Prophylactic levosimendan for the prevention of low cardiac output syndrome and mortality in paediatric patients undergoing surgery for congenital heart disease

Johanna Hummel; Gerta Rücker; Brigitte Stiller

doi:10.1002/14651858.CD011312.pub3

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Figure 1

Study flow diagram.

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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Figure 4

Forest plot of comparison: 1 Mortality, outcome: 1.1 Mortality.

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Figure 5

Forest plot of comparison: 2 Low cardiac output syndrome (LCOS), outcome: 2.1 LCOS.

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Analysis 1.1

Comparison 1 Mortality, Outcome 1 Mortality.

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Analysis 2.1

Comparison 2 Low cardiac output syndrome (LCOS), Outcome 1 LCOS.

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Analysis 3.1

Comparison 3 Length of ICU stay, Outcome 1 Length of ICU stay (days).

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Analysis 3.2

Comparison 3 Length of ICU stay, Outcome 2 Length of ICU stay (days).

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Analysis 4.1

Comparison 4 Length of hospital stay, Outcome 1 Length of hospital stay (days).

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Analysis 5.1

Comparison 5 Duration of mechanical ventilation, Outcome 1 Duration of mechanical ventilation (days).

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Analysis 5.2

Comparison 5 Duration of mechanical ventilation, Outcome 2 Duration of mechanical ventilation (days).

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Analysis 6.1

Comparison 6 Mechanical circulatory support or cardiac transplantation, Outcome 1 Mechanical circulatory support or cardiac transplantation.

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Summary of findings for the main comparison. Prophylactic levosimendan compared to standard treatment in children having undergone heart surgery

Prophylactic levosimendan compared to standard treatment in children following heart surgery
Patient or population: paediatric patients following heart surgery Setting: institutions providing postoperative care after heart surgery for congenital heart disease Intervention: levosimendan Comparison: standard inotropes
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with standard inotropes	Risk with levosimendan
Mortality follow‐up: range 1 day to 6 days	Study population		RR 0.47 (0.12 to 1.82)	123 (3 RCTs)	⊕⊕⊝⊝ LOW ^{1, 2}
	57 per 1000	27 per 1000 (7 to 104)
Low cardiac output syndrome (LCOS) follow‐up: range 1 day to 6 days	Study population		RR 0.64 (0.39 to 1.04)	83 (2 RCTs)	⊕⊕⊝⊝ LOW ^{1, 3}
	367 per 1000	235 per 1000 (143 to 381)
Length of intensive care unit stay (Length of ICU stay) follow‐up: range 1 day to 6 days	The mean length of stay in the ICU in the control groups ranged from 2.05 to 11 days	The mean length of stay in ICU in the intervention groups was 0.33 days higher (1.16 lower to 1.82 higher)	‐	188 (4 RCTs)	⊕⊕⊝⊝ LOW ^{1, 4}
Length of hospital stay follow‐up: range 1 day to 6 days	The mean length of hospital stay in the control groups ranged from 15 to 15.8 days	The mean length of hospital stay in the intervention groups was 0.26 days higher (3.50 lower to 4.03 higher)	‐	75 (2 RCTs)	⊕⊕⊝⊝ LOW ^{1, 2}
Duration of mechanical ventilation follow‐up: range 1 day to 6 days	The mean duration of mechanical ventilation in the control groups ranged from 0.29 to 6.5 days	The mean duration of mechanical ventilation in the intervention groups was 0.04 days lower (0.08 lower to 0.00 higher)	‐	208 (5 RCTs)	⊕⊕⊝⊝ LOW ^{1, 4}
Mechanical circulatory support or cardiac transplantation follow‐up: range 1 day to 6 days	Study population		RR 1.49 (0.19 to 11.37)	60 (2 RCTs)	⊕⊕⊝⊝ LOW ^{1, 2}
	10 per 1000	14 per 1000 (2 to 108)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; OR: Odds ratio; MD: mean difference.
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ Downgraded for imprecision due to small sample size. ² Downgraded for imprecision due to few number of events (less than 300). ³ Detection of outcome potentially dependent on study personnel: risk of detection bias in two studies due to unblinded setting. ⁴ Considerable inconsistency between study results.

Summary of findings for the main comparison. Prophylactic levosimendan compared to standard treatment in children having undergone heart surgery

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Comparison 1. Mortality

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Mortality Show forest plot	3	123	Risk Ratio (M‐H, Random, 95% CI)	0.47 [0.12, 1.82]

Comparison 1. Mortality

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Comparison 2. Low cardiac output syndrome (LCOS)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 LCOS Show forest plot	2	83	Risk Ratio (M‐H, Random, 95% CI)	0.64 [0.39, 1.04]

Comparison 2. Low cardiac output syndrome (LCOS)

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Comparison 3. Length of ICU stay

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Length of ICU stay (days) Show forest plot	4	188	Mean Difference (IV, Random, 95% CI)	0.33 [‐1.16, 1.82]

2 Length of ICU stay (days) Show forest plot	4	188	Std. Mean Difference (IV, Random, 95% CI)	‐0.05 [‐0.54, 0.44]

Comparison 3. Length of ICU stay

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Comparison 4. Length of hospital stay

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Length of hospital stay (days) Show forest plot	2	75	Mean Difference (IV, Random, 95% CI)	0.26 [‐3.50, 4.03]

Comparison 4. Length of hospital stay

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Comparison 5. Duration of mechanical ventilation

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Duration of mechanical ventilation (days) Show forest plot	5	208	Mean Difference (IV, Random, 95% CI)	‐0.04 [‐0.08, 0.00]

2 Duration of mechanical ventilation (days) Show forest plot	5	208	Std. Mean Difference (IV, Random, 95% CI)	‐0.08 [‐0.43, 0.27]

Comparison 5. Duration of mechanical ventilation

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Comparison 6. Mechanical circulatory support or cardiac transplantation

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Mechanical circulatory support or cardiac transplantation Show forest plot	2	60	Risk Ratio (M‐H, Random, 95% CI)	1.49 [0.19, 11.37]

Comparison 6. Mechanical circulatory support or cardiac transplantation

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