Evolution of Two Cohorts of Children (Univentricular and Bi-ventricular Heart) After Strapping of the Pulmonary Artery

Completed

• Conditions: Congenital Heart Malformations
• Interventions: Other: Retrospective data extraction in medical files

• Registration Number: NCT03047343
• Lead Sponsor: Pierre Wauthy

Brief Summary

Pulmonary artery strapping is a surgical technique aimed at providing a palliative treatment to newborns suffering from congenital heart defects, characterized by an increase in blood flow and pulmonary blood pressure.

The intervention consists of placing a band around the pulmonary artery. This band causes an artificial stenosis, therefore inducing a reduction of the pulmonary arterial pressure. It acts as a first step, preparing the ground for a future definitive repair intervention.

It is mainly used in the context of septal defects, atrio-ventricular canal defects or uni-ventricular hearts.

The complications linked to strapping include, among others, the erosion of the band in the artery lumen, its migration and the obstruction of the pulmonary artery, a pulmonary valvular insufficiency, the obstruction of the coronary artery and an ineffective strapping.

The early mortality rate of pulmonary artery strapping after 1980 varies between 1.8% and 13.6%, while strapping readjustment rates oscillate around 20%. It is assumed that the mortality is linked to the nature of the cardial malformation (uni-ventricular or bi-ventricular) rather than the procedure itself.

This retrospective study aims to evaluate the intra-hospital and extra-hospital mortality rate of pulmonary artery strapping, as well as the readjustment rate within two groups of patients: those benefiting from an uni-ventricular cardiac reparation and those benefiting from a bi-ventricular cardiac reparation. The aim is to determine the short term mortality rate of the intervention and the incidence of complications within the hospital, within the two groups.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-07
• Study First Submitted QC: 2017-02-07
• Study First Posted: 2017-02-08
• Study Start: 2017-03-01
• Status Verified: 2018-05
• Primary Completion: 2018-05-29
• Study Completion: 2018-05-29
• Last Update Submitted: 2018-05-30
• Last Update Posted: 2018-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

• All patients treated with pulmonary artery strapping between 2005 and 2016 at the Queen Fabiola Children Hospital

Exclusion Criteria

• Outdated indications

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bi-ventricular reparation	Retrospective data extraction in medical files	All patients treated with pulmonary artery strapping between 2005 and 2016 at the Queen Fabiola Children Hospital. Patients benefiting from an bi-ventricular reparation.
Uni-ventricular reparation	Retrospective data extraction in medical files	All patients treated with pulmonary artery strapping between 2005 and 2016 at the Queen Fabiola Children Hospital. Patients benefiting from an uni-ventricular reparation.

Primary Outcome Measures

Name	Time	Method
Sex	12 years	Sex of the patient
SpO2	12 years	pre-surgery oxygen saturation
Weight	12 years	Weight of the patient at the time of the intervention
Exact diagnosis	12 years	Exact diagnosis at the time of the intervention
Total number of interventions	12 years	Total number of interventions
Date of death	12 years	If applicable, date of death of the patient
Exact date of intervention	12 years	Exact calender date of intervention
Date of birth	12 years	Date of birth of the patient

Trial Locations

Locations (1)

HUDERF; 🇧🇪 Brussels, Belgium