Sutureless Closure for Primary Total Anomalous Pulmonary Venous Connection

Study Overview
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Brief Summary
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The purpose of this study is to assess the percentage of pulmonary venous stenosis after TAPVC repair with sutureless closure.

Detailed Description
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Parents of patients with TAPVC after repairing by sutureless technique will be informed about the study. If parents agree to participant in the study and sign the informed consent, the investigators will collect information of patients and echocardiography results at 1 month, 6 month, 12 month and 18 month after the operation.

Official Title
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Short-term and Mid-term Outcome of Sutureless Closure for Primary Total Anomalous Pulmonary Venous Connection

Conditions
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Total Anomalous Pulmonary Venous Connection, Pulmonary Venous Stenosis, Sutureless Closure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with TAPVC operated with sutureless closure and be agreed to join this study by parents from 01/2019 to 06/2024. Exclusion Criteria: TAPVC operated with sutureless closure have single ventricle, isomerism or heterotaxy, congenital pulmonary venous stenosis. TAPVC enrolled to study but cannot the obtain the echocardiography at the time of 1 month, 6 month, 12 month and 18 month.

Ages Eligible for Study
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Maximum Age: 15 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of pulmonary venous stenosis after reparing TAPVC with sutureless technique | The investigators calculate pulmonary venous score (PVS) based on the mean gradient through each pulmonary vein. Then we sum all the score of each pulmonary vein, range from 0 to 12, and classify to 4 levels. Score 0 if the mean gradient is less than 2mmHg, 1 if it is from 2 to 6,9mmHg, 2 if it is from 7 mmHg and above, and 3 if the vein is occluded. The degree of obstruction is classified as follow: none (0 to 1), mild (2 to 3), moderate (4 to 7), and severe (from 8 and above). | The investigators assess the PVS at the time of 12 month after the operation. | 
| Early mortality (<30 days) | Early mortality is defined when patients die within 30 days since the operation | 30 days | 
| The percentage of pulmonary venous stenosis after reparing TAPVC with sutureless technique | The investigator calculate pulmonary venous score (PVS) based on the mean gradient through each pulmonary vein. Then we sum all the score of each pulmonary vein, range from 0 to 12, and classify to 4 levels. Score 0 if the mean gradient is less than 2mmHg, 1 if it is from 2 to 6,9mmHg, 2 if it is from 7 mmHg and above, and 3 if the vein is occluded. The degree of obstruction is classified as follow: none (0 to 1), mild (2 to 3), moderate (4 to 7), and severe (from 8 and above). | The investigators assess the PVS at the time of 18 month after the operation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late mortality (> 30 days) | Late mortality is defined when patients die beyond 30 day since the operation | The investigators assess mortality at the time of 18 month after the operation | 
| The percentage of pulmonary venous stenosis after reparing TAPVC with sutureless technique | The investigator calculate pulmonary venous score (PVS) based on the mean gradient through each pulmonary vein. Then we sum all the score of each pulmonary vein, range from 0 to 12, and classify to 4 levels. Score 0 if the mean gradient is less than 2mmHg, 1 if it is from 2 to 6,9mmHg, 2 if it is from 7 mmHg and above, and 3 if the vein is occluded. The degree of obstruction is classified as follow: none (0 to 1), mild (2 to 3), moderate (4 to 7), and severe (from 8 and above). | The investigators assess the PVS at the time of 6 month after the operation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAPVC, Sutureless, Pulmonary venous stenosis