Clinical trial NCT03047343: Evolution of Two Cohorts of Children (Univentricular and Bi-ventricular Heart) After Strapping of the Pulmonary Artery
Official title: Evolution of Two Cohorts of Children (Univentricular and Bi-ventricular Heart) After Strapping of the Pulmonary Artery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Malformations
Keywords: pulmonary artery strapping
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 79
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients treated with pulmonary artery strapping between 2005 and 2016 at the Queen Fabiola Children Hospital.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Outdated indications

Primary outcomes:
measure: Date of birth
timeFrame: 12 years
measure: Sex
timeFrame: 12 years
measure: Weight
timeFrame: 12 years
measure: Exact diagnosis
timeFrame: 12 years
measure: Exact date of intervention
timeFrame: 12 years
measure: Total number of interventions
timeFrame: 12 years
measure: SpO2
timeFrame: 12 years
measure: Date of death
timeFrame: 12 years
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: HUDERF
Study officials:
affiliation: HUDERF
name: Nicolas Bellofatto Piazza
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Brugmann
name: Pierre Wauthy, MD
role: STUDY_DIRECTOR
References:
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. doi: 10.1016/s0003-4975(10)62881-0.
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. doi: 10.1016/s1010-7940(96)01049-4.
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. doi: 10.1590/s0102-76382009000400011. English, Portuguese.
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. doi: 10.1016/s0003-4975(02)03900-0.
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. doi: 10.1016/j.athoracsur.2003.12.113. No abstract available.
citation: 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.