Real-world safety and effectiveness of inhaled nitric oxide therapy for pulmonary hypertension during the perioperative period of cardiac surgery: a post-marketing study of 2817 patients in Japan

Figures

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  Fig. 1. Patient flow diagram, aPatients were excluded if they received perioperative INOflo during procedures other than cardiac surgery, or if cardiac surgery could not be ascertained from case reports forms. CRF case report form, NO nitric oxide

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  Fig. 2. Mean (a) blood MetHb concentration and (b) inspired NO2 concentration over time in pediatric and adult patients who received INOflo for pulmonary hypertension during the perioperative period of cardiac surgery (safety analysis population) Analyses are based on observed data, with no imputation for missing values. Error bars present SD. MetHb methemoglobin, NO2 nitrogen dioxide, SD standard deviation

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  Fig. 3. Mean change in (a) CVP among pediatrics and (b) mPAP among adults who received INOflo for pulmonary hypertension during the perioperative period of cardiac surgery (effectiveness analysis population) Analyses are based on observed data, with no imputation for missing values. Error bars present 95% CI; p-values were calculated using paired t-tests. CI confidence interval, CVP central venous pressure, mPAP mean pulmonary arterial pressure

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  Fig. 4. Mean change in PaO2/FiO2 ratio by baseline PaO2/FiO2 in (a) pediatric and (b) adult patients who received INOflo for pulmonary hypertension during the perioperative period of cardiac surgery (effectiveness analysis population) Solid bars present change in PaO2/FiO2 from baseline at 24 h after iINOflo initiation; striped bars present change in PaO2/FiO2 from baseline at treatment completion/withdrawal. Analyses are based on observed data, with no imputation for missing values. Error bars present 95% CI; p-values were calculated using paired t-tests CI confidence interval, FiO2 fraction of inspired oxygen, PaO2 partial pressure of arterial oxygen