Surgical and Transcatheter Aortic Valve Replacement for Aortic Stenosis in Low-risk Elective Patients. Data From Multicenter Registry.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,393
- 主要终点
- all-cause death
研究概览
简要总结
Multicenter registry data analysis of aortic valve stenosis patients that underwent elective, isolated transcutaneous aortic valve implantation (TAVI) or surgical aortic valve replacement between 2015 and 2019. In TAVI group only transfemoral access was considered.
详细描述
A retrospective analysis of the Multicenter Aortic Valve Registry patients operated between 2015 and 2019 in the three departments of cardiac surgery in Poland: the Medical University of Silesia in Katowice, Medical University in Gdańsk, and Poznań, University of Medical Science. Baseline clinical, procedural, and outcome data at follow-up were entered into prespecified electronic case report forms. Follow-up status was validated by personal contact or access to Polish National Health Fund. Patients with planned concomitant intervention on coronary arteries (by bypass grafting or percutaneous intervention), other valvular interventions, arrhythmia ablation, or left atrial appendage occlusion were excluded too. In TAVI group only femoral access was considered. For SAVR any tissue or mechanical valve implantation in an aortic position with sternotomy or minimal access was included.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Elective procedure
- •Aortic valve replacement with means of TAVI or SAVR
排除标准
- •Concomitant procedures
结局指标
主要结局
all-cause death
时间窗: up to 6 years
death resulting from cardiovascular and non-cardiovascular causes
次要结局
未报告次要终点
研究者
Mariusz Kowalewski
PhD, M.D.
Nicolaus Copernicus University
