Sutureless Technique and Conventional Repairs for Total Anomalous Pulmonary Venous Connection

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of conventional repair and sutureless surgical repair of total anomalous pulmonary venous connection.

Detailed Description
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An observational, non-randomized multi-center study is proposed to compare the efficacy between conventional repair and sutureless technique for total anomalous pulmonary venous connection. Subjects will be enrolled at Guangdong Provincial People's Hospital (GPPH) and three to five participating hospitals. All clinical interventions will follow the participating hospital's standard of care. Informed consent will be obtained from all study participants before study enrollment. After undergoing their surgical repairs, study participants will be followed up at 1, 3, 6 and 12 months after initial surgery and annually thereafter. All preoperative and postoperative medical records data will be submitted to a centralized database at GPPH through a secure online research platform. Baseline and post-operative (6 months) assessments will include a history and physical examination, a quality of life survey, physical examinations, liver and kidney function assessments, serum brain natriuretic peptide (BNP), echocardiography and electrocardiography. Besides, a small amount of common pulmonary vein tissue may be required for hematein and eosin staining.

Official Title
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Sutureless Technique and Conventional Repairs for Total Anomalous Pulmonary Venous Connection: an Observational Study by Chinese Heart Centers

Conditions
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Total Anomalous Pulmonary Venous Connection

Intervention / Treatment
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* Procedure: Surgical strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants and neonates who are diagnosed with TAPVC Infants and neonates who undergo initial surgical repair for TAPVC. Exclusion Criteria: Concommitant diagnoses including functional single ventricular, double outlet right ventricle, tricuspid atresia, pulmonary atresia, or transposition of the great arteries. Older than 1-year-old.

Ages Eligible for Study
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Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Conventional surgical group<br>Patients with total pulmonary venous connection undergo conventional surgical repair | Procedure: Surgical strategy<br>* To compare the efficacy between conventional repair and sutureless technique for total anomalous pulmonary venous connection<br>|
| Sutureless surgical group<br>Patients with total pulmonary venous connection undergo sutureless surgical repair | Procedure: Surgical strategy<br>* To compare the efficacy between conventional repair and sutureless technique for total anomalous pulmonary venous connection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of postoperative pulmonary venous obstruction (PVO) | in anastomosis or arborizations of pulmonary veins | 2 years | 
| Mortality rate | all causes and surgical repair related | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The scores of postoperative quality of life: rating scale | Fill the rating scale through telephone or other communication | 2 years | 
| Change in resting oxygen saturation | Answer question through telephone or other communication | 2 years | 
| Value of tricuspid annular plane systolic excursion | Measured by echocardiology from follow-up | 2 years | 
| Development of all kinds of arrhythmia | Measured by electrocardiography | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAPVC, Surgical strategy, PVO, outcomes