Long Term Clinical and Hemodynamic Follow-up of the Sutureless Perceval Bioprothesis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 192
- 主要终点
- survival without Bioprosthetic Valve Failure
研究概览
简要总结
Aortic valve replacement is one of the most commonly performed procedures in adult cardiac surgery in France.
Patients over the age of 65 most often receive a bioprosthetic aortic valve during an isolated aortic valve replacement or in combination with another cardiac surgery, which may extend the operative time.
The Perceval bioprosthesis has the advantage to reduce operative time due to its automatic deployment on a stent, which shortens the suturing time compared to other bioprostheses that require more sutures (sutureless valve).
In this retrospective, single-center, observational descriptive study, the investigators are conducting a follow-up of 193 patients operated on at the Montpellier University Hospital between January 2012 and January 2023, who received a Perceval aortic valve as part of routine annual follow-up, in order to assess the durability of this valve based on clinical and echocardiographic Valve Academic Research Consortium 3 (VARC-3) criteria.
详细描述
Exclusion Criteria :
Perceval bioprosthesis explanted during the same surgical procedure. History of aortic root surgery.
Primary Endpoint :
- Survival free from valve degeneration, according to VARC-3 criteria for structural or non-structural valve dysfunction.
Secondary endpoints :
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with severe or non-severe aortic stenosis, symptomatic or asymptomatic, who received a rapidly deployed Perceval aortic bioprosthesis between January 1, 2012, and January 31, 2023, in the cardiac surgery department at Montpellier University Hospital.
排除标准
- •Perceval bioprosthesis explanted during the same surgical procedure.
- •History of aortic root surgery.
结局指标
主要结局
survival without Bioprosthetic Valve Failure
时间窗: From enrollment to the last news (up to 130 months) or death
次要结局
- Survival without death for cardiac origin(From enrollment to the last news (up to 130 months) or death)
- Survival without reoperation(From enrollment to the last news (up to 130 months) or death)
- survival without pacemaker implantation(From enrollment to the last news (up to 130 months) or death)
- survival without stroke(From enrollment to the last news (up to 130 months) or death)
- Survival without structural valve deterioration(From enrollment to the last news (up to 130 months) or death)
- Survival without rehospitalization for cardiac origin(From enrollment to the last news (up to 130 months) or death)