Surgery for congenital valve anomalies in children is a challenging topic. We aim to assess early and late functional outcomes of CorMatrix scaffold after repair of aortic and pulmonary valves (PV) in congenital heart disease in a prospective nonrandomized clinical study on children with congenital aortic (Group 1) or PV (Group 2) disease. Primary endpoints were reoperation or reintervention on semilunar valves and echocardiographic evidence of regurgitation or stenosis greater than mild. Results of PV repair in tetralogy of Fallot were compared with a control group of patients who underwent PV repair with polytetrafluoroethylene. A total of 22 consecutive selected patients with complex congenital heart disease were included: PV repair in 18 and aortic valve repair in 4. At discharge bidimensional echocardiography, semilunar valve regurgitation was mild in 50% of all patients. At a median follow-up of 23 months (4.3-51.3), reoperation for aortic valve replacement was necessary in 2; right ventricular outflow tract obstruction occurred in 3, requiring interventional treatment in 2. Pulmonary regurgitation degree worsened in most patients of Group 2 at follow up. When comparing patients with tetralogy of Fallot in Group 2 with patients who underwent PV repair with polytetrafluoroethylene, there were no significant differences in PV function at follow up. We conclude that CorMatrix scaffold for semilunar valve reconstruction does not present with significant advantages to traditional materials at mid term follow up. In addition, when used for pulmonary valve reconstruction, CorMatrix seems to show gradual functional deterioration in the mid term.
Keywords: Congenital heart disease; ECM (extracellular matrix); Outcomes; SIS (small intestine submucosa); Scaffold; Semilunar valve surgery.
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