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Volumn 182, Issue , 2016, Pages 62-71

Levosimendan in patients with left ventricular systolic dysfunction undergoing cardiac surgery on cardiopulmonary bypass: Rationale and study design of the Levosimendan in Patients with Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass (LEVO-CTS) trial

Author keywords

[No Author keywords available]

Indexed keywords

LEVOSIMENDAN; CARDIOVASCULAR AGENT; HYDRAZONE DERIVATIVE; PYRIDAZINE DERIVATIVE; SIMENDAN;

EID: 84988922521     PISSN: 00028703     EISSN: 10976744     Source Type: Journal    
DOI: 10.1016/j.ahj.2016.09.001     Document Type: Article
Times cited : (23)

References (43)
  • 1
    • 84863985666 scopus 로고    scopus 로고
    • Decreasing prevalence but increasing importance of left ventricular dysfunction and reoperative surgery in prediction of mortality in coronary artery bypass surgery: trends over 18 years
    • 1. Algarni, K.D., Elhenawy, A.M., Maganti, M., et al. Decreasing prevalence but increasing importance of left ventricular dysfunction and reoperative surgery in prediction of mortality in coronary artery bypass surgery: trends over 18 years. J Thorac Cardiovasc Surg 144 (2012), 340–346.
    • (2012) J Thorac Cardiovasc Surg , vol.144 , pp. 340-346
    • Algarni, K.D.1    Elhenawy, A.M.2    Maganti, M.3
  • 2
    • 39449093040 scopus 로고    scopus 로고
    • Clinical characteristics and in-hospital outcomes of patients with cardiogenic shock undergoing coronary artery bypass surgery: insights from the society of thoracic surgery national cardiac database
    • 2. Mehta, R.H., Grab, J.D., O'Brien, S.M., et al. Clinical characteristics and in-hospital outcomes of patients with cardiogenic shock undergoing coronary artery bypass surgery: insights from the society of thoracic surgery national cardiac database. Circulation 117 (2008), 876–885.
    • (2008) Circulation , vol.117 , pp. 876-885
    • Mehta, R.H.1    Grab, J.D.2    O'Brien, S.M.3
  • 3
    • 83155173970 scopus 로고    scopus 로고
    • 2011 ACCF/AHA guideline for coronary artery bypass graft surgery: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines
    • 3. Hillis, L.D., Smith, P.K., Anderson, J.L., et al. 2011 ACCF/AHA guideline for coronary artery bypass graft surgery: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation 124 (2011), e652–e735.
    • (2011) Circulation , vol.124 , pp. e652-e735
    • Hillis, L.D.1    Smith, P.K.2    Anderson, J.L.3
  • 4
    • 84902479895 scopus 로고    scopus 로고
    • 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines
    • 4. Nishimura, R.A., Otto, C.M., Bonow, R.O., et al. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Thorac Cardiovasc Surg 148 (2014), e1–e132.
    • (2014) J Thorac Cardiovasc Surg , vol.148 , pp. e1-e132
    • Nishimura, R.A.1    Otto, C.M.2    Bonow, R.O.3
  • 5
    • 84888296344 scopus 로고    scopus 로고
    • Effect of levosimendan on survival and adverse events after cardiac surgery: a meta-analysis
    • 5. Harrison, R.W., Hasselblad, V., Mehta, R.H., et al. Effect of levosimendan on survival and adverse events after cardiac surgery: a meta-analysis. J Cardiothorac Vasc Anesth 27 (2013), 1224–1232.
    • (2013) J Cardiothorac Vasc Anesth , vol.27 , pp. 1224-1232
    • Harrison, R.W.1    Hasselblad, V.2    Mehta, R.H.3
  • 6
    • 84928891158 scopus 로고    scopus 로고
    • A Bayesian network meta-analysis on the effect of inodilatory agents on mortality
    • 6. Greco, T., Calabro, M.G., Covello, R.D., et al. A Bayesian network meta-analysis on the effect of inodilatory agents on mortality. Br J Anaesth, 2015, 10.1093/bja/aeu446.
    • (2015) Br J Anaesth
    • Greco, T.1    Calabro, M.G.2    Covello, R.D.3
  • 7
    • 84930763870 scopus 로고    scopus 로고
    • Preoperative and perioperative use of levosimendan in cardiac surgery: European expert opinion
    • 7. Toller, W., Heringlake, M., Guarracino, F., et al. Preoperative and perioperative use of levosimendan in cardiac surgery: European expert opinion. Int J Cardiol 84 (2015), 323–336.
