Key result
Low-dose inhaled iloprost significantly increased the achievement of the combined clinical endpoint compared to placebo (6 patients vs 0 patients; P=0.005) in children after congenital heart surgery.
Why the study?
Does inhaled iloprost improve hemodynamics and prevent pulmonary hypertensive crises in children with pulmonary hypertension following surgery to correct congenital heart disease?
RCT (n=22)
Randomized
Does inhaled iloprost improve hemodynamics and prevent pulmonary hypertensive crises in children with pulmonary hypertension following surgery to correct congenital heart disease?
p-value: p=0.005
Inhaled iloprost, particularly at a low dose, significantly improves hemodynamics and helps prevent pulmonary hypertensive crises in children following surgery for congenital heart disease.
Low-dose inhaled iloprost met the primary hemodynamic endpoint post-CHD surgery; extends scarce pediatric RCT data and supports targeted use pending larger trials.
Congenital heart disease (CHD) can cause pulmonary hypertension (PH) in children, and surgery to correct CHD may be complicated by postoperative pulmonary hypertensive crises (PHC). Clinical data regarding the use of inhaled iloprost to treat children with PH are scarce. Our aim was to determine the efficacy and safety of iloprost in children with PH following surgery to correct CHD. This was a randomized, placebo-controlled study of 22 children (median age 7 months) undergoing surgery to achieve biventricular repair. The combined clinical endpoint was a decrease of more than 20% in the ratio of systolic pulmonary arterial pressure to systolic arterial pressure or pulmonary resistance to systemic resistance, with no PHC or death. Patients were randomized to receive low-dose iloprost (30 ng/kg/min), high-dose iloprost (50 ng/kg/min), or placebo, for 10 min every 2 hr in the first 48 hr after surgery. PHC were experienced by two patients who received placebo and one patient treated with high-dose iloprost. The combined clinical endpoint was reached by six patients administered low-dose iloprost (P = 0.005) and four administered high-dose iloprost (P = 0.077), compared with none in the placebo group. Patients treated with iloprost showed a significant reduction from baseline in mean pulmonary vascular resistance index (-2.2 Wood units, P < 0.05), whereas patients who received placebo showed no significant change. This study supports the use of iloprost to treat children with PH following surgery to correct CHD.
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Xu et al. (2014) conducted an RCT in Pulmonary hypertension following surgery to correct congenital heart disease (n=22). Inhaled iloprost vs. Placebo was evaluated on Decrease of more than 20% in the ratio of systolic pulmonary arterial pressure to systolic arterial pressure or pulmonary resistance to systemic resistance, with no pulmonary hypertensive crisis or death (p=0.005). Low-dose inhaled iloprost significantly increased the achievement of the combined clinical endpoint compared to placebo (6 patients vs 0 patients; P=0.005) in children after congenital heart surgery.
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