Postcardiotomy Venoarterial Extracorporeal Membrane Oxygenation (PC-ECMO)

• ClinicalTrials.gov Identifier: NCT03508505
• Recruitment Status: Unknown
• First Posted: April 25, 2018
• Last Update Posted: March 11, 2020
• Sponsor: Turku University Hospital
• Collaborators: 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.
• Information provided by (Responsible Party): Turku University Hospital

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
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
• Estimated Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Postcardiotomy Venoarterial Extracorporeal Membrane Oxygenation
• Actual Study Start Date: January 1, 2018
• Estimated Primary Completion Date: June 30, 2020
• Estimated Study Completion Date: December 31, 2020

Groups and Cohorts

Intervention Details:

• 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.
  Other Names:

  • Cardiac surgery
  • Coronary artery bypass grafting
  • Aortic valve replacement
  • Mitral valve repair
  • Aortic surgery

Outcome Measures

Primary Outcome Measures :

1. Hospital death [ Time Frame: Up to 30 days after the index cardiac surgery ]
   All-cause death

Secondary Outcome Measures :

1. Late death [ Time Frame: Up to 7-year follow-up after the index cardiac surgery ]
   All-cause death
2. Stroke [ Time Frame: Up to 30 days after the index cardiac surgery ]
   Ischemic infarction or hemorrhagic injury of the brain
3. Tracheostomy [ Time Frame: Up to 30 days after the index cardiac surgery ]
   Respiratory failure requiring tracheostomy
4. Gastrointestinal complications [ Time Frame: Up to 30 days after the index cardiac surgery ]
   Gastrointestinal complications requiring surgical treatment
5. Deep sternal wound infection [ Time Frame: Up to 30 days after the index cardiac surgery ]
   Deep sternal wound infection or mediastinitis
6. Vascular access site infection [ Time Frame: Up to 30 days after the index cardiac surgery ]
   Infection secondary to any vascular access
7. Blood stream infection [ Time Frame: Up to 30 days after the index cardiac surgery ]
   Blood stream infection detected at blood cultures
8. Peripheral vascular injury [ Time Frame: 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 [ Time Frame: Up to 30 days after the index cardiac surgery ]
   Major lower limb amputation
10. New onset dialysis [ Time Frame: Up to 30 days after the index cardiac surgery ]
    New onset dialysis
11. Peak postoperative serum creatinine level [ Time Frame: Up to 30 days after the index cardiac surgery ]
    Peak postoperative serum creatinine level
12. Nadir postoperative pH during VA-ECMO [ Time Frame: Up to 30 days after the index cardiac surgery ]
    Nadir postoperative pH during VA-ECMO
13. Peak postoperative arterial lactate level [ Time Frame: Up to 30 days after the index cardiac surgery ]
    Peak postoperative arterial lactate level
14. Nadir postoperative hemoglobin level [ Time Frame: Up to 30 days after the index cardiac surgery ]
    Nadir postoperative hemoglobin level
15. Chest drainage output 24 h after surgery [ Time Frame: 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 [ Time Frame: Up to 30 days after the index cardiac surgery ]
    Number of red blood cells units transfused intra- and postoperatively
17. Reoperation for intrathoracic bleeding [ Time Frame: Up to 30 days after the index cardiac surgery ]
    Reoperation for intrathoracic bleeding
18. Reoperation for peripheral cannulation-related bleeding [ Time Frame: Up to 30 days after the index cardiac surgery ]
    Reoperation for peripheral cannulation-related bleeding
19. Intensive care unit length of stay [ Time Frame: Up to 30 days after the index cardiac surgery ]
    Intensive care unit length of stay
20. Death on VA-ECMO [ Time Frame: Up to 30 days after the index cardiac surgery ]
    Death on VA-ECMO

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Sampling Method: Non-Probability Sample

Study Population

Patients who required VA-ECMO for acute heart failure occurring during the index hopsitalization for elective, urgent or emergency adult cardiac surgery such as coronary surgery, heart valve surgery and/or aortic root surgery.

Criteria

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

Finland

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.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Biancari F, Perrotti A, Ruggieri VG, Mariscalco G, Dalen M, Dell'Aquila AM, Jonsson K, Ragnarsson S, Di Perna D, Bounader K, Gatti G, Juvonen T, Alkhamees K, Yusuff H, Loforte A, Lechiancole A, Chocron S, Pol M, Spadaccio C, Pettinari M, De Keyzer D, Fiore A, Welp H. Five-year survival after post-cardiotomy veno-arterial extracorporeal membrane oxygenation. Eur Heart J Acute Cardiovasc Care. 2021 Aug 24;10(6):595-601. doi: 10.1093/ehjacc/zuaa039.

Mariscalco G, Fiore A, Ragnarsson S, El-Dean Z, Jonsson K, Dalen M, Fux T, Ruggieri VG, Gatti G, Juvonen T, Zipfel S, Dell'Aquila AM, Perrotti A, Bounader K, Settembre N, Loforte A, Livi U, Pol M, Spadaccio C, Pettinari M, Reichart D, Alkhamees K, Welp H, Maselli D, Lichtenberg A, Biancari F; PC-ECMO group. Venoarterial Extracorporeal Membrane Oxygenation After Surgical Repair of Type A Aortic Dissection. Am J Cardiol. 2020 Jun 15;125(12):1901-1905. doi: 10.1016/j.amjcard.2020.03.012. Epub 2020 Mar 31.

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

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: Upon request, the investigators will ask the Ethical Committee of the participating centers for permission to share all individual participant data included in this registry with the exception of data through which the patients could be identified.

• 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; Heart Diseases; Cardiovascular Diseases