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

Congenital Heart Malformations Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03047343
• Other study ID #: CHUB-strapping
• Status: Completed
• Start date: March 1, 2017
• Est. completion date: May 29, 2018

Study information

• Verified date: May 2018
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: May 29, 2018
• Est. primary completion date: May 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Outdated indications

Related Conditions & MeSH terms

• Congenital Abnormalities
• Congenital Heart Malformations
• Heart Defects, Congenital

Intervention

Other:
• Retrospective data extraction in medical files
Retrospective data extraction in medical files

Locations

Country	Name	City	State
Belgium	HUDERF	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Wauthy

Country where clinical trial is conducted

Belgium, 

References & Publications (6)

Brooks A, Geldenhuys A, Zuhlke L, Human P, Zilla P. Pulmonary artery banding: still a valuable option in developing countries? Eur J Cardiothorac Surg. 2012 Feb;41(2):272-6. doi: 10.1016/j.ejcts.2011.05.053. Epub 2011 Dec 12. — View Citation

Horowitz MD, Culpepper WS 3rd, Williams LC 3rd, Sundgaard-Riise K, Ochsner JL. Pulmonary artery banding: analysis of a 25-year experience. Ann Thorac Surg. 1989 Sep;48(3):444-50. — View Citation

Pinho P, Von Oppell UO, Brink J, Hewitson J. Pulmonary artery banding: adequacy and long-term outcome. Eur J Cardiothorac Surg. 1997 Jan;11(1):105-11. — View Citation

Takayama H, Sekiguchi A, Chikada M, Noma M, Ishizawa A, Takamoto S. Mortality of pulmonary artery banding in the current era: recent mortality of PA banding. Ann Thorac Surg. 2002 Oct;74(4):1219-23; discussion 1223-4. — View Citation

Valente AS, Mesquita F, Mejia JA, Maia IC, Maior MS, Branco KC, Pinto VC Jr, Carvalho W Jr. Pulmonary artery banding: a simple procedure? A critical analysis at a tertiary center. Rev Bras Cir Cardiovasc. 2009 Jul-Sep;24(3):327-33. English, Portuguese. — View Citation

Yoshimura N, Yamaguchi M, Oka S, Yoshida M, Murakami H. Pulmonary artery banding still has an important role in the treatment of congenital heart disease. Ann Thorac Surg. 2005 Apr;79(4):1463; author reply 1463-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Date of birth	Date of birth of the patient	12 years
Primary	Sex	Sex of the patient	12 years
Primary	Weight	Weight of the patient at the time of the intervention	12 years
Primary	Exact diagnosis	Exact diagnosis at the time of the intervention	12 years
Primary	Exact date of intervention	Exact calender date of intervention	12 years
Primary	Total number of interventions	Total number of interventions	12 years
Primary	SpO2	pre-surgery oxygen saturation	12 years
Primary	Date of death	If applicable, date of death of the patient	12 years