Clinical Assessment of Perfusion Techniques During Surgical Repair of Coarctation of Aorta With Aortic Arch Hypoplasia in Neonates: A Pilot Prospective Randomized Study.

We aimed to compare the safety and efficacy of 3 perfusion methods primarily used in aortic arch reconstruction in infants, namely, deep hypothermic circulatory arrest, selective antegrade cerebral perfusion, and double arterial cannulation. Forty-five infants with aortic arch obstruction and biventricular anatomy were enrolled in this pilot prospective study (ClinicalTrials.gov registration number: NCT02835703). Patients were randomly assigned into 3 groups according to the perfusion strategy (deep hypothermic circulatory arrest, n = 15; selective antegrade cerebral perfusion, n = 15; double arterial cannulation, n = 15). The primary composite endpoint was the incidence of adverse events in the early postoperative period (acute kidney injury [KDIGO criteria], new brain magnetic resonance imaging (MRI) findings, and in-hospital mortality). The secondary endpoints were intensive care unit length of stay, vasoactive-inotropic score index, and cardiopulmonary bypass duration. All patients underwent aortic arch reconstruction under cardiopulmonary bypass and were monitored with near-infrared spectroscopy during surgery. No significant differences in the baseline characteristics and cardiopulmonary bypass duration were observed among the groups. The incidence of unfavorable events was lower in the double arterial cannulation group (P = 0.041). Acute kidney injury was observed in 8, 6, and 5 patients from the deep hypothermic circulatory arrest, selective antegrade cerebral perfusion, and double arterial cannulation groups, respectively (P = 0.64). Twelve patients from the deep hypothermic circulatory arrest group had new brain MRI findings (P = 0.019). There were 5 in-hospital deaths with no significant difference among the groups (P = 0.70). The "head" and "lumbar" values on near-infrared spectroscopy during aortic arch reconstruction were significantly higher in the selective antegrade cerebral perfusion and double arterial cannulation groups than in the deep hypothermic circulatory arrest group. Patients in the double arterial cannulation group had a significantly lower vasoactive-inotropic score index 24 hours postoperatively than the deep hypothermic circulatory arrest group (P = 0.03). Vasoactive-inotropic score index >12 was found to be a risk factor for acute kidney injury and early mortality. Continuous regional perfusion during aortic arch reconstruction decreases the risk of new brain MRI findings in infants and the need for postoperative inotropic support. Although values of near-infrared spectroscopy during the procedure were significantly higher with continuous perfusion strategies, these methods do not reduce the acute kidney injury incidence compared to that with deep hypothermic circulatory arrest. Double arterial cannulation significantly reduces the need for inotropic support.

RCT Entities:   Population Interventions Outcomes