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J Thorac Cardiovasc Surg. 2019 Jun 21. pii: S0022-5223(19)31278-4. doi: 10.1016/j.jtcvs.2019.06.020. [Epub ahead of print]

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

Author information

1
Division of Cardiology, Departments of Critical Care and Medicine, University of Alberta, Edmonton, Alberta, Canada; Canadian VIGOUR Center, University of Alberta, Edmonton, Alberta, Canada. Electronic address: sv9@ualberta.ca.
2
Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.
3
Canadian VIGOUR Center, University of Alberta, Edmonton, Alberta, Canada; Terrence Donnelly Heart Centre, Division of Cardiology, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
4
Schulich Heart Center, University of Toronto, Toronto, Ontario, Canada.
5
Tenax Therapeutics, Morrisville, NC.
6
University of Lübeck, Lübeck, Germany.
7
Franciscan Health System, Tacoma, Wash.
8
London Health Sciences Centre, London, Ontario, Canada.
9
Cleveland Clinic, Cleveland, Ohio.
10
Columbia University Medical Center, New York, NY.
11
Medical University of Graz, Graz, Austria.
12
Southlake Regional Health Center, Newmarket, Ontario, Canada.

Abstract

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.

KEYWORDS:

Levosimindan; cardiac surgery; coronary artery bypass grafting; cost; low cardiac output syndrome; mortality; valve surgery

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