The effect of sildenafil on maternal mortality and fetal adverse outcomes among pregnant patients with congenital heart disease-associated pulmonary artery hypertension: A retrospective cohort study

Maternal and fetal mortality in patients with congenital heart disease-associated pulmonary artery hypertension (CHD-PAH) is reported to be quite high. Sildenafil is the standard of care in PAH. Studies on sildenafil in maternal and fetal clinical outcomes are few. This study aimed to determine the effect of oral sildenafil on the clinical outcomes of mothers and fetuses with CHD-PAH. This study was an observational study with a retrospective cohort method. Patient data were taken from the hospital registry and medical records of patients who met the research criteria from August 2015 to August 2022. Based on sildenafil treatment, subjects were divided into two groups: subjects with oral sildenafil and those without sildenafil. The research outcome was maternal mortality and a composite of fetal adverse outcomes, defined as fetal mortality, oligohydramnios, intrauterine growth retardation (IUGR), and small for gestational age. There were 68 pregnant women who met research criteria, consisting of subjects with sildenafil ( n = 32) and without sildenafil ( n = 36). A composite of maternal and fetal adverse outcomes occurred in 24 subjects (35.3%). Subjects with oral sildenafil therapy were not associated with maternal mortality. Subjects with oral sildenafil therapy had a lower incidence of fetal adverse outcomes ( n = 7, 21.9%) as compared to those without sildenafil ( n = 25, 56.8%), P = 0.029. In the multivariate analysis, oral sildenafil therapy had a neutral impact on maternal mortality and fetal adverse outcomes. Other PAH therapy use was a significant independent predictor of maternal mortality. The PVR value was a significant independent predictor of fetal adverse outcomes. Oral sildenafil therapy was safe for pregnant CHD-associated PAH patients. Oral sildenafil therapy reduced fetal adverse outcomes, namely fetal mortality, oligohydramnios, fetal growth restriction, and small for gestational age infants, in patients with CHD-associated PAH. PAH severity had a significant impact on pregnancy outcome.