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Minimally invasive extracorporeal circulation versus conventional cardiopulmonary bypass in patients undergoing cardiac surgery (MiECS): Rationale and design of a multicentre randomised trial.
Anastasiadis, Kyriakos; Antonitsis, Polychronis; Papazisis, Georgios; Haidich, Bettina; Liebold, Andreas; Punjabi, Prakash; Gunaydin, Serdar; El-Essawi, Aschraf; Rao, Vivek; Serrick, Cyril; Condello, Ignazio; Nasso, Giuseppe; Bozok, Sahin; Daylan, Ahmet; Argiriadou, Helena; Deliopoulos, Apostolos; Karapanagiotidis, Georgios; Ashkanani, Fatma; Moorjani, Narain; Cale, Alex; Erdoes, Gabor; Bennett, Mark; Starinieri, Pascal; Carrel, Thierry; Murkin, John.
Afiliação
  • Anastasiadis K; Cardiothoracic Department, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.
  • Antonitsis P; Cardiothoracic Department, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.
  • Papazisis G; Special Unit for Biomedical Research and Education, Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece.
  • Haidich B; Department of Hygiene, Social-Preventive Medicine and Medical Statistics, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.
  • Liebold A; Department of Cardio-thoracic Surgery, University Hospital Ulm, Ulm, Germany.
  • Punjabi P; Department of Cardiothoracic Surgery, Hammersmith Hospital, Imperial College Healthcare NHS Trust, London, UK.
  • Gunaydin S; Department of Cardiovascular Surgery, Ankara City Hospital, University of Health Sciences, Ankara, Turkey.
  • El-Essawi A; Department of Thoracic and Cardiovascular Surgery, University Medical Center Göttingen, Göttingen, Germany.
  • Rao V; Peter Munk Cardiac Centre, Toronto General Hospital, Toronto, ON, Canada.
  • Serrick C; Peter Munk Cardiac Centre, Toronto General Hospital, Toronto, ON, Canada.
  • Condello I; Cardiac Surgery, Anthea Hospital Gvm Care & Research, Bari, Italy.
  • Nasso G; Cardiac Surgery, Anthea Hospital Gvm Care & Research, Bari, Italy.
  • Bozok S; Department of Cardiovascular Surgery, Izmir Bakircay University, Izmir, Turkey.
  • Daylan A; Department of Cardiovascular Surgery, Izmir Bakircay University, Izmir, Turkey.
  • Argiriadou H; Cardiothoracic Department, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.
  • Deliopoulos A; Cardiothoracic Department, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.
  • Karapanagiotidis G; Cardiothoracic Department, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.
  • Ashkanani F; Department of Cardio-thoracic Surgery, University Hospital Ulm, Ulm, Germany.
  • Moorjani N; Department of Cardiothoracic Surgery, Royal Papworth Hospital, University of Cambridge, Cambridge, UK.
  • Cale A; Department of Cardiac Surgery, Hull and East Yorkshire Hospitals NHS Trust, Hull, UK.
  • Erdoes G; Department of Anesthesiology and Pain Medicine, Inselspital, Bern University Hospital, Bern, Switzerland.
  • Bennett M; Department of Anesthesia, Morriston Hospital, Swansea Bay University Health Board, Swansea, UK.
  • Starinieri P; Department of Clinical Perfusion, Jessa Hospital, Hasselt, Belgium.
  • Carrel T; Department of Cardiac Surgery, University Hospital Zürich, Switzerland.
  • Murkin J; Department of Anesthesia and Perioperative Medicine, Schulich School of Medicine and Dentistry, University of Western Ontario, London, ON, Canada.
Perfusion ; : 2676591241272009, 2024 Aug 01.
Article em En | MEDLINE | ID: mdl-39089011
ABSTRACT

INTRODUCTION:

The ultimate answer to the question whether minimal invasive extracorporeal circulation (MiECC) represents the optimal perfusion technique in contemporary clinical practice remains elusive. The present study is a real-world study that focuses on specific perfusion-related clinical outcomes after cardiac surgery that could potentially be favourably affected by MiECC and thereby influence the future clinical practice.

METHODS:

The MiECS study is an international, multi-centre, two-arm randomized controlled trial. Patients undergoing elective or urgent coronary artery bypass grafting (CABG), aortic valve replacement (AVR) or combined procedure (CABG + AVR) using extracorporeal circulation will be randomized to MiECC or contemporary conventional cardiopulmonary bypass (cCPB). Use of optimized conventional circuits as controls is acceptable. The study design includes a range of features to prevent bias and is registered at clinicaltrials.gov (NCT05487612).

RESULTS:

The primary outcome is a composite of postoperative serious adverse events that could be related to perfusion technique occurring up to 30 days postoperatively. Secondary outcomes include use of blood products, ICU and hospital length of stay (30 days) as well as health-related quality of life (30 and 90 days).

CONCLUSIONS:

The MiECS trial has been designed to overcome perceived limitation of previous trials of MiECC. Results of the proposed study could affect current perfusion practice towards advancement of patient care.
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Texto completo: 1 Base de dados: MEDLINE Idioma: En Revista: Perfusion Assunto da revista: CARDIOLOGIA Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Grécia

Texto completo: 1 Base de dados: MEDLINE Idioma: En Revista: Perfusion Assunto da revista: CARDIOLOGIA Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Grécia