Objective To investigate the stability, safety and efficacy of a new domestic portable nitric oxide (NO) generator in children with pulmonary hypertension after surgery for congenital heart disease.
Methods Children with refractory pulmonary hypertension after congenital heart disease from October 2022 to September 2023 were continuously enrolled in Heart Center of Shanghai Children's Medical Center. Basic information, diagnosis, ventilator parameters, concentration and duration of NO treatment, hemodynamic indexes and biochemical indexes were collected. The stability of the gas concentration of the portable NO generator in the early 24 hours after surgery were evaluated. The concentrations of related gases including nitrogen dioxide and methemoglobin were tested to evaluate the safety. Pulmonary artery pressure, oxygenation index, central venous pressure (CVP), N-terminal pro-B-type natriuretic(NT-proBNP), urine output, serum creatinine before and after NO inhalation therapy were compared to evaluate the effectiveness.
Results Among the 18 children, 8 were males,and 10 were females, with a median,weight of 11.0 (3.4,22.3) kg, a median age of 422.5 (44.0,2 327.3) d, a preoperative percutaneous arterial oxygen saturation (SPO2) of (84.3±11.7)%, 12 cases with biventricular correction, and 6 cases with single ventricular correction. The inhalation treatment time of NO was (95±11.2) h, the concentration of inhaled NO ranged from 3-80 (19±3.5)ppm. The tidal volume on the ventilator was 25-290 ml. The mortality rate was 16.7% in 3 children, and the causes of death were sepsis, right heart failure and multiorgan insufficiency. After inhalation, the mean pulmonary artery pressure decreased significantly [(50.2±20.6) mmHg vs. (28.6±10.5) mmHg, P=0.01), CVP decreased significantly [(15.3±2.1) mmHg vs. (13.8±1.3) mmHg, P<0.01], NT-proBNP decreased significantly [(10 583.9±7 938.4) pg/ml vs. 9 (866.0±7 802.5) pg/ml, P=0.02], and oxygenation index was significantly increased. [(91.4±35.9)% vs. (103.4±39.9)%, P<0.01] The concentration of nitrogen dioxide was (0.1±0.02) ppm, the content of methemoglobin was 0.9±0.6%, and the maximum content was 2.8%. All within the safe range.
Conclusion The NO concentration produced by this domestic portable NO generator is stable, which can significantly reduce the pulmonary artery pressure and central venous pressure in children with pulmonary hypertension refractory to congenital heart disease surgery, significantly improve the oxygenation index with the related products including nitrogen dioxide and methemoglobin within the safe range, which is safe and effective.