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

NCT03047343 | Completed

• 1 other identifier: CHUB-strapping
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Malformations

Keywords

pulmonary artery strapping

Outcome Measures

Primary Outcomes (8)

• 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

• SpO2

  pre-surgery oxygen saturation

  12 years

• Date of death

  If applicable, date of death of the patient

  12 years

Study Arms (2)

Uni-ventricular reparation

All patients treated with pulmonary artery strapping between 2005 and 2016 at the Queen Fabiola Children Hospital. Patients benefiting from an uni-ventricular reparation.

Other: Retrospective data extraction in medical files

Bi-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.

Other: Retrospective data extraction in medical files

Interventions

Retrospective data extraction in medical files OTHER

Retrospective data extraction in medical files

Bi-ventricular reparation; Uni-ventricular reparation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Outdated indications

Sponsors & Collaborators

• Pierre Wauthy: lead

Study Sites (1)

HUDERF

Brussels, 1020, Belgium

Location

Related Publications (6)

• 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.

  PMID: 2476086 BACKGROUND

• 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.

  PMID: 9030797 BACKGROUND

• 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.

  PMID: 20011878 BACKGROUND

• 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.

  PMID: 12400772 BACKGROUND

• 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.

  PMID: 15797113 BACKGROUND

• 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.

  PMID: 21733709 BACKGROUND

Study Officials

• Nicolas Bellofatto Piazza

  HUDERF

  PRINCIPAL INVESTIGATOR

• Pierre Wauthy, MD

  CHU Brugmann

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of clinic

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 8, 2017
• Study Start: March 1, 2017
• Primary Completion: May 29, 2018
• Study Completion: May 29, 2018
• Last Updated: May 31, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)