MiECC Versus Conventional Cardiopulmonary Bypass in Cardiac Surgery (MiECS)

Official title

Minimally Invasive Extracorporeal Circulation Versus Conventional Cardiopulmonary Bypass in Patients Undergoing Cardiac Surgery (MiECS): a Randomised Controlled Trial

Overview

MiECS is one of the largest multicentre randomised controlled trials on extracorporeal circulation conducted under the auspices of Minimal Invasive Extracorporeal Technologies International Society (MiECTiS). It is designed to ultimately address the emerging effectiveness of MiECC systems in the light of modern perfusion practice worldwide. The primary hypothesis is that MiECC, as compared to conventional CPB (cCPB), reduces the proportion of patients experiencing serious perfusion-related postoperative morbidity after cardiac surgery. The study will be led by the Clinical Research Unit of the Special Unit for Biomedical Research and Education (SUBRE), Aristotle University of Thessaloniki School of Medicine in Greece (AUSoM) with Chief Investigator Professor Kyriakos Anastasiadis, who is a key-opinion-leader in the field of MiECC, founder and Executive Board of MiECTiS.

Detailed description

Despite a fall in mortality rates over the past decade, patients having cardiac surgery continue to experience serious postoperative complications. The risk of serious and relatively common surgical complications is often a consequence of stopping the heart during the operation, using the heart and lung machine (conventional cardiopulmonary bypass; cCPB), and restarting and reperfusing the heart at the end of the operation. Although several strategies have been developed to reduce such complications, they still occur and can be life threatening; they also increase the length of time a patient spends in the hospital.

Miniaturised heart lung machines (minimally invasive extracorporeal circulation; MiECC) have been developed with the aim of reducing the number of postoperative complications arising from using cCPB. Because of the variety of miniaturised systems that have been evaluated, the different types of patients and outcomes investigated, and the poor quality of previous studies, the effectiveness of MiECC in reducing postoperative complications has not been established and most hospitals continue to use cCPB.

Our primary hypothesis is that, compared to cCPB, using a MiECC system during cardiac surgery reduces the proportion of patients having one of several serious postoperative complications (death, myocardial infarction, stroke, acute kidney injury, reintubation, tracheostomy, mechanical ventilation for more than 48 hours, or reoperation) up to 30 days after surgery. In addition, the investigators hypothesise that MiECC reduces the amount of blood products transfused, time to discharge from the cardiac intensive care unit and hospital and the health care resources used during the hospital stay.

Study investigators propose to carry out a large, multicentre randomised controlled trial in 10 to 15 cardiac surgery centres worldwide. Patients will be eligible if they are having coronary artery bypass surgery, aortic valve replace or both using a heart lung machine without circulatory arrest. Centres may recruit patients having all, or a subset of, operation types.

It is expected that 20 % to 23% of patients will experience one or more of the serious complications (the primary outcome). In order to be able confidently to detect a 30% relative reduction in the risk of this outcome, the investigators plan to recruit 1,300 participants across all sites.

Interventions

• Device Minimal Invasive Extracorporeal Circulation
  Cardiac surgery with Minimal Invasive Extracorporeal Circulation (MiECC).
• Device Conventional cardiopulmonary bypass
  Cardiac surgery with conventional cardiopulmonary bypass (cCPB).

Primary outcome measures

• Composite outcome of postoperative serious adverse events [Time frame: 30 days after randomization following the index admission]

Secondary outcome measures (12)

• All-cause mortality [Time frame: 30 days after randomization following the index admission]
• New-onset postoperative atrial fibrillation [Time frame: Through initial hospital admission from surgery to initial discharge from hospital, an average of 1 week.]
• Rate of red blood cells transfusion [Time frame: 30 days after randomization following the index admission]
• Rate of platelet transfusion [Time frame: 30 days after randomization following the index admission]
• Rate of fresh frozen plasma transfusion [Time frame: 30 days after randomization following the index admission]
• Rate of cryoprecipitate transfusion [Time frame: 30 days after randomization following the index admission]
• Activated Factor VII administration [Time frame: 30 days after randomization following the index admission]
• Fibrinogen administration [Time frame: 30 days after randomization following the index admission]
• Prothrombin complex concentrate administration [Time frame: 30 days after randomization following the index admission]
• Time to discharge from cardiac ICU [Time frame: Through initial hospital admission from surgery to initial discharge from hospital, an average of 1 week.]
• Time to discharge from hospital [Time frame: Through initial hospital admission from surgery to initial discharge from hospital, an average of 1 week.]
• Delirium [Time frame: Up to 5 days postoperatively]

Eligibility criteria

Inclusion criteria

• All patients undergoing any elective or urgent coronary artery bypass grafting (CABG), aortic valve replacement (AVR) or CABG+AVR surgery using extracorporeal circulation without circulatory arrest.

