Postcardiotomy Venoarterial Extracorporeal Membrane Oxygenation
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Hospital death
研究概览
简要总结
Cardiac surgery can be not infrequently complicated by cardiac low-output syndrome due to critical preoperative conditions such as cardiogenic shock, poor left ventricular function and severe myocardial ischemia. Suboptimal myocardial protection, technical errors at graft anastomoses or of prosthesis implantation, and hibernating myocardium may further contribute to cardiac low-output syndrome occurring immediately or shortly after cardiac surgery. In this setting, veno-arterial extracorporeal oxygenation (VA-ECMO) is the only means to provide cardiopulmonary support to recovery or as bridge to transplantation.
Data on the real benefit of VA-ECMO after cardiac surgery is limited and often derived from heterogeneous patient populations, which prevent conclusive results on the benefits of VA-ECMO in this setting. This issue will be investigated in the present retrospective European multicenter study.
In this setting, veno-arterial extracorporeal oxygenation (VA-ECMO) is the only means to provide cardiopulmonary support to recovery or as bridge to transplantation.
Data on the real benefit of VA-ECMO after cardiac surgery is limited and often derived from heterogeneous populations of patients who underwent different cardiac procedures. Patients with cardiac low-output after surgery for aortic dissection or valve surgery are expected to have different baseline characteristics (such as age and comorbidities) and underlying cardiac disease than patients undergoing isolated coronary surgery. Furthermore, available studies included patients operated two decades ago and this does not provide an exact measure of the benefits of this treatment strategy.
The possible benefits of using VA-ECMO after adult cardiac surgery will be investigated in this retrospective European multicenter study.
详细描述
Cardiac surgery can be not infrequently complicated by cardiac low-output syndrome due to critical preoperative conditions such as cardiogenic shock, poor left ventricular function and severe myocardial ischemia. Prolonged aortic cross-clamping, ischemia-reperfusion injury, suboptimal myocardial protection, technical errors at graft anastomoses or of prosthesis implantation, and hibernating myocardium may further contribute to cardiac low-output syndrome occurring immediately or shortly after cardiac surgery. In this setting, veno-arterial extracorporeal oxygenation (VA-ECMO) is the only means to provide cardiopulmonary support to recovery or as bridge to transplantation.
Data on the real benefit of VA-ECMO after cardiac surgery is limited and often derived from heterogeneous and small size series of patients who underwent different cardiac surgery procedures. Patients with cardiac low-output after surgery for aortic dissection or valve surgery are expected to have different baseline characteristics (such as age and comorbidities) and underlying cardiac disease than patients undergoing isolated coronary surgery. Furthermore, available studies included patients operated two decades ago and, in view of the development of perfusion technology and perioperative care, this does not provide an exact measure of the current benefits of this treatment strategy. Importantly, the role of intra-aortic balloon pump, left ventricular venting, duration of VA-ECMO and hospital experience should be evaluated. The investigators sought to investigate these issues in a large multicenter study.
Patients and methods Patients who were treated with VA-ECMO for cardiac low-output after adult cardiac surgery (other than heart transplantation and/or implantation of a left ventricular assist device) in 21 centers of cardiac surgery from January 2010 to December 2017.
Eligibility criteria
- Patients aged > 18 years;
- Patients who required VA-ECMO after elective, urgent or emergency adult cardiac surgery such as coronary surgery, heart valve surgery and/or aortic root surgery because of postoperative low-cardiac output syndrome and/or acute respiratory failure.
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
- •Patients who required VA-ECMO after elective, urgent or emergency adult cardiac surgery such as coronary surgery, heart valve surgery and/or aortic root surgery.
排除标准
- •Any VA-ECMO implanted before index surgical procedure;
- •Patients who underwent postoperatively veno-venous ECMO;
- •Patients who required VA-ECMO after heart transplantation;
- •Patients who required VA-ECMO after any left ventricular assist device.
结局指标
主要结局
Hospital death
时间窗: Up to 30 days after the index cardiac surgery
All-cause death
次要结局
- Major lower limb amputation(Up to 30 days after the index cardiac surgery)
- Reoperation for intrathoracic bleeding(Up to 30 days after the index cardiac surgery)
- Intensive care unit length of stay(Up to 30 days after the index cardiac surgery)
- Nadir postoperative hemoglobin level(Up to 30 days after the index cardiac surgery)
- Stroke(Up to 30 days after the index cardiac surgery)
- Vascular access site infection(Up to 30 days after the index cardiac surgery)
- Tracheostomy(Up to 30 days after the index cardiac surgery)
- Gastrointestinal complications(Up to 30 days after the index cardiac surgery)
- Peak postoperative arterial lactate level(Up to 30 days after the index cardiac surgery)
- Deep sternal wound infection(Up to 30 days after the index cardiac surgery)
- Blood stream infection(Up to 30 days after the index cardiac surgery)
- Peripheral vascular injury(Up to 30 days after the index cardiac surgery)
- New onset dialysis(Up to 30 days after the index cardiac surgery)
- Nadir postoperative pH during VA-ECMO(Up to 30 days after the index cardiac surgery)
- Number of red blood cells units transfused intra- and postoperatively(Up to 30 days after the index cardiac surgery)
- Death on VA-ECMO(Up to 30 days after the index cardiac surgery)
- Late death(Up to 7-year follow-up after the index cardiac surgery)
- Peak postoperative serum creatinine level(Up to 30 days after the index cardiac surgery)
- Chest drainage output 24 h after surgery(Up to 24 hours after the index cardiac surgery)
- Reoperation for peripheral cannulation-related bleeding(Up to 30 days after the index cardiac surgery)