MULTICENTER STUDY
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The Contegra bovine valved jugular vein conduit for pediatric RVOT reconstruction: 4 years experience with 108 patients.

BACKGROUND: Porcine xenografts for pediatric right ventricular outflow tractus (RVOT) reconstruction lack durability, homografts lack availability. The Contegra is a valve bearing bovine jugular vein. It is tear resistant, well pliable, and permits RVOT reconstruction without further foreign material. The 108 Contegras implanted in Bad Oeynhausen from May 1999 until January 2003 represent the largest single-center Contegra experience. The study gives the preliminary results from a controlled prospective multicenter trial aiming at FDA admission.

METHODS: The patients' diagnoses were truncus arteriosus (27%), double outlet right ventricle (14%), tetralogy of Fallot (48%), transposition of great arteries (6%), rare complex malformation (2%), and Ross procedure (1%). Fifty-eight were female. Age: 2 days to 20.1 years, mean: 4.3 +/- 5.2, median: 1.8 years. Thirty-three had primary implantations, 38 previous repairs, 37 conduit exchange. Total follow-up time: 227.7 years, mean: 2.1. About 848 echos were evaluated.

RESULTS: Early mortality: 7.4% (8 patients); 1 late death. None was Contegra-related. Echocardiographic controls showed no relevant average valvular gradient development. Trace and mild-grade insufficiency is frequent, without tendency to increase. Average insufficiency is between trace and mild unless RV pressure remains under 100 mmHg. Average individual right/left ventricle length ratios did not increase over time. We saw no relevant conduit dilatation and no leaflet calcification. Pulmonary artery stenoses had mainly extrinsic reasons. At 4 years, freedom- from- event rates were: reoperation for Conduit inflow or valvular degeneration: 100%; reoperation for pulmonary artery branch stenoses (n = 10) 86%, explantation (n = 4): 92%. Survival: 91.7%.

CONCLUSION: Contegra is worth being considered as an alternative to homografts.

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