Evolution of Two Cohorts of Children (Univentricular and Bi-ventricular Heart) After Strapping of the Pulmonary Artery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Sex
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients treated with pulmonary artery strapping between 2005 and 2016 at the Queen Fabiola Children Hospital
排除标准
- •Outdated indications
结局指标
主要结局
Sex
时间窗: 12 years
Sex of the patient
SpO2
时间窗: 12 years
pre-surgery oxygen saturation
Weight
时间窗: 12 years
Weight of the patient at the time of the intervention
Exact diagnosis
时间窗: 12 years
Exact diagnosis at the time of the intervention
Total number of interventions
时间窗: 12 years
Total number of interventions
Date of death
时间窗: 12 years
If applicable, date of death of the patient
Exact date of intervention
时间窗: 12 years
Exact calender date of intervention
Date of birth
时间窗: 12 years
Date of birth of the patient
次要结局
未报告次要终点
研究者
Pierre Wauthy
Head of clinic
Brugmann University Hospital
