Myocardial Biopsy in Congenital Cardiac Surgery

Study Overview
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Brief Summary
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Despite major advances in the technical aspects of surgical repair of congenital heart diseases, perioperative myocardial damage with low cardiac output remains the most common cause of morbidity and death after repair of congenital heart lesions.

Detailed Description
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Myocardial sample was obtained from the endocardial surface of the right ventricle and placed in formalin until examination under light microscopy for detection of myocyte cellular edema as a marker of ischemic changes.

Official Title
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Does Intraoperative Myocardial Biopsy Have Any Prognostic Value in Predicting Myocardial Protection After Congenital Cardiac Surgery

Conditions
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Myocardial Protection

Intervention / Treatment
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* Procedure: myocardial biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled cardiac surgery requiring cardioplegic arrest with expected cross clamp time>45 minutes. Hemodynamic stability. Exclusion Criteria: Previous cardiac surgery. Urgent or emergent cases. Any known allergies to components of either cardioplegia solutions.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 6 Years

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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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional Model Description: Myocardial cell edema either focal or diffuse was detected in histopathological examination in pediatric patients undergoing total repair of Tetrology of Fallout
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Myocardial biopsy<br>The specimens were classified into three categories: normal, focal hydropic change and diffuse hydropic change. | Procedure: myocardial biopsy<br>* Myocardial cell edema either focal or diffuse was detected in histopathological examination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial biopsy | Myocardial cell edema either focal or diffuse was detected in histopathological examination | within 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The inotropic score | 1 point is assigned for each mcg/kg/min of dopamine and dobutamine, and 10 points is assigned for each 0.1 mcg/kg/min of epinephrine, norepinephrine, and phenylephrine. (i.e. 1 point is assigned for each 10 ng/kg/min of epinephrine, norepinephrine, and phenylephrine. | within one month | 
| Serum cardiac troponin level | Samples for troponin I levels at baseline, 6, 12 and 24 hours after aortic cross-clamping. | first 24 hours | 
| 30-day mortality | number of patients died | 30 days | 
| Type of cardiac rhythm on return | Type of cardiac rhythm on return | within 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Protection, Pediatric, Myocardial biopsy, Cardiopulmonary Bypass