An observational study in Levosimendan, Cardiac Surgery and Heart Failure With Reduced Ejection Fraction, sponsored by Central Hospital, Nancy, France. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-01.
Sponsored by Central Hospital, Nancy, France · Observational
Levosimendan, a drug with inotropic, vasodilatory and myocardial protective properties, has been proposed for the prevention and treatment of postoperative low cardiac output syndrome in cardiac surgery. Despite preliminary studies with promising results, large randomized controlled trials aimed at demonstrating the benefits of levosimendan did not show superiority over placebo in this indication. However, in these studies, the infusion was neither performed at the maximum dosage nor during the 24 hours preceding the surgery, but mainly at the very beginning of the operation. However, post hoc analyses showed a reduction in mortality and in the occurrence of low cardiac output syndrome in the subgroup of patients who had undergone isolated coronary artery bypass grafting, in contrast to those who had undergone valvular or combined surgery. Another recent study suggests that under similar conditions, preconditioning with levosimendan started 48 hours before surgery reduces the length of stay in intensive care and the average cost of hospitalization. There are no formal recommendations on the prophylactic use of levosimendan in cardiac surgery for heart failure patients with impaired LVAS. However, the France-Levo registry, a multicenter observational study requested by the HAS, has shown that in real practice there is a place for preconditioning with levosimendan, which is used in this indication for 7% of the patients in the registry. The Cardiovascular Surgery and Transplantation Department of the Nancy Brabois University Hospital, which actively participated in the France-Levo registry, is one of the cardiac surgery centers that uses this practice, as is the University Hospital of Rouen. It is interesting to be able to evaluate retrospectively whether levosimendan preconditioning has a positive impact on the postoperative prognosis of patients and more particularly on the reduction of the length of stay in critical care and in hospital compared to standard management.
Central Hospital, Nancy, France is the lead sponsor of 797 studies on the registry; 188 are open to participants now.
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Preoperative heart failure patients with impaired LVEF who underwent left heart surgery (coronary artery bypass grafting and/or mitral and/or aortic valve replacement) under extracorporeal circulation from 01/09/2018 to 28/02/2022 at different University Hospital in France
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Exclusion Criteria:
Major patients in heart failure with impaired LVEF (\< 40%) who have undergone left heart surgery (coronary artery bypass grafting and/or mitral and/or aortic valve replacement) under extracorporeal circulation between 01/01/2018 and 28/02/2022 at different French Hospital, and who have received Levosimendan preoperatively
Drug: Levosimendan
Major patients in heart failure with impaired LVEF (\< 40%) who have undergone left heart surgery (coronary artery bypass grafting and/or mitral and/or aortic valve replacement) under extracorporeal circulation between 01/01/2018 and 28/02/2022 at different French Hospital and who have not received Levosimendan preoperatively
Drug: No Levosimendan
Initiation of levosimendan 48 hours before surgery
Also known as: Interventional
Without Levosimendan Infusion
Also known as: Control
Major Adverse Cardiac Events (MACE) criteria at 30 days
to evaluate the impact of preconditioning with Levosimendan prior to scheduled cardiac surgery with extracorporeal circulation in patients with heart failure and impaired LVEF on the rate of cardiovascular events at 30 days post-op.
Time frame: 30 days after Levosimendan exposure
major renal events (MAKE) at 30 days from the date of surgery
to evaluate the impact of preconditioning with Levosimendan prior to scheduled cardiac surgery under extracorporeal circulation in patients with heart failure and impaired LVEF on the rate of renal events at 30 days post cardiac surgery.
Time frame: 30 days after Levosimendan exposure
On 1-year mortality
To evaluate the impact of preconditioning with Levosimendan before cardiac surgery in patients with heart failure and impaired left ventricular dysfunction on 1-year mortality
Time frame: 1 year after Levosimendan exposure
Length of stay in ICU
To evaluate the impact of levosimendan preconditioning preoperatively for cardiac surgery on critical care length of stay in patients with heart failure with impaired preoperative LVAS
Time frame: date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months
the total length of hospital stay
To evaluate the impact of preconditioning with Levosimendan preoperatively for cardiac surgery in patients with heart failure with impaired preoperative left ventricular dysfunction on the total length of hospital stay
Time frame: start date of hospitalization in intensive care to the date of discharge from conventional sectors evaluated up to 3 months
Measurement of left ventricular ejection fraction by cardiac ultrasound at hospital discharge
To evaluate the impact of Levosimendan preconditioning before cardiac surgery in patients with heart failure and impaired on left ventricular systolic function (measured by cardiac ultrasound) at hospital discharge
Time frame: date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months
duration of catecholamine use after surgery
To evaluate the impact of preconditioning with Levosimendan before cardiac surgery in patients with heart failure and impaired left ventricular function before surgery on the duration of catecholamine use after surgery
Time frame: date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months
severity of postcardiotomy cardiogenic shock and/or postoperative vasoplegia using the score Vasoactive Inotropic Score (VIS)
To evaluate the impact of preconditioning with Levosimendan in preoperative cardiac surgery in patients with heart failure with impaired preoperative LVAS on the severity of postcardiotomy cardiogenic shock and/or postoperative vasoplegia. High VIS was empirically defined as ≥ 20. Maximum VIS≥20 predicts an increased likelihood of a poor composite clinical outcome
Time frame: date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months
Plan to share: Undecided
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This study is status unknown, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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