Continuous postoperative pericardial flushing reduces postoperative bleeding after coronary artery bypass grafting: A randomized trial

EClinicalMedicine, vol. 31, pp. 100661

Abstract

BACKGROUND: Prolonged or excessive bleeding after cardiac surgery can lead to a broad spectrum of secondary complications. One of the underlying causes is incomplete wound drainage, with subsequent accumulation of blood and clots in the pericardium. We developed the continuous postoperative pericardial flushing (CPPF) therapy to improve wound drainage and reduce postoperative blood loss and bleeding-related complications after cardiac surgery. This study compared CPPF to standard care in patients after coronary artery bypass grafting (CABG). METHODS: This is a single center, open label, randomized trial that enrolled patients at the Amsterdam UMC, location AMC, Amsterdam, the Netherlands. The study was registered at the 'Netherlands Trial Register', study identifier NTR5200 [1]. Adults undergoing CABG were randomly assigned to receive CPPF therapy or standard care, participants and investigators were not masked to group assignment. The primary end point was postoperative blood loss in the first 12-hours after surgery. FINDINGS: =≤0.001), with the remark that these results are overestimated due to a measurement error in part of the study group. None of patients in the study group required reoperation for non-surgical bleeding versus 3 (4%, 95% CI -0.4% to 7.0%) in the control group. None of the patients in the study group suffered from cardiac tamponade, versus 3 (4%, 95% CI -0,4% to 7.0%) in the control group. The incremental cost-effectiveness ratio was €116.513 (95% bootstrap CI €-882.068 to €+897.278). INTERPRETATION: The use of CPPF therapy after CABG seems to reduce bleeding and bleeding related complications. With comparable costs and no improvement in Qualty of Life (QoL), cost consideration for the implementation of CPPF is not relevant. None of the patients in the study group required re-interventions for non-surgical bleeding or acute cardiac tamponade, which underlines the proof of concept of this novel therapy. FUNDING: This study was funded by ZonMw, the Netherlands organization for health research and development (project 837001405).

Authors 11

1. Eva C Diephuis corresponding

   Amsterdam UMC Location University of Amsterdam · Amsterdam University Medical Centers

   Affiliation as printed

   Department of Cardiothoracic Surgery, Amsterdam University Medical Center, location AMC, Meibergdreef 9, Amsterdam, AZ 1105, Netherlands

2. Corianne A de Borgie

   University of Amsterdam

   Affiliation as printed

   Clinical Research Unit, University of Amsterdam, Amsterdam, Netherlands

3. Aeilko Having Zwinderman

   University of Amsterdam

   Affiliation as printed

   Clinical Research Unit, University of Amsterdam, Amsterdam, Netherlands

4. Jacobus A. Winkelman

   Amsterdam UMC Location University of Amsterdam · Amsterdam University Medical Centers

   Affiliation as printed

   Department of Cardiothoracic Surgery, Amsterdam University Medical Center, location AMC, Meibergdreef 9, Amsterdam, AZ 1105, Netherlands

5. Wim Jan van Boven

   Amsterdam UMC Location University of Amsterdam · Amsterdam University Medical Centers

   Affiliation as printed

   Department of Cardiothoracic Surgery, Amsterdam University Medical Center, location AMC, Meibergdreef 9, Amsterdam, AZ 1105, Netherlands

6. Josè P.S. Henriques

   Amsterdam UMC Location University of Amsterdam · Amsterdam University Medical Centers

   Affiliation as printed

   Department of Cardiology, Amsterdam University Medical Center, location AMC, Amsterdam, Netherlands

7. Susanne Eberl

   Amsterdam UMC Location University of Amsterdam · Amsterdam University Medical Centers

   Affiliation as printed

   Department of anesthesiology, Amsterdam University Medical Center, location AMC, Amsterdam, Netherlands

8. Nicole Petra Juffermans

   Amsterdam UMC Location University of Amsterdam · Amsterdam University Medical Centers

   Affiliation as printed

   Department of Intensive Care, Amsterdam University Medical Center, location AMC, Amsterdam, Netherlands

9. Marcus Josephus Schultz

   Mahidol University · Amsterdam UMC Location University of Amsterdam · University of Oxford · Mahidol Oxford Tropical Medicine Research Unit · Amsterdam University Medical Centers

   Affiliation as printed

   Department of Intensive Care, Amsterdam University Medical Center, location AMC, Amsterdam, Netherlands

   Mahidol-Oxford Tropical Medicine Research Unit (MORU), Mahidol University, Bangkok, Thailand

   Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom

10. Robert J.M. Klautz Aachen Department of Cardiothoracic Surgery

    Leiden University Medical Center · Amsterdam UMC Location University of Amsterdam · Amsterdam University Medical Centers

    Affiliation as printed

    Department of Cardiothoracic Surgery, Amsterdam University Medical Center, location AMC, Meibergdreef 9, Amsterdam, AZ 1105, Netherlands

    Department of Cardiothoracic Surgery, Leiden University Medical Center (LUMC), Leiden, Netherlands

11. David R. Koolbergen Aachen Department of Cardiothoracic Surgery

    Leiden University Medical Center · Amsterdam UMC Location University of Amsterdam · Amsterdam University Medical Centers

    Affiliation as printed

    Department of Cardiothoracic Surgery, Amsterdam University Medical Center, location AMC, Meibergdreef 9, Amsterdam, AZ 1105, Netherlands

    Department of Cardiothoracic Surgery, Leiden University Medical Center (LUMC), Leiden, Netherlands