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Durability of tissue-engineered bovine pericardium (CardioCel®) for a minimum of 24 months when used for the repair of congenital heart defects.
Interactive Cardiovascular and Thoracic Surgery 2019 Februrary 2
OBJECTIVES: This study aims to assess the performance of tissue-engineered bovine pericardium (CardioCel®) at 24 months and beyond when used for the repair of congenital heart defects.
METHODS: Between October 2012 and November 2014, CardioCel was implanted in 135 patients (140 procedures and 195 implants). Applications included the closure of septal defects (98, 50.3%), repair of pulmonary arteries (63, 32.3%), intra-atrial/intraventricular baffles (10, 5.1%), repair of systemic arteries (15, 7.7%), valve repair (5, 2.6%), repair of systemic veins (3, 1.5%) and Fontan operation (1, 0.5%). There were 19 (13.6%) procedures performed in neonates, 77 (55%) in infants and 44 (31.4%) in children older than 365 days.
RESULTS: Eight patients (n = 135, 5.9%) required reintervention in 12 instances (n = 195, 6.2%, 6 catheters and 6 surgical). There was no echocardiographic or radiological evidence of calcification in any patient. Ten of the reinterventions (83%) occurred within the first 12 months. All the reinterventions occurred within 36 months. Freedom from reintervention at both 12 and 24 months was 95% [confidence interval (CI) 91-97] and at 36 months was 94% (CI 89-97). There was no statistical difference in freedom from reintervention when stratified by age or patch position.
CONCLUSIONS: At 24 months and beyond the follow-up, the performance of CardioCel remains acceptable with good haemodynamic performance. There was no echocardiographic or radiological evidence of calcification in any patient. CardioCel performs comparably in systemic and pulmonary circulations.
METHODS: Between October 2012 and November 2014, CardioCel was implanted in 135 patients (140 procedures and 195 implants). Applications included the closure of septal defects (98, 50.3%), repair of pulmonary arteries (63, 32.3%), intra-atrial/intraventricular baffles (10, 5.1%), repair of systemic arteries (15, 7.7%), valve repair (5, 2.6%), repair of systemic veins (3, 1.5%) and Fontan operation (1, 0.5%). There were 19 (13.6%) procedures performed in neonates, 77 (55%) in infants and 44 (31.4%) in children older than 365 days.
RESULTS: Eight patients (n = 135, 5.9%) required reintervention in 12 instances (n = 195, 6.2%, 6 catheters and 6 surgical). There was no echocardiographic or radiological evidence of calcification in any patient. Ten of the reinterventions (83%) occurred within the first 12 months. All the reinterventions occurred within 36 months. Freedom from reintervention at both 12 and 24 months was 95% [confidence interval (CI) 91-97] and at 36 months was 94% (CI 89-97). There was no statistical difference in freedom from reintervention when stratified by age or patch position.
CONCLUSIONS: At 24 months and beyond the follow-up, the performance of CardioCel remains acceptable with good haemodynamic performance. There was no echocardiographic or radiological evidence of calcification in any patient. CardioCel performs comparably in systemic and pulmonary circulations.
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