan during off-pump coronary artery bypass grafting in patients with LV dysfunction:a double-blind randomized study.Indian J Pharmacol, 2014, 46(1):29-34.
15. Erb J, Beutlhauser T, Feldheiser A, et al.Influence of levosimendan on organ dysfunction in patients with severely reduced left ventricular function undergoing cardiac surgery.J Int Med Res, 2014, 42(3):750-764.
16. Niu ZZ, Wu SM, Sun WY, et al.Perioperative levosimendan therapy is associated with a lower incidence of acute kidney injury after cardiac surgery:a meta-analysis.J Cardiovasc Pharmacol, 2014, 63(2):107-112.
17. Gandham R, Syamasundar A, Ravulapalli H, et al.A comparison of hemodynamic effects of levosimendan and dobutamine in patients undergoing mitral valverepair/replacement for severe mitral stenosis.Ann Card Anaesth, 2013, 16(1):11-15.
18. Ersoy O, Boysan E, Unal EU, et al.Effectiveness of prophylactic levosimendan in high-risk valve surgery patients.Cardiovasc J Afr, 2013, 24(7):260-264.
19. Malmberg M, Vähäsilta T, Saraste A, et al.Intracoronary levosime-ndan during ischemia prevents myocardial apoptosis.Front Physiol, 2012, 14(3):17.

Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Influence of Levosimendan on Severe Valvular Disease Patients with Atrial Fibrillation Undergoing Cardiac Surgery: A Randomized Controlled Trial

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