    • (2015) Int J Cardiol , vol.84 , pp. 323-336
    • Toller, W.1    Heringlake, M.2    Guarracino, F.3
  • 8
    • 84902251376 scopus 로고    scopus 로고
    • Levosimendan improves renal outcome in cardiac surgery: a randomized trial
    • 8. Baysal, A., Yanartas, M., Dogukan, M., et al. Levosimendan improves renal outcome in cardiac surgery: a randomized trial. J Cardiothorac Vasc Anesth 28 (2014), 586–594.
    • (2014) J Cardiothorac Vasc Anesth , vol.28 , pp. 586-594
    • Baysal, A.1    Yanartas, M.2    Dogukan, M.3
  • 9
    • 84988963059 scopus 로고    scopus 로고
    • Levosimendan in Patients with Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass (LEVO-CTS) trial
    • [Accessed March 7, 2015]
    • 9. Levosimendan in Patients with Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass (LEVO-CTS) trial. https://clinicaltrials.gov/ct2/show/NCT02025621?term=LEVO+CTS&rank=1 [Accessed March 7, 2015].
  • 10
    • 84988959670 scopus 로고    scopus 로고
    • Levosimendan (Simdax) Investigator's brochure edition 7
    • Orion Pharma; Oxygen Biotherapeutics
    • 10. IB, Levosimendan (Simdax) Investigator's brochure edition 7. 2014, Orion Pharma; Oxygen Biotherapeutics.
    • (2014)
    • IB1
  • 13
    • 79952607782 scopus 로고    scopus 로고
    • Acetylation status does not affect levosimendan's hemodynamic effects in heart failure patients
    • 13. Kivikko, M., Sundberg, S., Karlsson, M.O., et al. Acetylation status does not affect levosimendan's hemodynamic effects in heart failure patients. Scand Cardiovasc J 45 (2010), 86–90.
    • (2010) Scand Cardiovasc J , vol.45 , pp. 86-90
    • Kivikko, M.1    Sundberg, S.2    Karlsson, M.O.3
  • 14
    • 0036795429 scopus 로고    scopus 로고
    • Pharmacokinetics of levosimendan and its metabolites during and after a 24-hour continuous infusion in patients with severe heart failure
    • 14. Kivikko, M., Antila, S., Eha, J., et al. Pharmacokinetics of levosimendan and its metabolites during and after a 24-hour continuous infusion in patients with severe heart failure. Int J Clin Pharmacol Ther 40 (2002), 465–471.
    • (2002) Int J Clin Pharmacol Ther , vol.40 , pp. 465-471
    • Kivikko, M.1    Antila, S.2    Eha, J.3
  • 15
    • 58249132859 scopus 로고    scopus 로고
    • Levosimendan facilitates weaning from cardiopulmonary bypass in patients undergoing coronary artery bypass grafting with impaired left ventricular function
    • 15. Eriksson, H.I., Jalonen, J.R., Heikkinen, L.O., et al. Levosimendan facilitates weaning from cardiopulmonary bypass in patients undergoing coronary artery bypass grafting with impaired left ventricular function. Ann Thorac Surg 87 (2009), 448–454.
    • (2009) Ann Thorac Surg , vol.87 , pp. 448-454
    • Eriksson, H.I.1    Jalonen, J.R.2    Heikkinen, L.O.3
  • 16
    • 0033696857 scopus 로고    scopus 로고
    • Myocardial efficiency during levosimendan infusion in congestive heart failure
    • 16. Ukkonen, H., Saraste, M., Akkila, J., et al. Myocardial efficiency during levosimendan infusion in congestive heart failure. Clin Pharmacol Ther 68 (2000), 522–531.
    • (2000) Clin Pharmacol Ther , vol.68 , pp. 522-531
    • Ukkonen, H.1    Saraste, M.2    Akkila, J.3
  • 17
    • 0031976338 scopus 로고    scopus 로고
    • Effects of a new calcium sensitizer, levosimendan, on haemodynamics, coronary blood flow and myocardial substrate utilization early after coronary artery bypass grafting
    • 17. Lilleberg, J., Nieminen, M.S., Akkilla, 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 19 (1998), 660–668.
    • (1998) Eur Heart J , vol.19 , pp. 660-668
    • Lilleberg, J.1    Nieminen, M.S.2    Akkilla, J.3
  • 18
    • 84867485658 scopus 로고    scopus 로고
    • Preoperative levosimendan decreses mortality and the development of low cardiac output syndrome in high-risk patients with severe left ventricular systolic dysfunction undergoing coronary artery bypass grafting with cardiopulmonary bypass
    • 18. Levin, R., Degrange, M., Del Mazo, C., et al. Preoperative levosimendan decreses mortality and the development of low cardiac output syndrome in high-risk patients with severe left ventricular systolic dysfunction undergoing coronary artery bypass grafting with cardiopulmonary bypass. Exp Clin Cardiol 17 (2012), 125–130.
