Postcardiotomy Venoarterial Extracorporeal Membrane Oxygenation

NCT03508505 | Unknown

• 1 other identifier: T3/2018
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Hospital death

  All-cause death

  Up to 30 days after the index cardiac surgery

Secondary Outcomes (20)

• Late death

  Up to 7-year follow-up after the index cardiac surgery

• Stroke

  Up to 30 days after the index cardiac surgery

• Tracheostomy

  Up to 30 days after the index cardiac surgery

• Gastrointestinal complications

  Up to 30 days after the index cardiac surgery

• Deep sternal wound infection

  Up to 30 days after the index cardiac surgery

Interventions

Venoarterial extracorporeal oxygenation DEVICE

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.

Also known as: Cardiac surgery, Coronary artery bypass grafting, Aortic valve replacement, Mitral valve repair, Aortic surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Heart Center, Turku University Hospital

Turku, 20521, Finland

Location

Related Publications (2)

• 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.

  PMID: 33580776 DERIVED

• 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.

  PMID: 32305219 DERIVED

MeSH Terms

Conditions

Cardiac Output, Low

Interventions

Extracorporeal Membrane Oxygenation; Cardiac Surgical Procedures; Coronary Artery Bypass; Transcatheter Aortic Valve Replacement; Mitral Valve Annuloplasty

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative; Cardiovascular Surgical Procedures; Thoracic Surgical Procedures; Myocardial Revascularization; Vascular Grafting; Vascular Surgical Procedures; Heart Valve Prosthesis Implantation; Prosthesis Implantation; Cardiac Valve Annuloplasty

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: April 25, 2018
• Study Start: January 1, 2018
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2020
• Last Updated: March 11, 2020

Record last verified: 2020-03

Locations

FI (1)