Postcardiotomy Venoarterial Extracorporeal Membrane Oxygenation

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

• Registration Number: NCT03508505
• Lead Sponsor: Turku University Hospital

Brief Summary

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

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

1. Hospital death

2. Late death

3. Stroke

4. Tracheostomy

5. Gastrointestinal complications

6. Deep sternal wound infection

7. Vascular access site infection

8. Blood stream infection

9. Peripheral vascular injury

10. Major lower limb amputation

11. New onset dialysis

12. Peak postoperative serum creatinine level

13. Nadir postoperative pH during VA-ECMO

14. Peak postoperative arterial lactate level

15. Nadir postoperative hemoglobin level

16. Chest drainage output 24 h after surgery

17. Number of red blood cells units transfused intra- and postoperatively

18. Reoperation for intrathoracic bleeding

19. Reoperation for peripheral cannulation-related bleeding

20. Intensive care unit length of stay

21. Death on VA-ECMO

Analysis of clinical results

The aim of this registry is to perform a number of analysis evaluating:

1. Early and late survival of postcardiotomy VA-ECMO;

2. Predictors and causes of in-hospital death after successful weaning from postcardiotomy VA-ECMO;

3. Comparative analysis of peripheral versus central postcardiotomy VA-ECMO;

4. VA-ECMO plus intra-aortic baloon pump vs. isolated VA-ECMO;

5. 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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-03-06
• Study First Submitted QC: 2018-04-24
• Study First Posted: 2018-04-25
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-10
• Last Update Posted: 2020-03-11
• Primary Completion: 2020-06-30
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hospital death	Up to 30 days after the index cardiac surgery	All-cause death

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Heart Center, Turku University Hospital; 🇫🇮 Turku, Finland