Outcomes of Transposition of the Great Arteries After Arterial Switch Operation

Outcomes of Transposition of the Great Arteries After Arterial Switch Operation: a Dual-center Study

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.

Study Overview

• Status: Completed
• Conditions: Transposition of Great Vessels; Outcome, Fatal
• Intervention / Treatment: Procedure: The arterial switch operation

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.

• Study Type: Observational
• Enrollment (Actual): 1281

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai Children's Medical Center
  • Shanghai, China, 200000
    • Children's Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

group 1; The only group in this retrospective study includes patients diagnosed with transposition of the great arteries receiving arterial switch operation in children's hospital of fudan university and shanghai children's medical center.

Procedure: The arterial switch operation; The ASO is a procedure that emerged as an anatomically as well as physiologically appropriate solution to the transposition of the great arteries. The aorta and pulmonary artery are detached from their native roots and reattached to the opposite root; thus, the pulmonary root becomes the neo-aorta, and the aortic root becomes the neo-pulmonary artery. The coronary arteries are transplanted from the aorta/neo-pulmonary artery to the pulmonary artery/neo-aorta.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hospital mortality	death occurred within the hospital	within 1 month after ASO
late death	death occurred after discharge	after 1 month after ASO
redo operation	reintervention after the ASO procedure	through study completion, an average of 10 year

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Collaborators: Shanghai Children's Medical Center
• Investigators: Study Chair: Bing Jia, MD, PhD, Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): March 30, 2020
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: March 10, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Actual): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 20, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: transposition of the great arteries; arterial switch operation; late referral
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Transposition of Great Vessels; Situs Inversus
• Other Study ID Numbers: TGA-CTS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No