Exclusion criteria

• Requirement for emergency or salvage operation.
• Requirement for major aortic surgery (e.g. aortic root replacement).
• Contraindication or objection (e.g. Jehovah's Witnesses) to transfusion of blood products.
• Congenital or acquired platelet, red cell or clotting disorders (patients with iron deficient anaemia will not be excluded).
• Inability to give informed consent for the study (e.g. learning or language difficulties).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Germany · 3 centers

• Department of Cardiac Surgery — Coswig
• Department of Thoracic and Cardiovascular Surgery, University Medical Centre Goettingen — Göttingen
• Department of Cardiothoracic and Vascular Surgery, Ulm University Hospital — Ulm

Turkey (Türkiye) · 3 centers

• Department of Cardiovascular Surgery, Ankara City Hospital — Ankara
• Department of Cardiovascular Surgery, Izmir Bakırçay University, Faculty of Medicine — Izmir
• Department of Cardiovascular Surgery, Faculty of Medicine, Recep Tayyip Erdoğan University — Rize

United Kingdom · 3 centers

• Department of Cardiac Surgery, Royal Papworth Hospital — Cambridge
• Deparment of Cardiac Surgery, Castle Hill Hospital — Hull
• Department of Cardiothoracic Surgery, Hammersmith Hospital — London

Italy · 2 centers

• Department of Cardiac Surgery GVM Anthea Hospital — Bari
• Department of Cardiac Surgery GVM Maria Eleonora Hospital — Palermo

Canada · 1 center

• Perfusion Services University Health Network, Toronto General Hospital — Toronto

Greece · 1 center

• Cardiothoracic Department AHEPA University Hospital — Thessaloniki

Publications

• Anastasiadis K, Murkin J, Antonitsis P, Bauer A, Ranucci M, Gygax E, Schaarschmidt J, Fromes Y, Philipp A, Eberle B, Punjabi P, Argiriadou H, Kadner A, Jenni H, Albrecht G, van Boven W, Liebold A, de Somer F, Hausmann H, Deliopoulos A, El-Essawi A, Mazzei V, Biancari F, Fernandez A, Weerwind P, Puehler T, Serrick C, Waanders F, Gunaydin S, Ohri S, Gummert J, Angelini G, Falk V, Carrel T. Use of mi PMID 26819269
• Anastasiadis K, Antonitsis P, Asteriou C, Deliopoulos A, Argiriadou H. Modular minimally invasive extracorporeal circulation ensures perfusion safety and technical feasibility in cardiac surgery; a systematic review of the literature. Perfusion. 2022 Nov;37(8):852-862. doi: 10.1177/02676591211026514. Epub 2021 Jun 17. PMID 34137323
• COMICS investigators, The COMICS investigators. Conventional versus minimally invasive extracorporeal circulation in patients undergoing cardiac surgery: protocol for a randomised controlled trial (COMICS). Perfusion. 2021 May;36(4):388-394. doi: 10.1177/0267659120946731. Epub 2020 Aug 12. PMID 32781894
• Wahba A, Milojevic M, Boer C, De Somer FMJJ, Gudbjartsson T, van den Goor J, Jones TJ, Lomivorotov V, Merkle F, Ranucci M, Kunst G, Puis L; EACTS/EACTA/EBCP Committee Reviewers. 2019 EACTS/EACTA/EBCP guidelines on cardiopulmonary bypass in adult cardiac surgery. Eur J Cardiothorac Surg. 2020 Feb 1;57(2):210-251. doi: 10.1093/ejcts/ezz267. No abstract available. PMID 31576396
• Ranucci M, Johnson I, Willcox T, Baker RA, Boer C, Baumann A, Justison GA, de Somer F, Exton P, Agarwal S, Parke R, Newland RF, Haumann RG, Buchwald D, Weitzel N, Venkateswaran R, Ambrogi F, Pistuddi V. Goal-directed perfusion to reduce acute kidney injury: A randomized trial. J Thorac Cardiovasc Surg. 2018 Nov;156(5):1918-1927.e2. doi: 10.1016/j.jtcvs.2018.04.045. Epub 2018 Apr 18. PMID 29778331
• Anastasiadis K, Argiriadou H, Deliopoulos A, Antonitsis P. Minimal invasive extracorporeal circulation (MiECC): the state-of-the-art in perfusion. J Thorac Dis. 2019 Jun;11(Suppl 10):S1507-S1514. doi: 10.21037/jtd.2019.01.66. No abstract available. PMID 31293801
• Kowalewski M, Pawliszak W, Raffa GM, Malvindi PG, Kowalkowska ME, Zaborowska K, Kowalewski J, Tarelli G, Taggart DP, Anisimowicz L. Safety and efficacy of miniaturized extracorporeal circulation when compared with off-pump and conventional coronary artery bypass grafting: evidence synthesis from a comprehensive Bayesian-framework network meta-analysis of 134 randomized controlled trials involving PMID 26537755
• Anastasiadis K, Antonitsis P, Papazisis G, Haidich B, Liebold A, Punjabi P, Gunaydin S, El-Essawi A, Rao V, Serrick C, Condello I, Nasso G, Bozok S, Daylan A, Argiriadou H, Deliopoulos A, Karapanagiotidis G, Ashkanani F, Moorjani N, Cale A, Erdoes G, Bennett M, Starinieri P, Carrel T, Murkin J. Minimally invasive extracorporeal circulation versus conventional cardiopulmonary bypass in patients und PMID 39089011

Identifiers

NCT: NCT05487612 · MiECS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