Key result
In newborns undergoing right ventricular outflow tract reconstruction, Contegra 12 mm resulted in similar overall mortality compared to small pulmonary homografts (16.6% vs 17.4%; p=0.98).
Why the study?
Small-sized pulmonary homografts face shortages and early failure in young patients, and conflicting evidence exists regarding the Contegra 12 mm conduit in newborns with heterogeneous pathologies.
Does Contegra 12 mm improve outcomes compared to small pulmonary homografts in newborns undergoing right ventricular outflow tract reconstruction?
Cohort (n=53)
No
Does Contegra 12 mm improve outcomes compared to small pulmonary homografts in newborns undergoing right ventricular outflow tract reconstruction?
Absolute Event Rate: 16.6% vs 17.4%
p-value: p=0.98
Contegra 12 mm is a valid alternative to small pulmonary homografts for right ventricular outflow tract reconstruction in newborns, with comparable mortality and re-operation rates.
OBJECTIVES: Pulmonary homografts are standard alternatives to right ventricular outflow tract reconstruction in congenital heart surgery. Unfortunately, shortage and conduit failure by early calcifications and shrinking are observed for small-sized homografts in younger patients. In neonates, Contegra® 12 mm (Medtronic Inc., Minneapolis, Minnesota, United States of America) could be a valuable alternative, but conflicting evidence exists. There is no published study considering only newborns with heterogeneous pathologies. We retrospectively compared the outcomes of these two conduits in this challenging population. METHODS: Patients who underwent a right ventricular outflow tract reconstruction between January 1992 and December 2014 at the Hôpital Universitaire des Enfants Reine Fabiola were included. We retrospectively collected and analysed demographic, echocardiographic, surgical, and follow-up data. RESULTS: Of the 53 newborns who benefited from a right ventricular outflow tract reconstruction during the considered period, 30 received a Contegra 12 mm (mean age 15 ± 8 days), and 23 a small (9-14 mm) pulmonary homograft (mean age 10 ± 7 days). Overall mortality was 16.6% with Contegra versus 17.4% in the pulmonary homograft group (p = 0.98 log-rank). Operative morbidity and early re-operation for conduit failure were not significantly different between the two groups. Mean follow-up in this study is 121 ± 74 months. Survival free from re-operation was not different between the two groups (p = 0.15). Multivariable analysis showed that weight and significant early gradient were factors associated with anticipated conduit failure. CONCLUSIONS: Contegra 12 mm is a valid alternative to small pulmonary homografts in a newborn patient population. TRIAL REGISTRATION: NCT03348397.
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Falchetti et al. (2019) conducted a cohort in Congenital heart disease requiring right ventricular outflow tract reconstruction (n=53). Contegra 12 mm vs. Small (9-14 mm) pulmonary homograft was evaluated on Overall mortality (p=0.98). In newborns undergoing right ventricular outflow tract reconstruction, Contegra 12 mm resulted in similar overall mortality compared to small pulmonary homografts (16.6% vs 17.4%; p=0.98).
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