Role of Preoperative Angiographic Collateral Embolization in Patients Undergoing Repair of Tetralogy of Fallot Tetralogy of Fallot, major aortopulmonary collateral arteries (MAPCAs), angiography, embolization, pulmonary hemorrhage, randomized controlled trial, congenital heart surgery
Conditions
Interventions
Preoperative angiography with embolization of significant MAPCAs if identified, followed by corrective surgery.,Direct corrective surgery with only transthoracic echocardiographic imaging and no angio
Active Comparator Procedure/Surgery,Active Comparator Procedure/Surgery
Group 1 (Angio arm),Group 2 (Surgical arm)
Sponsors
UNIVERSITY OF CHILD HEALTH SCIENCES
Eligibility
Sex/Gender
All
Age
1 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1- Children greater than one year and up to 12 years of age with a diagnosis of TOF were eligible if transthoracic echocardiography confirmed anatomy suitable for complete repair.
Exclusion criteria
Exclusion criteria: 1- Patients who had previously undergone cross-sectional imaging (CT angiography or cardiac catheterization) 2-Prior palliative shunt procedures 3- Those deemed unsuitable for complete repair on echocardiography were excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative pulmonary hemorrhage During index hospitalization following surgical repair Binary clinical event based on postoperative assessment,Pulmonary edema During index hospitalization following surgical repair Binary clinical event based on postoperative assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| Mortality During index hospitalization Binary,Vasoactive Inotropic Score (VIS) at 24 hours & peak VIS First 24 hours + peak during ICU stay Continuous,ICU length of stay Entire ICU stay Continuous (days),Ventilation Outcomes (Duration of mechanical ventilation, Early extubation (less than 24 hours), Prolonged ventilation (more than 48 hours), Reintubation Postoperative ICU course Mixed (continuous + categorical),Cardiac Arrhythmias (including JET) Low Cardiac Output Syndrome (LCOS) During hospitalization Binary,Infectious (Sepsis, Pneumonia, Wound infection) During hospitalization Binary,Neurologic events During hospitalization Binary,Transfusion Requirement Perioperative period Continuous / categorical,Angiography-Specific Outcomes (MAPCA detection rate MAPCA embolization success rate Angiography-related complications: Hypercyanotic spells, Seizures, Unplanned ICU admission, Prolonged hospital stay) Preoperative (angiography phase) Mixed,Intraoperative Variables, Cardiopulmonary bypass time, Cross-clamp time, Type of repair: Pulmonary valve preservation, Transannular patch) Postoperative Continuous / categorical | — |
Countries
Pakistan
Contacts
Public ContactSyed Salman Shah
THE CHILDREN HOSPITAL & UNIVERSITY OF CHILD HEALTH SCIENCES, LAHORE, PAKISTAN
Outcome results
None listed