PC-ECMO: Postcardiotomy Venoarterial Extracorporeal Membrane Oxygenation

• Sponsor: Turku University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03508505
• Collaborator: Karolinska Institutet (Other), Ospedali Riuniti Trieste (Other), Universitätsklinikum Hamburg-Eppendorf (Other), University of Burgundy (Other), CHU de Reims (Other), Rennes University Hospital (Other), Henri Mondor University Hospital (Other), Glenfield Hospital (Other), IRCCS Azienda Ospedaliero-Universitaria di Bologna (Other), University Hospital Muenster (Other), Institute for Clinical and Experimental Medicine (Other), Medical University of Vienna (Other), University Hospital, Udine, Italy (Other), Golden Jubilee National Hospital (Other), Heinrich-Heine University, Duesseldorf (Other), Helsinki University Central Hospital (Other), Helios Research Center (Other), Sahlgrenska University Hospital, Sweden (Other), Lund University Hospital (Other), Prince Sultan Cardiac Center, Adult Cardiology Department. (Other)
• Enrollment: 1,000
• Location: 1
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 27.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Heart Failure; Low Output Heart Failure; Cardiac Output, Low; Extracorporeal Membrane Oxygenation; Cardiac Surgery; Venoarterial Extracorporeal Membrane Oxygenation	Device: Venoarterial extracorporeal oxygenation

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 Design

• Study Type: Observational
• Anticipated Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Postcardiotomy Venoarterial Extracorporeal Membrane Oxygenation
• Actual Study Start Date: Jan 1, 2018
• Anticipated Primary Completion Date: Jun 30, 2020
• Anticipated Study Completion Date: Dec 31, 2020

Outcome Measures

Primary Outcome Measures

1. Hospital death [Up to 30 days after the index cardiac surgery]

   All-cause death

Secondary Outcome Measures

1. Late death [Up to 7-year follow-up after the index cardiac surgery]

   All-cause death

2. Stroke [Up to 30 days after the index cardiac surgery]

   Ischemic infarction or hemorrhagic injury of the brain

3. Tracheostomy [Up to 30 days after the index cardiac surgery]

   Respiratory failure requiring tracheostomy

4. Gastrointestinal complications [Up to 30 days after the index cardiac surgery]

   Gastrointestinal complications requiring surgical treatment

5. Deep sternal wound infection [Up to 30 days after the index cardiac surgery]

   Deep sternal wound infection or mediastinitis

6. Vascular access site infection [Up to 30 days after the index cardiac surgery]

   Infection secondary to any vascular access

7. Blood stream infection [Up to 30 days after the index cardiac surgery]

   Blood stream infection detected at blood cultures

8. Peripheral vascular injury [Up to 30 days after the index cardiac surgery]

   Any aortic and/or peripheral artery complications related to VA-ECMO

9. Major lower limb amputation [Up to 30 days after the index cardiac surgery]

   Major lower limb amputation

10. New onset dialysis [Up to 30 days after the index cardiac surgery]

    New onset dialysis

11. Peak postoperative serum creatinine level [Up to 30 days after the index cardiac surgery]

    Peak postoperative serum creatinine level

12. Nadir postoperative pH during VA-ECMO [Up to 30 days after the index cardiac surgery]

    Nadir postoperative pH during VA-ECMO

13. Peak postoperative arterial lactate level [Up to 30 days after the index cardiac surgery]

    Peak postoperative arterial lactate level

14. Nadir postoperative hemoglobin level [Up to 30 days after the index cardiac surgery]

    Nadir postoperative hemoglobin level

15. Chest drainage output 24 h after surgery [Up to 24 hours after the index cardiac surgery]

    Chest drainage output 24 h after surgery

16. 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

17. Reoperation for intrathoracic bleeding [Up to 30 days after the index cardiac surgery]

    Reoperation for intrathoracic bleeding

18. Reoperation for peripheral cannulation-related bleeding [Up to 30 days after the index cardiac surgery]

    Reoperation for peripheral cannulation-related bleeding

19. Intensive care unit length of stay [Up to 30 days after the index cardiac surgery]

    Intensive care unit length of stay

20. Death on VA-ECMO [Up to 30 days after the index cardiac surgery]

    Death on VA-ECMO

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Heart Center, Turku University Hospital	Turku		Finland	20521

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Turku University Hospital
• ClinicalTrials.gov Identifier: NCT03508505
• Other Study ID Numbers: T3/2018
• First Posted: Apr 25, 2018
• Last Update Posted: Mar 11, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Turku University Hospital: Acute Heart Failure; Low Output Heart Failure; Cardiac Low Output; Extracorporeal Membrane Oxygenation; ECMO; Venoarterial Extracorporeal membrane oxygenation; Cardiac Surgery
• Additional relevant MeSH terms: Heart Failure; Cardiac Output, Low

Study Results

No Results Posted as of Mar 11, 2020