Surgical Valvuloplasty for Congenital Mitral Insufficiency

Study Overview
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Brief Summary
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Congenital mitral insufficiency is one of the most common valvular diseases in the pediatric population worldwide, carrying a high morbidity and mortality risk if not treated immediately and properly. Given that mitral replacement likely increased risk of cardiac dysfunction and mitral reoperation, mitral repair is the currently preferred surgical strategy in the majority of pediatric patients with mitral insufficiency. Unfortunately, previous evidences demonstrated the long-term hemodynamic alteration in response to significant mitral regurgitant might lead to a reversible or irreversible pulmonary vascular remodeling regardless of concomitant other cardiac malformations, which is associated with increased risk of morbidity and mortality following the surgery. Currently available researches mainly focused the association of pulmonary vascular pressures with risk of mortality and morbidity on adult rheumatic or degenerative mitral insufficiency; however, knowledge is still lacking regarding pediatric population with congenital mitral insufficiency. The investigator wil assess the relationship between baseline sPAP and risk of operative morbidity and mortality.

Official Title
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Individualized Surgical Repair for Congenital Mitral Insufficiency in Infants and Children

Conditions
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Mitral Insufficiency, Pulmonary Arterial Hypertension

Intervention / Treatment
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* Procedure: mitral valvuloplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: evidence of normal or preserved left ventricular systolic function (defined as left ventricular ejection fraction [LVEF] >50%); native mitral regurgitation of grade moderate or greater; with or without systemic-to-pulmonary shunting necessitating concomitant surgical repairs, regardless of pulmonary arterial pressure or pulmonary artery wedge pressure. Exclusion Criteria: functional single ventricle; rheumatic mitral diseases; Eisenmenger syndrome; aortopathy, transposition of the great arteries, obstructions of ventricular outflow tract, malignant arrhythmias, cardiomyopathy, microbiological identification of infective endocarditis; a history of pericardiotomy or intervention therapy.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 18 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: mitral valvuloplasty|Commissural plication was the most commonly used technique to repair mitral insufficiency, which was selectively supplemented by a specific combination of one or more of the following procedures: cleft closure, chordal shortening, transposition or replacement, edge-to-edge repair, leaflet augmentation, or division of papillary muscles, depending on the individual etiology and anatomy.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence-free survival | recurrence-free survival is defined as free of more than moderate mitral valve regurgitation | Postoperatively; until five years after initial operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | All postoperative complications and their treatment will be registered. | Postoperatively, until one month after initial operation |