    • (2012) Exp Clin Cardiol , vol.17 , pp. 125-130
    • Levin, R.1    Degrange, M.2    Del Mazo, C.3
  • 19
    • 34047270901 scopus 로고    scopus 로고
    • The effects of levosimendan in cardiac surgery patients with poor left ventricular function
    • 19. De Hert, S.G., Lorsomradee, S., Cromheecke, S., et al. The effects of levosimendan in cardiac surgery patients with poor left ventricular function. Anesth Analg 104 (2007), 766–773.
    • (2007) Anesth Analg , vol.104 , pp. 766-773
    • De Hert, S.G.1    Lorsomradee, S.2    Cromheecke, S.3
  • 20
    • 46449138711 scopus 로고    scopus 로고
    • The calcium sensitizer levosimendan gives superior results to dobutamine in postoperative low cardiac output syndrome
    • 20. Levin, R., Degrange, M., Del Mazo, C., et al. The calcium sensitizer levosimendan gives superior results to dobutamine in postoperative low cardiac output syndrome. Rev Esp Cardiol 61 (2008), 471–479.
    • (2008) Rev Esp Cardiol , vol.61 , pp. 471-479
    • Levin, R.1    Degrange, M.2    Del Mazo, C.3
  • 21
    • 33644831104 scopus 로고    scopus 로고
    • Preoperative use of levosimendan in 2 patients with severe aortic stenosis and left ventricular dysfunction
    • 21. Prior, D.L., Flaim, B.D., MacIsaac, A.I., et al. Preoperative use of levosimendan in 2 patients with severe aortic stenosis and left ventricular dysfunction. Heart Lung Circ 15 (2006), 56–58.
    • (2006) Heart Lung Circ , vol.15 , pp. 56-58
    • Prior, D.L.1    Flaim, B.D.2    MacIsaac, A.I.3
  • 22
    • 79951574278 scopus 로고    scopus 로고
    • Preoperative levosimendan infusion in combined aortic valve and coronary bypass surgery
    • 22. Leppikangas, H., Järvelä, K., Sisto, T., et al. Preoperative levosimendan infusion in combined aortic valve and coronary bypass surgery. Br J Anaesth 106 (2011), 298–304.
    • (2011) Br J Anaesth , vol.106 , pp. 298-304
    • Leppikangas, H.1    Järvelä, K.2    Sisto, T.3
  • 23
    • 84889246150 scopus 로고    scopus 로고
    • Effectiveness of prophylactic levosimendan in high-risk valve surgery patients
    • 23. Ersoy, O., Boysan, E., Unal, E.U., et al. Effectiveness of prophylactic levosimendan in high-risk valve surgery patients. Cardiovasc J Afr 24 (2013), 260–264.
    • (2013) Cardiovasc J Afr , vol.24 , pp. 260-264
    • Ersoy, O.1    Boysan, E.2    Unal, E.U.3
  • 24
    • 67649827173 scopus 로고    scopus 로고
    • The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 1—coronary artery bypass grafting surgery
    • 24. Shahian, D.M., O'Brien, S.M., Filardo, G., et al. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 1—coronary artery bypass grafting surgery. Ann Thorac Surg 88:1 Suppl. (2009), S2–22.
    • (2009) Ann Thorac Surg , vol.88 , Issue.1 , pp. S2-22
    • Shahian, D.M.1    O'Brien, S.M.2    Filardo, G.3
  • 25
    • 67649816665 scopus 로고    scopus 로고
    • The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 2—isolated valve surgery
    • 25. O'Brien, S.M., Shahian, D.M., Filardo, G., et al. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 2—isolated valve surgery. Ann Thorac Surg 88:1 Suppl. (2009), S23–S42.
    • (2009) Ann Thorac Surg , vol.88 , Issue.1 , pp. S23-S42
    • O'Brien, S.M.1    Shahian, D.M.2    Filardo, G.3
  • 26
    • 67649786427 scopus 로고    scopus 로고
    • The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 3—valve plus coronary artery bypass grafting surgery
    • 26. Shahian, D.M., O'Brien, S.M., Filardo, G., et al. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 3—valve plus coronary artery bypass grafting surgery. Ann Thorac Surg 88:1 Suppl. (2009), S43–S62.
