CLINICAL TRIAL
JOURNAL ARTICLE
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Adverse mid-term outcome following RVOT reconstruction using the Contegra valved bovine jugular vein.

BACKGROUND: Current techniques for repair of the right ventricular outflow tract (RVOT) may require interposition of a valved conduit between the right ventricle and the pulmonary artery bifurcation. Recently, the Contegra conduit (Medtronic, Inc.) was introduced as an alternative xenograft tissue for RVOT reconstruction. Promising early hemodynamic and clinical results have been reported so far, but still less is known about mid-term adverse outcome.

METHODS: A total of 38 Contegra valved conduits (12 to 22 mm) were implanted from October 1999 to June 2004, in 36 children less than 5 years old and in 2 patients 8 and 21 years old. Diagnosis included the following: tetralogy of Fallot (n = 21); pulmonary atresia (n = 4); double outlet right ventricle + pulmonary stenosis (n = 3); d-transposition of the great arteries, ventricular septal defect, and pulmonary stenosis (n = 3); truncus arteriosus (n = 3); and other complex malformations (n = 4).

RESULTS: There was no mortality following initial surgery and no valved-conduit-related early morbidity. Early postoperative echocardiographic assessment after 3 months demonstrated favorable hemodynamics in all patients. However, during further follow-up, 5 conduits had to be replaced because of severe stenosis at the level of the distal anastomosis (2 of them had moderate to severe dilatation of the conduit proximally to the valve). Excessive intimal peel formation and severe perigraft scarring reaction were observed in all cases. One child died before surgery.

CONCLUSIONS: The Contegra valved conduit is an interesting concept for reconstruction of the RVOT. However, because of unpredictable incidence of supravalvar stenosis during mid-term results, we cannot recommend routine use of this material.

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