TY - JOUR

T1 - Levosimendan in Patients with Low Cardiac Output Syndrome After Cardiac Surgery: A Substudy of the Multicenter Randomized CHEETAH Trial

AU - Boboshko, Vladimir

AU - Lomivorotov, Vladimir

AU - Ruzankin, Pavel

AU - Khrushchev, Sergey

AU - Lomivorotova, Liudmila

AU - Monaco, Fabrizio

AU - Calabrò, Maria Grazia

AU - Comis, Marco

AU - Bove, Tiziana

AU - Pisano, Antonio

AU - Belletti, Alessandro

N1 - The study of P. Ruzankin and S. Khrushchev was supported by the program for fundamental scientific research of the Siberian Branch of the Russian Academy of Sciences, project FWNF-2024-0001. The funders had no role in study design, data acquisition and analysis, decision to publish, nor preparation of the manuscript.

PY - 2025/1

Y1 - 2025/1

N2 - OBJECTIVE: To test the hypothesis that levosimendan administration in patients with low cardiac output syndrome after cardiac surgery is associated with improved long-term (5-year follow-up) outcomes.DESIGN: Single-center subanalysis of the multicenter randomized CHEETAH trial.SETTING: Cardiac surgery department of a tertiary hospital.PARTICIPANTS: A total of 134 adult patients requiring hemodynamic support for a cardiac index <2.5 L/min/m 2 after cardiac surgery with cardiopulmonary bypass (CPB). INTERVENTIONS: Patients were randomized (1:1 ratio) to receive levosimendan (continuous infusion with a starting dose of 0.05 μg/kg/min) or placebo, in addition to standard inotropic care.MEASUREMENTS AND MAIN RESULTS: The primary endpoint was long-term mortality (1-5 years) after randomization. Secondary outcomes were hemodynamic parameters, need for inotropic support, acute kidney injury (AKI), need for renal replacement therapy, duration of mechanical ventilation, intensive care unit (ICU) and hospital stay, and 30-day mortality. No significant between-group difference in long-term mortality (5 years) was observed (hazard ratio, 1.59; 95% confidence interval, 0.81 to 3.11; p = 0.17). There were no significant differences in secondary outcomes, except for the difference in the mean pulmonary artery pressure at 4 to 6 hours after randomization, which was lower in the levosimendan group compared to the placebo group (median, 24 [interquartile range (IQR), 21.8-28] mmHg vs 26 [IQR, 22.2-33] mmHg; p = 0.019).CONCLUSIONS: Among patients requiring hemodynamic support after cardiac surgery with CPB, perioperative levosimendan infusion did not affect long-term survival (1-5 years) compared with placebo. Levosimendan also had no effect on major clinical outcomes such as AKI, ICU stay, hospital stay, and 30-day mortality.

AB - OBJECTIVE: To test the hypothesis that levosimendan administration in patients with low cardiac output syndrome after cardiac surgery is associated with improved long-term (5-year follow-up) outcomes.DESIGN: Single-center subanalysis of the multicenter randomized CHEETAH trial.SETTING: Cardiac surgery department of a tertiary hospital.PARTICIPANTS: A total of 134 adult patients requiring hemodynamic support for a cardiac index <2.5 L/min/m 2 after cardiac surgery with cardiopulmonary bypass (CPB). INTERVENTIONS: Patients were randomized (1:1 ratio) to receive levosimendan (continuous infusion with a starting dose of 0.05 μg/kg/min) or placebo, in addition to standard inotropic care.MEASUREMENTS AND MAIN RESULTS: The primary endpoint was long-term mortality (1-5 years) after randomization. Secondary outcomes were hemodynamic parameters, need for inotropic support, acute kidney injury (AKI), need for renal replacement therapy, duration of mechanical ventilation, intensive care unit (ICU) and hospital stay, and 30-day mortality. No significant between-group difference in long-term mortality (5 years) was observed (hazard ratio, 1.59; 95% confidence interval, 0.81 to 3.11; p = 0.17). There were no significant differences in secondary outcomes, except for the difference in the mean pulmonary artery pressure at 4 to 6 hours after randomization, which was lower in the levosimendan group compared to the placebo group (median, 24 [interquartile range (IQR), 21.8-28] mmHg vs 26 [IQR, 22.2-33] mmHg; p = 0.019).CONCLUSIONS: Among patients requiring hemodynamic support after cardiac surgery with CPB, perioperative levosimendan infusion did not affect long-term survival (1-5 years) compared with placebo. Levosimendan also had no effect on major clinical outcomes such as AKI, ICU stay, hospital stay, and 30-day mortality.

KW - cardiac surgery

KW - cardiopulmonary bypass

KW - levosimendan

KW - low cardiac output syndrome

KW - Humans

KW - Simendan/administration & dosage

KW - Cardiac Output, Low/drug therapy

KW - Male

KW - Female

KW - Cardiac Surgical Procedures/adverse effects

KW - Aged

KW - Middle Aged

KW - Cardiotonic Agents/therapeutic use

KW - Postoperative Complications

KW - Pyridazines/therapeutic use

KW - Follow-Up Studies

KW - Hydrazones/therapeutic use

KW - Treatment Outcome

KW - Double-Blind Method

UR - https://www.scopus.com/record/display.uri?eid=2-s2.0-85208051818&origin=inward&txGid=e6006410b8b5c853acda3988d4cd06a9

UR - https://www.mendeley.com/catalogue/f2b6e06f-407c-39a8-9dd1-2199b6536221/

U2 - 10.1053/j.jvca.2024.10.003

DO - 10.1053/j.jvca.2024.10.003

M3 - Article

C2 - 39482169

VL - 39

SP - 151

EP - 161

JO - Journal of Cardiothoracic and Vascular Anesthesia

JF - Journal of Cardiothoracic and Vascular Anesthesia

SN - 1053-0770

IS - 1

ER -