    • (2009) Ann Thorac Surg , vol.88 , Issue.1 , pp. S43-S62
    • Shahian, D.M.1    O'Brien, S.M.2    Filardo, G.3
  • 27
    • 0018687930 scopus 로고
    • A multiple testing procedure for clinical trials
    • 27. O'Brien, P.C., Fleming, T.R., A multiple testing procedure for clinical trials. Biometrics 35 (1979), 549–556.
    • (1979) Biometrics , vol.35 , pp. 549-556
    • O'Brien, P.C.1    Fleming, T.R.2
  • 28
    • 0037306242 scopus 로고    scopus 로고
    • Monitoring mortality at interim analyses while testing a composite endpoint at the final analysis
    • 28. Chen, Y.H., DeMets, D.L., Lan, K.K., Monitoring mortality at interim analyses while testing a composite endpoint at the final analysis. Control Clin Trials 24 (2003), 16–27.
    • (2003) Control Clin Trials , vol.24 , pp. 16-27
    • Chen, Y.H.1    DeMets, D.L.2    Lan, K.K.3
  • 29
    • 36249007028 scopus 로고    scopus 로고
    • Statistical considerations for testing multiple endpoints in group sequential or adaptive clinical trials
    • 29. Hung, H.M., Wang, S.J., O'Neill, R., Statistical considerations for testing multiple endpoints in group sequential or adaptive clinical trials. J Biopharm Stat 17 (2007), 1201–1210.
    • (2007) J Biopharm Stat , vol.17 , pp. 1201-1210
    • Hung, H.M.1    Wang, S.J.2    O'Neill, R.3
  • 30
    • 80155211948 scopus 로고    scopus 로고
    • Predictors of low cardiac output syndrome after isolated coronary artery bypass surgery: trends over 20 years
    • 30. Algarni, K.D., Maganti, M., Yau, T.M., Predictors of low cardiac output syndrome after isolated coronary artery bypass surgery: trends over 20 years. Ann Thorac Surg 92 (2011), 1678–1684.
    • (2011) Ann Thorac Surg , vol.92 , pp. 1678-1684
    • Algarni, K.D.1    Maganti, M.2    Yau, T.M.3
  • 31
    • 82455212056 scopus 로고    scopus 로고
    • Postoperative inotrope and vasopressor use following CABG: outcome data from the CAPS-care study
    • 31. Williams, J.B., Hernandez, A.F., Li, S., et al. Postoperative inotrope and vasopressor use following CABG: outcome data from the CAPS-care study. J Card Surg 26 (2011), 572–578.
    • (2011) J Card Surg , vol.26 , pp. 572-578
    • Williams, J.B.1    Hernandez, A.F.2    Li, S.3
  • 32
    • 0036673089 scopus 로고    scopus 로고
    • The effectiveness and relative effectiveness of intravenous inotropic drugs acting through the adrenergic pathway in patients with heart failure—a meta-regression analysis
    • 32. Thackray, S., Easthaugh, J., Freemantle, N., et al. The effectiveness and relative effectiveness of intravenous inotropic drugs acting through the adrenergic pathway in patients with heart failure—a meta-regression analysis. Eur J Heart Fail 4 (2002), 515–529.
    • (2002) Eur J Heart Fail , vol.4 , pp. 515-529
    • Thackray, S.1    Easthaugh, J.2    Freemantle, N.3
  • 33
    • 45149133687 scopus 로고    scopus 로고
    • Perioperative use of dobutamine in cardiac surgery and adverse cardiac outcome: propensity-adjusted analyses
    • 33. Fellahi, J.L., Parienti, J.J., Hanouz, J.L., et al. Perioperative use of dobutamine in cardiac surgery and adverse cardiac outcome: propensity-adjusted analyses. Anesthesiology 108 (2008), 979–987.
    • (2008) Anesthesiology , vol.108 , pp. 979-987
    • Fellahi, J.L.1    Parienti, J.J.2    Hanouz, J.L.3
  • 34
    • 79953814462 scopus 로고    scopus 로고
    • Short-term survival by treatment among patients hospitalized with acute heart failure: the global ALARM-HF registry using propensity scoring methods
    • 34. Mebazaa, A., Parissis, J., Porcher, R., et al. Short-term survival by treatment among patients hospitalized with acute heart failure: the global ALARM-HF registry using propensity scoring methods. Intensive Care Med 37 (2011), 290–301.
    • (2011) Intensive Care Med , vol.37 , pp. 290-301
    • Mebazaa, A.1    Parissis, J.2    Porcher, R.3
  • 35
    • 0033635679 scopus 로고    scopus 로고
    • Prophylactic value of preincision intra-aortic balloon pump: analysis of a statewide experience
    • 35. Holman, W.L., Li, Q., Kiefe, C.I., et al. Prophylactic value of preincision intra-aortic balloon pump: analysis of a statewide experience. J Thorac Cardiovasc Surg 120 (2000), 1112–1119.
