Postcardiotomy Venoarterial Extracorporeal Membrane Oxygenation

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Exclusion criteria Patients aged < 18 years; 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. Definition criteria Definition criteria and units of measurements are reported beside each baseline, operative and postoperative variables in the electronic datasheet. Outcomes Hospital death Late death Stroke Tracheostomy Gastrointestinal complications Deep sternal wound infection Vascular access site infection Blood stream infection Peripheral vascular injury Major lower limb amputation New onset dialysis Peak postoperative serum creatinine level Nadir postoperative pH during VA-ECMO Peak postoperative arterial lactate level Nadir postoperative hemoglobin level Chest drainage output 24 h after surgery Number of red blood cells units transfused intra- and postoperatively Reoperation for intrathoracic bleeding Reoperation for peripheral cannulation-related bleeding Intensive care unit length of stay Death on VA-ECMO Analysis of clinical results The aim of this registry is to perform a number of analysis evaluating: Early and late survival of postcardiotomy VA-ECMO; Predictors and causes of in-hospital death after successful weaning from postcardiotomy VA-ECMO; Comparative analysis of peripheral versus central postcardiotomy VA-ECMO; VA-ECMO plus intra-aortic baloon pump vs. isolated VA-ECMO; Determinants of outcome after prolonged postcardiotomy VA-ECMO (>5 days). Publication of results The results of these studies will be submitted for publication to international, peer-reviewed journals in the fields of critical care, cardiology or cardiac surgery.

Official Title
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Postcardiotomy Venoarterial Extracorporeal Membrane Oxygenation

Conditions
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Acute Heart Failure, Low Output Heart Failure, Cardiac Output, Low, Extracorporeal Membrane Oxygenation, Cardiac Surgery, Venoarterial Extracorporeal Membrane Oxygenation

Intervention / Treatment
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* Device: Venoarterial extracorporeal oxygenation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Venoarterial extracorporeal oxygenation|Veno-arterial extracorporeal oxygenation (VA-ECMO) is inserted in the acute setting in case of cardiac low output after adult cardiac surgery in order to provide cardiopulmonary support to recovery or as bridge to transplantation.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital death | All-cause death | Up to 30 days after the index cardiac surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late death | All-cause death | Up to 7-year follow-up after the index cardiac surgery | 
| Stroke | Ischemic infarction or hemorrhagic injury of the brain | Up to 30 days after the index cardiac surgery | 
| Tracheostomy | Respiratory failure requiring tracheostomy | Up to 30 days after the index cardiac surgery | 
| Gastrointestinal complications | Gastrointestinal complications requiring surgical treatment | Up to 30 days after the index cardiac surgery | 
| Deep sternal wound infection | Deep sternal wound infection or mediastinitis | Up to 30 days after the index cardiac surgery | 
| Vascular access site infection | Infection secondary to any vascular access | Up to 30 days after the index cardiac surgery | 
| Blood stream infection | Blood stream infection detected at blood cultures | Up to 30 days after the index cardiac surgery | 
| Peripheral vascular injury | Any aortic and/or peripheral artery complications related to VA-ECMO | Up to 30 days after the index cardiac surgery | 
| Major lower limb amputation | Major lower limb amputation | Up to 30 days after the index cardiac surgery | 
| New onset dialysis | New onset dialysis | Up to 30 days after the index cardiac surgery | 
| Peak postoperative serum creatinine level | Peak postoperative serum creatinine level | Up to 30 days after the index cardiac surgery | 
| Nadir postoperative pH during VA-ECMO | Nadir postoperative pH during VA-ECMO | Up to 30 days after the index cardiac surgery | 
| Peak postoperative arterial lactate level | Peak postoperative arterial lactate level | Up to 30 days after the index cardiac surgery | 
| Nadir postoperative hemoglobin level | Nadir postoperative hemoglobin level | Up to 30 days after the index cardiac surgery | 
| Chest drainage output 24 h after surgery | Chest drainage output 24 h after surgery | Up to 24 hours after the index cardiac surgery | 
| Number of red blood cells units transfused intra- and postoperatively | Number of red blood cells units transfused intra- and postoperatively | Up to 30 days after the index cardiac surgery | 
| Reoperation for intrathoracic bleeding | Reoperation for intrathoracic bleeding | Up to 30 days after the index cardiac surgery | 
| Reoperation for peripheral cannulation-related bleeding | Reoperation for peripheral cannulation-related bleeding | Up to 30 days after the index cardiac surgery | 
| Intensive care unit length of stay | Intensive care unit length of stay | Up to 30 days after the index cardiac surgery | 
| Death on VA-ECMO | Death on VA-ECMO | Up to 30 days after the index cardiac surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Heart Failure, Low Output Heart Failure, Cardiac Low Output, Extracorporeal Membrane Oxygenation, ECMO, Venoarterial Extracorporeal membrane oxygenation, Cardiac Surgery