Clinical trial NCT05089773: Outcomes of Transposition of the Great Arteries After Arterial Switch Operation
Official title: Outcomes of Transposition of the Great Arteries After Arterial Switch Operation: a Dual-center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transposition of Great Vessels
Outcome, Fatal
Keywords: arterial switch operation
late referral
transposition of the great arteries
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Shanghai Children's Medical Center
First posted: 2021-10-22
Enrollment: 1281
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with the great arteries receiving the arterial switch operation in children's hospital of Fudan university and Shanghai children's medical center from January 2000 to March 2020, regardless of the age, sex, and the anatomy.

Brief summary: Transposition of the great arteries (TGA) is a complex cyanotic congenital heart disease and patients suffer from a high mortality rate within one year of age without appropriate management. The therapeutic effect of arterial switch operation (ASO) is satisfactory with low surgery mortality of 2-5%, and thus, has become the treatment of choice for surgical correction of d-TGA. Outcomes of ASO in TGA in china are rare. This is a retrospective study reporting the outcomes of ASO in TGA.

Detailed description: Transposition of the Great Arteries (TGA) is a relatively rare congenital heart disease and surgical treatment in China was developed in recent 20 years. The outcomes of arterial switch operation (ASO) in TGA in China have not been reported before. This study was designed to offer the experience of surgical treatment of TGA in two major pediatric heart centers affiliated in national children's medical center in China. In this retrospective study, a total of 1281 patients diagnosed with TGA received ASO treatment in Fudan Children's Hospital and Shanghai Children's Medical Center were recruited. Medical records and follow-up data of patients were complete. Patient characteristics and clinical data were obtained through review of the medical records, preoperative echocardiography and cardiac catheterization data, operative notes, and follow up reports. Description of the anatomy was confirmed on the preoperative echocardiogram, with clarification from the operative note as needed. Anatomy of the coronary arteries were collected based on the surgical notes. Perioperative data included aorta cross clamping time, cardiopulmonary bypass time and the application of Lecompete maneuver.

Early postoperative complications are defined as delayed sternal closure, active bleeding after surgery, pulmonary artery stenosis, coronary artery re-transplantation, residual ventricular septal defect with significant shunt, atrioventricular block, extracorporeal membrane oxygenation support, cardiac arrest, necrotizing enterocolitis and diaphragmatic eventration. Hospital death was defined as death occurred before discharge.

Follow-up results included echocardiography, cardiac CTA, cardiac catheterization, and angiography. Echocardiographic assessment included color, continuous wave, and pulse wave Doppler date for all valves. Peak pressure gradient of 20mmHg was considered to be stenotic for neoaortic and pulmonary valve. Redo-procedure was defined as any kind of cardiovascular intervention after the ASO procedure including surgery or catheter-based procedure. The indication for reintervention of pulmonary or suprapulmonary stenosis was peak pressure gradient over 40mmHg. Pressure gradient across the LVOT or aortic valve over 50 mmHg was the indication for reintervention. Late death was defined as death occurred during follow up.

Relationships between preoperative and perioperative factors and hospital mortality were evaluated.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with the great arteries receiving the arterial switch operation in children's hospital of Fudan university and Shanghai children's medical center from January 2000 to March 2020.

Exclusion Criteria:

* NA.

Primary outcomes:
measure: hospital mortality
timeFrame: within 1 month after ASO
measure: late death
timeFrame: after 1 month after ASO
measure: redo operation
timeFrame: through study completion, an average of 10 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
city: Shanghai
country: China
facility: Shanghai Children's medical center
Study officials:
affiliation: Children's Hospital of Fudan University
name: Bing Jia, MD, PhD
role: STUDY_CHAIR
References: