Endo-aortic Versus Trans-thoracic Clamping in Right Mini-thoracotomy Mitral Valve Repair: Outcome on Myocardial Pro-tection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 主要终点
- CK-MB levels immediately after surgery
研究概览
简要总结
Perfusion strategies and aortic clamping techniques for right mini-thoracotomy mitral valve (MV) surgery have evolved over time and remarkable short- and long-term results have been re-ported. However, some concerns have emerged about the adequacy of myocardial protection dur-ing the minimally invasive approach and about the role of aortic clamping strategies in this contest.
Aim of this study was to compare the efficacy, in terms of myocardial protection, of the en-do-aortic clamp (EAC) versus the trans-thoracic aortic clamp (TTC) in patients undergoing right mini-thoracotomy MV repair.
A single center, prospective observational study was performed between June 2014 to June 2018 on patients undergoing right mini-thoracotomy MV repair with retrograde arterial perfusion and EAC or TTC. The selection of one setting in respect to the other was patient orientated. Myocardial protection was assessed through creatinine kinase-myocardial band (CK-MB) and cardiac Troponin T (cTn-T) blood levels immediately after the surgical procedure and at 6, 12, and 24 hours and compared between the two groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surgical indication for mitral valve repair.
- •Right mini-thoracotomy approach.
- •Retrograde arterial perfusion.
排除标准
- •Age more than 75 years.
- •Cardiac ejection fraction lower than 40%.
- •Previous cardiac surgery procedures for coronary artery bypass graft.
- •Any degree of coronary artery disease.
- •Severe peripheral vascular disease.
- •Concomitant procedures for atrial fibrillation ablation.
结局指标
主要结局
CK-MB levels immediately after surgery
时间窗: Immediately after the surgery
Myocardial protection was assessed through creatinine kinase-myocardial band (CK-MB) blood levels after right mini-thoracotomy mitral valve surgery and compared between the 2 groups of aortic clamping
cTn-T levels 6h
时间窗: hour 6 after surgery
Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping
cTn-T levels 12h
时间窗: hour 12 after surgery
Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping
CK-MB levels 6h
时间窗: hour 6 after surgery
Myocardial protection was assessed through creatinine kinase-myocardial band (CK-MB) blood levels after right mini-thoracotomy mitral valve surgery and compared between the 2 groups of aortic clamping
cTn-T levels immediately after surgery
时间窗: Immediately after surgery
Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping
CK-MB levels 12h
时间窗: hour 12 after surgery
(CK-MB) blood levels after right mini-thoracotomy mitral valve surgery and compared between the 2 groups of aortic clamping
cTn-T levels 24h
时间窗: hour 24 after surgery
Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping
CK-MB levels 24h
时间窗: hour 24 after surgery
Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping
次要结局
未报告次要终点
研究者
Cristina Barbero
MD, PhD, Cardio-thoracic Surgeon, Principal Investigator
University of Turin, Italy