    • (2000) J Thorac Cardiovasc Surg , vol.120 , pp. 1112-1119
    • Holman, W.L.1    Li, Q.2    Kiefe, C.I.3
  • 36
    • 68049088673 scopus 로고    scopus 로고
    • Prophylactic intra-aortic balloon pump in high-risk patients undergoing coronary artery bypass grafting: a propensity score analysis
    • 36. Miceli, A., Fiorani, B., Danesi, T.H., et al. Prophylactic intra-aortic balloon pump in high-risk patients undergoing coronary artery bypass grafting: a propensity score analysis. Interact Cardiovasc Thorac Surg 9 (2009), 291–294.
    • (2009) Interact Cardiovasc Thorac Surg , vol.9 , pp. 291-294
    • Miceli, A.1    Fiorani, B.2    Danesi, T.H.3
  • 37
    • 77950521752 scopus 로고    scopus 로고
    • The need for intra aortic balloon pump support following open heart surgery: risk analysis and outcome
    • 37. Parissis, H., Leotsinidis, M., Akbar, M.T., et al. The need for intra aortic balloon pump support following open heart surgery: risk analysis and outcome. J Cardiothorac Surg, 5, 2010, 20.
    • (2010) J Cardiothorac Surg , vol.5 , pp. 20
    • Parissis, H.1    Leotsinidis, M.2    Akbar, M.T.3
  • 38
    • 34548162441 scopus 로고    scopus 로고
    • A decade of acute outcomes in post-cardiac surgery ventricular assist device implantation: data from the Society of Thoracic Surgeons' National Cardiac Database
    • 38. Hernandez, A.F., Grab, J.D., Gammie, J.S., et al. A decade of acute outcomes in post-cardiac surgery ventricular assist device implantation: data from the Society of Thoracic Surgeons' National Cardiac Database. Circulation 116 (2007), 606–612.
    • (2007) Circulation , vol.116 , pp. 606-612
    • Hernandez, A.F.1    Grab, J.D.2    Gammie, J.S.3
  • 39
    • 84902166172 scopus 로고    scopus 로고
    • Guidance for Industry. Enrichment strategies for clinical trials to support approval of human drugs and biological products
    • [Accessed March 26, 2015]
    • 39. Guidance for Industry. Enrichment strategies for clinical trials to support approval of human drugs and biological products. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm332181.pdf [Accessed March 26, 2015].
  • 40
    • 0029030616 scopus 로고
    • Report cards on cardiac surgeons. Assessing New York State's approach
    • 40. Green, J., Wintfeld, N., Report cards on cardiac surgeons. Assessing New York State's approach. N Engl J Med 332 (1995), 1229–1232.
    • (1995) N Engl J Med , vol.332 , pp. 1229-1232
    • Green, J.1    Wintfeld, N.2
  • 41
    • 0030027348 scopus 로고    scopus 로고
    • Outmigration for coronary bypass surgery in an era of public dissemination of clinical outcomes
    • 41. Omoigui, N.A., Miller, D.P., Brown, K.J., et al. Outmigration for coronary bypass surgery in an era of public dissemination of clinical outcomes. Circulation 93 (1996), 27–33.
    • (1996) Circulation , vol.93 , pp. 27-33
    • Omoigui, N.A.1    Miller, D.P.2    Brown, K.J.3
  • 42
    • 33947498821 scopus 로고    scopus 로고
    • Eligibility criteria of randomized controlled trials published in high-impact general medical journals: a systematic sampling review
    • 42. Van Spall, H.G., Toren, A., Kiss, A., et al. Eligibility criteria of randomized controlled trials published in high-impact general medical journals: a systematic sampling review. JAMA 297 (2007), 1233–1240.
    • (2007) JAMA , vol.297 , pp. 1233-1240
    • Van Spall, H.G.1    Toren, A.2    Kiss, A.3
  • 43
    • 84966441045 scopus 로고    scopus 로고
    • A randomized controlled trial of levosimendan to reduce mortality in high-risk cardiac surgery patients (CHEETAH): rationale and design
    • 43. Zangrillo, A., Alvaro, G., Pisano, A., et al. A randomized controlled trial of levosimendan to reduce mortality in high-risk cardiac surgery patients (CHEETAH): rationale and design. Am Heart J 177 (2016), 68–73.
    • (2016) Am Heart J , vol.177 , pp. 68-73
    • Zangrillo, A.1    Alvaro, G.2    Pisano, A.3


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