The goal of this observational study is to learn about recovery after heart surgery for people with Complex Congenital Heart Disease (CCHD), build a comprehensive data platform for CCHD care across a person's whole life, and create a China-specific quality control system to improve CCHD surgical care.
The main questions it aims to answer are:
What are the main risk factors that affect how well people with CCHD recover after heart surgery? Can a whole life course, multi-dimensional data platform for CCHD care be built to support better clinical quality control? Can a China-specific system to evaluate and control the quality of CCHD heart surgery be developed to guide national health policies and improve patient outcomes?
Participants in this study are people with CCHD who have had or will have heart surgery at participating medical centers. This includes two groups:
A retrospective group: People who already had CCHD heart surgery and were included in the existing National Congenital Heart Disease Surgery Database.
A prospective group: People who are scheduled to have CCHD heart surgery as part of related sub-studies of this project.
People who are lost to follow-up or have more than 30% missing data will not be included.
Participants will:
For the retrospective group: Have their past medical records (from surgery and follow-up) analyzed by researchers to find risk factors linked to recovery after CCHD heart surgery.
For the prospective group: Have their pre-surgery tests, surgery details, care during and after surgery, and follow-up data (including up to 1 year after surgery) collected as part of their regular medical care.
Researchers will combine data from both groups into a new registry, work with a third-party committee to check data quality, and use this combined data to build a quality control and evaluation system for CCHD heart surgery. This system will help show the current state of CCHD care in China and guide national health decisions.
Clinical diagnosis of Complex Congenital Heart Disease (CCHD) who underwent surgical intervention and were enrolled in the 13th Five-Year Plan National Congenital Heart Disease Surgery Database
Clinical diagnosis of CCHD requiring surgical/intrauterine intervention or cardiac rehabilitation
Willing to sign informed consent and complete follow-up
Lost to follow-up
>30% missing core clinical data
Severe extracardiac malformations, systemic dysfunction, or other conditions precluding study participation, per sub-study specific exclusion criteria
This study population includes two cohorts of patients with Complex Congenital Heart Disease (CCHD) undergoing surgical intervention: 1. Retrospective cohort: Patients with CCHD who were enrolled in National Congenital Heart Disease Surgery Database and had received cardiac surgery. 2. Prospective cohort: Consecutive patients with CCHD scheduled for surgical intervention as part of related sub-studies of this project, recruited from participating medical centers across China.
Cohort
Other
Not listed
Identification of key risk factors for CCHD post-surgical recovery
To identify and validate 5 key risk factors linked to perioperative adverse events and post-surgical recovery in patients with Complex Congenital Heart Disease (CCHD) using retrospective cohort data.
Development of a China-specific CCHD surgical quality control system
To establish a China-specific quality control and evaluation system for CCHD surgical care, which will reflect variations in CCHD care across disease subtypes, age groups, and regions, and guide improvements in clinical outcomes, medical resource use, and patient quality of life.
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