OBJECTIVE
To compare the outcomes of palliative right ventricular outflow tract repair without ventricular septal defect closure by allogeneic vein valved allograft with the modified Blalock-Taussig shunt in the treatment of patients with pulmonary artery atresia and ventricular septal defect.
MATERIAL AND METHODS
A pilot randomized trial enrolled 24 consecutive patients with pulmonary atresia and ventricular septal defect who underwent palliative procedures. Patients were randomized into two groups depending on the type of surgery: right ventricular outflow tract reconstruction without ventricular septal defect closure by allogeneic vein valved allograft (I group, 12 patients) or the modified Blalock-Taussig shunt (II group, 12 patients). Primary endpoint was pulmonary artery growing (index Nakata) in 6 months after palliative surgery. Secondary endpoints were early and mid-term postoperative morbidity, pulmonary artery deformations, redo surgery, mortality, time from palliative surgery to complete repair.
RESULTS
In-hospital mortality was 0% in I group and 9.1% in II group (p=0.452). Pulmonary artery deformation was observed in 5 patients in group I and 4 patients in group II (p=0.076). Oxygen saturation after 6 months was 87.2% (82.1; 92.4) in group I and 76.1% (73; 79.2) in group II (p=0.001). Nakata index in 6 months after palliative sure surgery was 272.1 mm2/m2 (244.9; 296.8) in group I and 239.1 mm2/m2 (191.8; 274.4) in group II (p=0.035). There was no significant between-group differences in early mortality and complication rate (p=0.063).
CONCLUSION
Palliative right ventricular outflow tract reconstruction without ventricular septal defect closure by allogeneic vein valved allograft ensures better pulmonary artery growth in comparison with the modified Blalock-Taussig shunt (p=0.035) without significant between-group differences in clinical outcomes.