Small Aortic Annulus - a New Solution to the Old Problem
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Indexed effective orifice area, cm²/m²
研究概览
简要总结
In this prospective single-center study included 60 patients with a severe degenerative aortic stenosis and small aortic annulus (<21 mm) who underwent standard AVR with stented bioprosthesis (group 1, n=30) and aortic valve reconstruction using autologus pericardium (Ozaki procedure) (group 2, n=30)
详细描述
Aortic valve replacement (AVR) in patients with a small aortic annulus is a challenging problem. Implantation of a small aortic valve sometimes leads to high residual gradients, despite a normally functioning prosthesis. Patients with a small aortic annulus, especially those with a large body surface area, are at higher risk of prosthesis-patient mismatch, which is associated with worse clinical outcomes and decreased survival. The purpose of this study was to compare the hemodynamic performance among the 2 management strategies (standard AVR with stented bioprosthesis and Ozaki procedure) in the context of a small aortic annulus (<21 mm)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •severe degenerative aortic valve stenosis
排除标准
- •redo operation, infective endocarditis
结局指标
主要结局
Indexed effective orifice area, cm²/m²
时间窗: 12 months after surgery
Assessment of aortic valve dimension
次要结局
- prosthesis-patient mismatch (PPM)(12 months after surgery)
- Peak pressure gradient, mm.Hg(12 months after surgery)
- Mean pressure gradient, mm.Hg(12 months after surgery)
- Effective orifice area, EOA, cm²(12 months after surgery)
研究者
Mikulyak Artur
Principal Investigator, Cardiovascular surgeon
The Federal Centre of Cardiovascular Surgery, Russia