Cardiac Catheterization, Congenital Heart Disease (CHD), Postoperative Complications, Ventricular Septal Defects (VSD)
Conditions
Brief summary
The goal of this observational study is to develop and validate a multimodal artificial intelligence prediction model for treatment-related complications in children with perimembranous ventricular septal defect (pmVSD) undergoing transcatheter device closure. The main question it aims to answer is: Can an AI model that integrates demographics, laboratory results, electronic health record text, echocardiography reports, chest radiographs, and electrocardiogram accurately predict the risk of complications at the individual patient level? Data will be retrospectively collected from routine clinical care records of pediatric patients who underwent transcatheter closure for pmVSD. Deep learning methods will be used to extract features from text and images to train and validate the prediction model.
Interventions
None listed
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Age ≤ 18 years at the time of transcatheter procedure. * Diagnosis of perimembranous ventricular septal defect confirmed by echocardiography, and underwent transcatheter device closure at the study center. * Medical records sufficient to ascertain the primary outcome within the pre-specified follow-up window, and availability of minimum baseline clinical information required for model development/validation.
Exclusion criteria
* Ventricular septal defects not classified as perimembranous on echocardiography, including muscular, outlet, or inlet VSDs, as well as multiple or complex VSDs involving more than one septal region. * Presence of complex congenital heart disease or associated structural abnormalities requiring concomitant surgical repair (e.g., tetralogy of Fallot). * Prior surgical VSD repair or prior transcatheter VSD closure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Procedure-Related Complications After Transcatheter Closure of Perimembranous VSD | Up to 30 Days After Transcatheter Closure | Occurrence of a composite endpoint of procedure-related complications, including arrhythmia requiring treatment, new-onset or worsened valvular regurgitation, residual shunt requiring reintervention, and device embolization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Precision-Recall Curve (AUCPR) for Complication Prediction | Up to 30 Days After Transcatheter Closure | The area under the precision-recall curve (AUCPR) of the model for predicting the primary composite procedure-related complication endpoint. |
| Sensitivity of the Model at a Pre-Specified Risk Threshold | Up to 30 Days After Transcatheter Closure | Sensitivity for predicting the primary composite procedure-related complication endpoint at a pre-specified probability (risk) threshold. |
| Positive Predictive Value (PPV) of the Model at a Pre-Specified Risk Threshold | Up to 30 Days After Transcatheter Closure | Positive predictive value (PPV) for predicting the primary composite procedure-related complication endpoint at the same pre-specified probability (risk) threshold. |
| Negative Predictive Value (NPV) of the Model at a Pre-Specified Risk Threshold | Up to 30 Days After Transcatheter Closure | Negative predictive value (NPV) for predicting the primary composite procedure-related complication endpoint at the same pre-specified probability (risk) threshold. |
Countries
China
Contacts
CONTACTKun Sun
Outcome results
None listed