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

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

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.

Study Overview

• Status: Completed
• Conditions: Congenital Heart Defect; Right Ventricular Outflow Tract Reconstruction
• Intervention / Treatment: Procedure: right ventricular outflow tract reconstruction with contegra; Procedure: right ventricular outflow tract reconstruction with pulmonary homograft

• Study Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • Hôpital Universitaire des Enfants Reine Fabiola

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients who underwent a right ventricular outflow tract reconstruction between January 1992 and December 2014 at the Hôpital Universitaire des Enfants Reine Fabiola, Belgium

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Contegra patients	Procedure: right ventricular outflow tract reconstruction with contegra; Contegra pulmonary valved conduit is an animal jugular vein that contains a valve with three leaflets that are similar to a human heart valve.
Pulmonary homograft patients	Procedure: right ventricular outflow tract reconstruction with pulmonary homograft; cryopreserved pulmonary homografts

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Queen Fabiola Children's University Hospital
• Investigators: Principal Investigator: Pierre Wauthy, MDPhD, Queen Fabiola Children's University Hospital

Publications and helpful links

General Publications

• Falchetti A, Demanet H, Dessy H, Melot C, Pierrakos C, Wauthy P. Contegra versus pulmonary homograft for right ventricular outflow tract reconstruction in newborns. Cardiol Young. 2019 Apr;29(4):505-510. doi: 10.1017/S1047951119000143. Epub 2019 Apr 3.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): October 30, 2017

Study Registration Dates

• First Submitted: November 16, 2017
• First Submitted That Met QC Criteria: November 16, 2017
• First Posted (Actual): November 20, 2017

Study Record Updates

• Last Update Posted (Actual): November 20, 2017
• Last Update Submitted That Met QC Criteria: November 16, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital
• Other Study ID Numbers: P2016/Cardio/RVOTtherapy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No