Congenital Mitral Insufficiency
Conditions
Keywords
congenital heart disease, mitral regurgitation, mitral valve repair
Brief summary
The goal of this observational study is to compare the safety and effectiveness of a 3-steps standardized repair-oriented strategy with annuloplasty only in pediatric patients with mild to moderate mitral valve regurgitation. The main questions it aims to answer are: * Can 3-steps standardized repair-oriented strategy improve both left ventricular and mitral valve function in pediatric patients with mild to moderate mitral valve regurgitation? * Can surgical complications caused by the 3-steps standardized repair-oriented strategy be non-inferior (clinically acceptable) to annuloplasty only? Participants will be assigned to either the Standardized Group (including subvalvular apparatus rehabilitation (leaflet plication if chordae absent on leaflet margin, mal-connected chordae resection if chordae mal-connected to leaflet body, papillary muscle splitting if short chordae or dysplastic or fused papillary muscle etc.), leaflets repair (leaflets plication if functional leaflet prolapse, leaflet cleft closure and patch augmentation for anatomical leaflet defect, etc.) and annuloplasty (posterior annuloplasty for annular dilatation and shallow leaflet coaptation, etc.)) or the Annuloplasty Group (annuloplasty only during mitral repair surgeries. Additionally, echocardiography, electrocardiograms, and measurements of N-terminal pro-brain natriuretic peptide (NT-proBNP) were conducted before the initiation of surgery and at 1 months, 3 months, and 6 months after mitral repair. Researchers will compare the Standardized Group and the Annuloplasty Group to see if the recurrence rate of moderate to severe mitral valve regurgitation, as assessed by echocardiography after 6 months of surgery, is lower in the former than in the latter.
Interventions
PROCEDURE3-steps standardized repair-oriented strategy
3-steps standardized repair-oriented strategy, including subvalvular apparatus rehabilitation (leaflet plication if chordae absent on leaflet margin, mal-connected chordae resection if chordae mal-connected to leaflet body, papillary muscle splitting if short chordae or dysplastic or fused papillary muscle etc.), leaflets repair (leaflets plication if functional leaflet prolapse, leaflet cleft closure and patch augmentation for anatomical leaflet defect, etc.) and annuloplasty (posterior annuloplasty for annular dilatation and shallow leaflet coaptation, etc.)
Sponsors
Shanghai Children's Medical Center
Chinese Academy of Medical Sciences, Fuwai Hospital
Guangzhou Women and Children's Medical Center
Children's Hospital of Chongqing Medical University
China National Center for Cardiovascular Diseases
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 14 Years
Healthy volunteers
No
Inclusion criteria
* \< 14 years old * had not undertake mitral valve surgery before * moderate to severe mitral regurgitation
Exclusion criteria
* moderate to severe mitral regurgitation which concommitant with other cardiac malformation which can not be correct or can only perform palliative surgery * concommitant with mitral stenosis * ischemic mitral regurgitation (for example, concommitant with anomalous origin of coronary artery) * Barlow syndrome * dysplasia of mitral leaflet * complete/Partial endocardial cushion defect * common atrioventricular valve * atrioventricular common channel * cardiomyopathy * other mitral valve surgery contraindications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the recurrence rate of moderate to severe mitral valve regurgitation | after 6 months of surgery | During follow-up visits, echocardiographic examination is conducted to measure the degree of mitral valve regurgitation. If it falls within the moderate to severe range, it is recorded as a recurrence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in symptoms | after 6 months of surgery | Based on patient and caregiver descriptions, if symptoms such as chest discomfort, shortness of breath, and delayed development show improvement following physical activity, it is recorded as an improvement in symptoms. |
| Change in left ventricular function | after 6 months of surgery | Based on the echocardiogram, measurements are taken for left ventricular ejection fraction. |
| NT-proBNP level | after 6 months of surgery | The trend in NT-proBNP levels. |
| Incidence rate of surgical complications | after 6 months of surgery | Incidence rate of surgical complications, including infection, low cardiac output, arrhythmia, cardiac insufficiency, delayed sternal closure, thromboembolism and bleeding events, neurological complications(stroke, seizures and intracerebral hemorrhage). |
Countries
China
Contacts
Primary ContactKai Ma, PhD
Backup ContactZheng Dou, PhD
Outcome results
None listed