Influence of Timing of Switch Operation in Transposition of Great Arteries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
Transposition of great vessels are usually corrected by an arterial switch operation. This operation is often done during the first week of life as surgical delays lead to deconditioned left ventricle. On the other hand early surgery carries also risks as neonatal physiology may have problems adapting to an intervention under cardiopulmonary bypass, possible pulmonary hypertension. Arterial switch operation between 2008 and 2020 done at our center will be reviewed. Primary outcome will be mortality or severe postoperative morbidity. Patients will be divided in 2 groups according to the presence or absence of the primary outcome. After propensity score matching, they will be analysed according to the timing of operation.
详细描述
Scientific background and motivation
The transposition of great vessels (TGV) is a congenital heart defect in which the aorta follows the right ventricle and the pulmonary artery follows the left ventricle. At birth, the pulmonary and systemic circulations work in parallel and the communication between them depends on shunts in the cardiac stage (permeability of the Botal hole) or in the supra-cardiac (ducis arteriosus).
It's the most common congenital heart disease and his incidence is estimated between 0.7 and 0.8 per 1000 births. It's a pathology that may be associated with other heart defects, such as interventricular communication (IVC) or pulmonary stenosis, but rarely with a chromosomal abnormality or malformative syndrome.
TGV's manifestation is an isolated cyanosis, refractory to oxygen. And mortality reaches 90% in the first year of life in absence of treatment.
TGV's management has evolved over the last 50 years. First, thanks to the antenatal ultrasound diagnosis, allowing early strategies in postnatal to maintain a shunt between the two circulations (Prostaglandin and Balloon atrial septostomy). Then, by the evolution of corrective surgeries; indeed atrial repair techniques (Senning and Mustard) have given way to the arterial Switch with coronary reimplantation by microsurgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborns with TGV and
- •operated at HUDERF between 2008 and 2020 and
- •arterial switch operation
排除标准
- •Any surgical technique other than the switch operation for TGV
- •patients operated before 2008
结局指标
主要结局
Mortality
时间窗: From operation until 28 days postoperatively
death (percent) during hospitalization
Incidence (percent) of severe postoperative morbidity
时间窗: From operation until 28 days postoperatively
Severe postoperatively morbidity is defined as patients meeting at least 2 of the following events: * respiratory failure defined as duration of mechanical ventilation \> 75th percentile of our cohort * prolonged inotropic support defined as duration of inotropic support \> 48 hours * renal failure defined as glomerular filtration rate (GFR) decreased more than 75% compared to preoperative GFR Every patient meeting at least 2 of these 3 events will be counted as having severe postoperative morbidity. Total incidence (expressed as percent of total population) of severe postoperative morbidity will be recorded.
次要结局
未报告次要终点
研究者
Denis SCHMARTZ
Head, Department of Anesthesiology
Brugmann University Hospital