Postcardiotomy Venoarterial Extracorporeal Membrane Oxygenation (PC-ECMO)

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.

Study Overview

• Status: Unknown
• Conditions: Extracorporeal Membrane Oxygenation; Cardiac Surgery; Acute Heart Failure; Cardiac Output, Low; Low Output Heart Failure; Venoarterial Extracorporeal Membrane Oxygenation
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• Finland
  • Turku, Finland, 20521
    • Heart Center, Turku University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: March 6, 2018
• First Submitted That Met QC Criteria: April 24, 2018
• First Posted (Actual): April 25, 2018

Study Record Updates

• Last Update Posted (Actual): March 11, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: ECMO; Cardiac Surgery; Acute Heart Failure; Extracorporeal Membrane Oxygenation; Low Output Heart Failure; Cardiac Low Output; Venoarterial Extracorporeal membrane oxygenation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Cardiac Output, Low
• Other Study ID Numbers: T3/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No