Postcardiotomy Venoarterial Extracorporeal Membrane Oxygenation

Cardiac Surgery Clinical Trial

— PC-ECMO  

Official title:

Postcardiotomy Venoarterial Extracorporeal Membrane Oxygenation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03508505
• Other study ID #: T3/2018
• Status: Active, not recruiting
• Start date: January 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2020
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2020
• Est. primary completion date: June 30, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Finland	Heart Center, Turku University Hospital	Turku

Sponsors (21)

Lead Sponsor

Collaborator

Turku University Hospital

CHU de Reims, Glenfield Hospital, Golden Jubilee National Hospital, Heinrich-Heine University, Duesseldorf, Helios Research Center, Helsinki University Central Hospital, Henri Mondor University Hospital, Institute for Clinical and Experimental Medicine, Karolinska Institutet, Lund University Hospital, Medical University of Vienna, Ospedali Riuniti Trieste, Prince Sultan Cardiac Center, Adult Cardiology Department., Rennes University Hospital, Sahlgrenska University Hospital, Sweden, St. Orsola Hospital, Universitätsklinikum Hamburg-Eppendorf, University Hospital Muenster, University Hospital, Udine, Italy, University of Burgundy

Country where clinical trial is conducted

Finland, 

Outcome

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