Comparison of Automated Fastener Device Versus Manually Tied Knot in Minimally-invasive Isolated Aortic Valve Replacement Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 221
- 主要终点
- Cardiac surgery times
研究概览
简要总结
The aim of the investigator's study was to evaluate the efficacy and the safety of the Cor-Knot device in isolated aortic valve replacement (AVR) by right anterior minithoracotomy (RAMT).
Four hundred and forty patients were operated for AVR by RAMT. Of these patients, 221 underwent isolated AVR surgery with stented prosthesis. Sutures were secured using the Cor-Knot titanium fastener in 63 patients and knots were hand-tied in 158.
The aortic cross-clamping and cardiopulmonary bypass times were significantly decreased in the AT group compared with the MT group. Clinical outcomes were similar in the two groups, whether in the analysis of non-matched or matched groups. There was no difference in 30 day-mortality and the stroke and TIA rates were comparable The automated Cor-Knot fastener is an easy-to-use, time-saving device which does not increase perioperative morbi-mortality in patients undergoing AVR by right anterior minithoracotomy.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 years
- •Elective patient
- •Isolated aortic valve replacement with stented prosthesis
- •Minimally-invasive approach (right anterior minithoracotomy)
排除标准
- •Associated procedure
- •Aortic valve replacement with sutureless or rapid valve deployment prosthesis
- •Active endocarditis
- •Prior cardiac surgery
结局指标
主要结局
Cardiac surgery times
时间窗: peroperative data
Aortic cross-clamping and cardiopulmonary bypass times
次要结局
- Morbimortality(Perioperative (30 days) and 24 months follow up)
研究者
MORGANT Marie-Catherine
Principal investigator
Centre Hospitalier La Chartreuse