The Choice of Mitral Valve Surgery Type and Mid-term Outcomes in Patients up to 70-years: Results of the AUTHEARTVISIT Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,520
- 主要终点
- all-cause death
研究概览
简要总结
The goal of this observational study is to learn about the long-term effects of mechanical versus biological mitral valve replacement in patients aged 70 years or younger. The main question it aims to answer is:
Do patients who receive a mechanical mitral valve live longer and need fewer repeat operations compared with those who receive a biological valve? Participants are patients in Austria who already had mitral valve surgery between 2010 and 2020 as part of their regular medical care. Information about their surgeries, health conditions, and outcomes was collected from national health insurance records. Researchers will follow these patients for up to 10 years to compare survival, reoperation rates, and other heart-related events between mechanical and biological valve recipients.
详细描述
This nationwide, registry-based, retrospective cohort study is part of the AUTHEART VISIT project, which investigates long-term outcomes of cardiac surgery in Austria. The present analysis focuses on patients aged 70 years or younger undergoing surgical mitral valve replacement (MVR) between January 1, 2010 and December 31, 2020. The aim is to evaluate differences in survival, reoperation rates, and cardiovascular outcomes between patients receiving mechanical mitral valve replacement (SMMVR) and those receiving biological mitral valve replacement (SBMVR).
Data source and registry procedures:
Data were obtained from the Austrian Health Insurance Funds, which cover approximately 98% of the Austrian population. The registry includes detailed patient-level information on diagnoses, procedures, and outcomes based on mandatory coding for reimbursement (ICD-10 for diagnoses and MEL codes for surgical procedures). The data are anonymized prior to analysis.
Quality assurance:
Data integrity is ensured by several mechanisms:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mitral valve surgery between 01.01.2010 and 31.12.2020
排除标准
- •concomitant procedures on other valves
结局指标
主要结局
all-cause death
时间窗: 10 years
rate of all-cause death
次要结局
- reoperation-free survival(10 years)
- major adverse cardiac events(10 years)
- reoperation(10 years)
- heart failure(10 years)
- myocardial infarction(10 years)
- stroke(10 years)
- intracerebral hemorrhage(10 years)
- bleeding other than ICH(10 years)
研究者
Alissa Florian
Dr.
Medical University of Vienna