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Sponsor study identifier
observational
79
1 country
1
Study Start
March 1, 2017
Actual (reported)Primary Completion
May 29, 2018
Actual (reported)Study Completion
May 29, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 29, 2018
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 7, 2017
Actual (reported)February 8, 2017
Actual (reported)March 1, 2017
Actual (reported)May 29, 2018
Actual (reported)May 29, 2018
Actual (reported)Date of birth
Date of birth of the patient
12 years
Sex
Sex of the patient
12 years
Weight
Weight of the patient at the time of the intervention
12 years
Exact diagnosis
Exact diagnosis at the time of the intervention
12 years
Exact date of intervention
Exact calender date of intervention
12 years
Total number of interventions
Total number of interventions
12 years
All patients treated with pulmonary artery strapping between 2005 and 2016 at the Queen Fabiola Children Hospital. Patients benefiting from an uni-ventricular reparation.
All patients treated with pulmonary artery strapping between 2005 and 2016 at the Queen Fabiola Children Hospital. Patients benefiting from an bi-ventricular reparation.
Retrospective data extraction in medical files
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
All patients treated with pulmonary artery strapping between 2005 and 2016 at the Queen Fabiola Children Hospital.
HUDERF
Brussels, 1020, Belgium
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.
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.
Nicolas Bellofatto Piazza
HUDERF
Pierre Wauthy, MD
CHU Brugmann
79 participants (actual enrollment reported by the registry).
First Submitted
February 7, 2017
First Posted
February 8, 2017
Study Start
March 1, 2017
Actual (reported)SpO2
pre-surgery oxygen saturation
12 years
Date of death
If applicable, date of death of the patient
12 years
Contact the study team to confirm eligibility.
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.
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.
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.
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.
Primary Completion
May 29, 2018
Actual (reported)Study Completion
May 29, 2018
Actual (reported)Last Updated
May 31, 2018
Record last verified: 2018-05
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Source: ClinicalTrials.gov.
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