Contegra Versus Pulmonary Homograft for Right Ventricular Outflow Tract Reconstruction in Newborns

Study Overview
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Brief Summary
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Pulmonary homografts are standard substitutes for right ventricular outflow tract reconstruction in congenital heart surgery. Unfortunately shortage and conduit failure secondary to early calcifications and shrinking are observed particularly for small sized conduits in younger patients. In neonates, Contegra® 12mm could be a valuable alternative, but conflicting evidence exists. This retrospective study compared the outcome of these two conduits in a newborn population.

Official Title
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Contegra Versus Pulmonary Homograft for Right Ventricular Outflow Tract Reconstruction in Newborns : Fifteen Years' Experience

Conditions
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Congenital Heart Defect, Right Ventricular Outflow Tract Reconstruction

Intervention / Treatment
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* Procedure: right ventricular outflow tract reconstruction with contegra
* Procedure: right ventricular outflow tract reconstruction with pulmonary homograft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: neonatal patients who had a reconstruction of the right ventricular outflow tract with a pulmonary homograft or a Contegra between January 1992 and December 2014 at HUDERF Exclusion Criteria: NA

Ages Eligible for Study
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Maximum Age: 30 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Contegra patients<br> | Procedure: right ventricular outflow tract reconstruction with contegra<br>* Contegra pulmonary valved conduit is an animal jugular vein that contains a valve with three leaflets that are similar to a human heart valve.<br>|
| Pulmonary homograft patients<br> | Procedure: right ventricular outflow tract reconstruction with pulmonary homograft<br>* cryopreserved pulmonary homografts<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of mid term course between pediatric right ventricular outflow tract recontruction with homograft and contegra |  | up to 195 months post right ventricular outflow tract recontruction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of early conduit-related reintervention according to the Nakata index |  | up to 195 months post right ventricular outflow tract recontruction | 
| Proportion of early conduit-related reintervention according to the congenital heart defect diagnosis |  | up to 195 months post right ventricular outflow tract recontruction | 
| Proportion of early conduit-related reintervention in right ventricular outflow tract recontructed with contegra |  | up to 195 months post right ventricular outflow tract recontruction | 
| Proportion of early conduit-related reintervention in right ventricular outflow tract recontructed with pulmonary homograft |  | up to 195 months post right ventricular outflow tract recontruction | 
| Overal mortality in right ventricular outflow tract recontructed with contegra |  | up to 195 months post right ventricular outflow tract recontruction | 
| Overal mortality in right ventricular outflow tract recontructed with pulmonary homograft |  | up to 195 months post right ventricular outflow tract recontruction | 
| Residual pulmonary arterial hypertension rate in right ventricular outflow tract recontructed with contegra |  | up to 195 months post right ventricular outflow tract recontruction | 
| Residual pulmonary arterial hypertension rate in right ventricular outflow tract recontructed with pulmonary homograft |  | up to 195 months post right ventricular outflow tract recontruction |