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Levosimendan in patients with reduced left ventricular function undergoing isolated coronary or valve surgery.

Publication ,  Journal Article
van Diepen, S; Mehta, RH; Leimberger, JD; Goodman, SG; Fremes, S; Jankowich, R; Heringlake, M; Anstrom, KJ; Levy, JH; Luber, J; Nagpal, AD ...
Published in: J Thorac Cardiovasc Surg
June 2020

OBJECTIVE: In the Levosimendan in Patients with Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass (LEVO-CTS) trial, no differences in clinical outcomes were observed between levosimendan and placebo in a broad population of patients undergoing cardiac surgery. In previous studies, the benefits of levosimendan were most clearly evident in patients undergoing isolated coronary artery bypass grafting (CABG) surgery. In a prespecified analysis of LEVO-CTS, we compared treatment-related outcomes and costs across types of cardiac surgical procedures. METHODS: Overall, 563 (66.4%) patients underwent isolated CABG, 97 (11.4%) isolated valve, and 188 (22.2%) combined CABG/valve surgery. Outcomes included the co-primary 4-component composite (30-day mortality, 30-day renal replacement, 5-day myocardial infarction, or 5-day mechanical circulatory support), the 2-component composite (30-day mortality or 5-day mechanical circulatory support), 90-day mortality, low cardiac output syndrome (LCOS), and 30-day medical costs. RESULTS: The 4- and 2-component outcomes were not significantly different with levosimendan and placebo in patients undergoing CABG (15.2% vs 19.3% and 7.8% vs 10.4%), valve (49.0% vs 33.3% and 22.4% vs 2.1%), or combined procedures (39.6% vs 35.9% and 24.0% vs 19.6%). Ninety-day mortality was lower with levosimendan in isolated CABG (2.1% vs 7.9%; hazard ratio [HR], 0.26; 95% confidence interval [CI], 0.11-0.64), but not significantly different in valve (8.3% vs 2.0%; HR, 4.10; 95% CI, 0.46-36.72) or combined procedures (10.4% vs 7.6%; HR, 1.39; 95% CI, 0.53-3.64; interaction P = .011). LCOS (12.0% vs 22.1%; odds ratio, 0.48; 95% CI, 0.30-0.76; interaction P = .118) was significantly lower in levosimendan-treated patients undergoing isolated CABG. Excluding study drug costs, median and mean 30-day costs were $53,707 and $65,852 for levosimendan and $54,636 and $67,122 for placebo, with a 30-day mean difference (levosimendan - placebo) of -$1270 (bootstrap 95% CI, -$8722 to $6165). CONCLUSIONS: Levosimendan was associated with lower 90-day mortality and LCOS in patients undergoing isolated CABG, but not in those undergoing isolated valve or combined CABG/valve procedures.

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Published In

J Thorac Cardiovasc Surg

DOI

EISSN

1097-685X

Publication Date

June 2020

Volume

159

Issue

6

Start / End Page

2302 / 2309.e6

Location

United States

Related Subject Headings

  • Ventricular Function, Left
  • Ventricular Dysfunction, Left
  • Treatment Outcome
  • Time Factors
  • Simendan
  • Risk Factors
  • Risk Assessment
  • Respiratory System
  • Postoperative Complications
  • Middle Aged
 

Citation

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van Diepen, S., Mehta, R. H., Leimberger, J. D., Goodman, S. G., Fremes, S., Jankowich, R., … Alexander, J. H. (2020). Levosimendan in patients with reduced left ventricular function undergoing isolated coronary or valve surgery. J Thorac Cardiovasc Surg, 159(6), 2302-2309.e6. https://doi.org/10.1016/j.jtcvs.2019.06.020
Diepen, Sean van, Rajendra H. Mehta, Jeffrey D. Leimberger, Shaun G. Goodman, Stephen Fremes, Rachael Jankowich, Matthias Heringlake, et al. “Levosimendan in patients with reduced left ventricular function undergoing isolated coronary or valve surgery.J Thorac Cardiovasc Surg 159, no. 6 (June 2020): 2302-2309.e6. https://doi.org/10.1016/j.jtcvs.2019.06.020.
van Diepen S, Mehta RH, Leimberger JD, Goodman SG, Fremes S, Jankowich R, et al. Levosimendan in patients with reduced left ventricular function undergoing isolated coronary or valve surgery. J Thorac Cardiovasc Surg. 2020 Jun;159(6):2302-2309.e6.
van Diepen, Sean, et al. “Levosimendan in patients with reduced left ventricular function undergoing isolated coronary or valve surgery.J Thorac Cardiovasc Surg, vol. 159, no. 6, June 2020, pp. 2302-2309.e6. Pubmed, doi:10.1016/j.jtcvs.2019.06.020.
van Diepen S, Mehta RH, Leimberger JD, Goodman SG, Fremes S, Jankowich R, Heringlake M, Anstrom KJ, Levy JH, Luber J, Nagpal AD, Duncan AE, Argenziano M, Toller W, Teoh K, Knight JD, Lopes RD, Cowper PA, Mark DB, Alexander JH. Levosimendan in patients with reduced left ventricular function undergoing isolated coronary or valve surgery. J Thorac Cardiovasc Surg. 2020 Jun;159(6):2302-2309.e6.
Journal cover image

Published In

J Thorac Cardiovasc Surg

DOI

EISSN

1097-685X

Publication Date

June 2020

Volume

159

Issue

6

Start / End Page

2302 / 2309.e6

Location

United States

Related Subject Headings

  • Ventricular Function, Left
  • Ventricular Dysfunction, Left
  • Treatment Outcome
  • Time Factors
  • Simendan
  • Risk Factors
  • Risk Assessment
  • Respiratory System
  • Postoperative Complications
  • Middle Aged