Clinical trial NCT03508505: Postcardiotomy Venoarterial Extracorporeal Membrane Oxygenation
Official title: Postcardiotomy Venoarterial Extracorporeal Membrane Oxygenation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Heart Failure
Low Output Heart Failure
Cardiac Output, Low
Extracorporeal Membrane Oxygenation
Cardiac Surgery
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
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Karolinska Institutet
name: Ospedali Riuniti Trieste
name: Universitätsklinikum Hamburg-Eppendorf
name: University of Burgundy
name: CHU de Reims
name: Rennes University Hospital
name: Henri Mondor University Hospital
name: Glenfield Hospital
name: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: University Hospital Muenster
name: Institute for Clinical and Experimental Medicine
name: Medical University of Vienna
name: University Hospital, Udine, Italy
name: Golden Jubilee National Hospital
name: Heinrich-Heine University, Duesseldorf
name: Helsinki University Central Hospital
name: Helios Research Center
name: Sahlgrenska University Hospital
name: Lund University Hospital
name: Prince Sultan Cardiac Center, Adult Cardiology Department.
First posted: 2018-04-25
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Hospital death
timeFrame: Up to 30 days after the index cardiac surgery
Secondary outcomes:
measure: Late death
timeFrame: Up to 7-year follow-up after the index cardiac surgery
measure: Stroke
timeFrame: Up to 30 days after the index cardiac surgery
measure: Tracheostomy
timeFrame: Up to 30 days after the index cardiac surgery
measure: Gastrointestinal complications
timeFrame: Up to 30 days after the index cardiac surgery
measure: Deep sternal wound infection
timeFrame: Up to 30 days after the index cardiac surgery
measure: Vascular access site infection
timeFrame: Up to 30 days after the index cardiac surgery
measure: Blood stream infection
timeFrame: Up to 30 days after the index cardiac surgery
measure: Peripheral vascular injury
timeFrame: Up to 30 days after the index cardiac surgery
measure: Major lower limb amputation
timeFrame: Up to 30 days after the index cardiac surgery
measure: New onset dialysis
timeFrame: Up to 30 days after the index cardiac surgery
measure: Peak postoperative serum creatinine level
timeFrame: Up to 30 days after the index cardiac surgery
measure: Nadir postoperative pH during VA-ECMO
timeFrame: Up to 30 days after the index cardiac surgery
measure: Peak postoperative arterial lactate level
timeFrame: Up to 30 days after the index cardiac surgery
measure: Nadir postoperative hemoglobin level
timeFrame: Up to 30 days after the index cardiac surgery
measure: Chest drainage output 24 h after surgery
timeFrame: Up to 24 hours after the index cardiac surgery
measure: Number of red blood cells units transfused intra- and postoperatively
timeFrame: Up to 30 days after the index cardiac surgery
measure: Reoperation for intrathoracic bleeding
timeFrame: Up to 30 days after the index cardiac surgery
measure: Reoperation for peripheral cannulation-related bleeding
timeFrame: Up to 30 days after the index cardiac surgery
measure: Intensive care unit length of stay
timeFrame: Up to 30 days after the index cardiac surgery
measure: Death on VA-ECMO
timeFrame: Up to 30 days after the index cardiac surgery
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Heart Center, Turku University Hospital
Study officials:
References:
citation: 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.
citation: 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.