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Levosimendan versus milrinone in neonates and infants after corrective open-heart surgery: a pilot study
Evelyn Lechner1, Anna Hofer, Gabriele Leitner-Peneder
1Department of Neonatology, Children's and Maternity Hospital, Linz, Austria. elechner@aon.at
Insights
Prophylactic levosimendan and milrinone showed similar cardiac index post-pediatric heart surgery. Levosimendan increased cardiac output over time, while milrinone maintained stable levels in this pilot study.
Area of Science:
- Pediatric Cardiology
- Cardiovascular Pharmacology
Background:
- Low cardiac output syndrome is a common complication after pediatric open-heart surgery.
- Prophylactic milrinone is frequently used to prevent low cardiac output syndrome in infants post-cardiopulmonary bypass.
Purpose of the Study:
- To compare the effects of prophylactically administered levosimendan versus milrinone on cardiac index in neonates and infants following corrective open-heart surgery.
Main Methods:
- A prospective, single-center, double-blind, randomized pilot study involving 40 infants undergoing corrective open-heart surgery.
- Patients received either a 24-hour infusion of levosimendan (0.1 μg/kg/min) or milrinone (0.5 μg/kg/min) after cardiopulmonary bypass.
- Cardiac output and cardiac index were monitored using transesophageal Doppler at multiple time points up to 48 hours post-surgery.
Main Results:
- Analysis of variance revealed no significant differences in cardiac index or cardiac output between the levosimendan and milrinone groups over time.
- A significant interaction indicated different time courses for cardiac output and index, with levosimendan showing an increase and milrinone showing stability.
- Both drugs were well-tolerated, with no reported deaths or serious adverse events.
Conclusions:
- Prophylactic levosimendan and milrinone resulted in similar postoperative cardiac index in neonates and infants after open-heart surgery.
- Levosimendan demonstrated a trend towards increasing cardiac output and index over time, unlike milrinone.
- This pilot study provides valuable experience with levosimendan in pediatric patients and supports further multicenter trials.
Objective:
Low cardiac output syndrome commonly complicates the postoperative course after open-heart surgery in children. To prevent low cardiac output syndrome, prophylactic administration of milrinone after cardiopulmonary bypass is commonly used in small children. The aim of this study was to compare the effect of prophylactically administered levosimendan and milrinone on cardiac index in neonates and infants after corrective open-heart surgery.
Design:
Prospective, single-center, double-blind, randomized pilot study.
Setting:
Tertiary care center, postoperative pediatric cardiac intensive care unit.
Patients:
After written informed consent, 40 infants undergoing corrective open-heart surgery were included.
Interventions:
At weaning from cardiopulmonary bypass, either a 24-hr infusion of 0.1 μg/kg/min levosimendan or of 0.5 μg/kg/min milrinone were administered. Cardiac output was evaluated at 2, 6, 9, 12, 18, 24, and 48 hrs after cardiopulmonary bypass using a transesophageal Doppler technique (Cardio-QP, Deltex Medical, Chichester, UK). Cardiac index was calculated from cardiac output and the patients' respective body surface area.
Results:
Intention-to-treat data of 39 patients (19 in the levosimendan and 20 in the milrinone group) were analyzed using analysis of variance for repeated measurements for statistics. Analysis of variance revealed for both, cardiac index and cardiac output, similar results with no significant differences of the factors group and time. A significant interaction for cardiac output (p = .005) and cardiac index (p = .007) was found, which indicates different time courses of cardiac index in the two groups. Both drugs were well tolerated; no death or serious adverse event occurred.
Conclusions:
In our small study, postoperative cardiac index over time was similar in patients with prophylactically administered levosimendan and patients with prophylactically given milrinone. We observed an increase in cardiac output and cardiac index over time in the levosimendan group, whereas cardiac output and cardiac index remained stable in the milrinone group. This pilot study has primarily served to obtain experience using the new drug levosimendan in neonates and infants and to initiate further multicenter trials in pediatric patients.
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