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Postcardiotomy Venoarterial Extracorporeal Membrane Oxygenation

Postcardiotomy Venoarterial Extracorporeal Membrane Oxygenation

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03508505
Acronym
PC-ECMO
Enrollment
1000
Registered
2018-04-25
Start date
2018-01-01
Completion date
2020-12-31
Last updated
2020-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Acute Heart Failure, Low Output Heart Failure, Cardiac Low Output, Extracorporeal Membrane Oxygenation, ECMO, Venoarterial Extracorporeal membrane oxygenation, Cardiac Surgery

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.

Interventions

DEVICEVenoarterial 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.

Sponsors

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

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Hospital deathUp to 30 days after the index cardiac surgeryAll-cause death

Secondary

MeasureTime frameDescription
StrokeUp to 30 days after the index cardiac surgeryIschemic infarction or hemorrhagic injury of the brain
TracheostomyUp to 30 days after the index cardiac surgeryRespiratory failure requiring tracheostomy
Gastrointestinal complicationsUp to 30 days after the index cardiac surgeryGastrointestinal complications requiring surgical treatment
Deep sternal wound infectionUp to 30 days after the index cardiac surgeryDeep sternal wound infection or mediastinitis
Vascular access site infectionUp to 30 days after the index cardiac surgeryInfection secondary to any vascular access
Blood stream infectionUp to 30 days after the index cardiac surgeryBlood stream infection detected at blood cultures
Peripheral vascular injuryUp to 30 days after the index cardiac surgeryAny aortic and/or peripheral artery complications related to VA-ECMO
Major lower limb amputationUp to 30 days after the index cardiac surgeryMajor lower limb amputation
New onset dialysisUp to 30 days after the index cardiac surgeryNew onset dialysis
Late deathUp to 7-year follow-up after the index cardiac surgeryAll-cause death
Nadir postoperative pH during VA-ECMOUp to 30 days after the index cardiac surgeryNadir postoperative pH during VA-ECMO
Peak postoperative arterial lactate levelUp to 30 days after the index cardiac surgeryPeak postoperative arterial lactate level
Nadir postoperative hemoglobin levelUp to 30 days after the index cardiac surgeryNadir postoperative hemoglobin level
Chest drainage output 24 h after surgeryUp to 24 hours after the index cardiac surgeryChest drainage output 24 h after surgery
Number of red blood cells units transfused intra- and postoperativelyUp to 30 days after the index cardiac surgeryNumber of red blood cells units transfused intra- and postoperatively
Reoperation for intrathoracic bleedingUp to 30 days after the index cardiac surgeryReoperation for intrathoracic bleeding
Reoperation for peripheral cannulation-related bleedingUp to 30 days after the index cardiac surgeryReoperation for peripheral cannulation-related bleeding
Intensive care unit length of stayUp to 30 days after the index cardiac surgeryIntensive care unit length of stay
Death on VA-ECMOUp to 30 days after the index cardiac surgeryDeath on VA-ECMO
Peak postoperative serum creatinine levelUp to 30 days after the index cardiac surgeryPeak postoperative serum creatinine level

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026