Auteurs:
Elettra Poli (Lausanne | CH)
Anna Bauer Dörries (Lausanne | CH)
Carlo Marcucci (Lausanne | CH)
Aurélien Roumy (Lausanne | CH)
Matthias Kirsch (Lausanne | CH)
Eleonora De Stefano (Lausanne | CH)
Lucas Liaudet (Lausanne | CH)
Antoine Schneider (Lausanne | CH)
Context and Objectives:
Cardiopulmonary bypass (CPB) is often associated with degrees of complex inflammatory response. This inflammatory reaction, sometimes referred to as “post-pump syndrome”, is characterized by activation of numerous inflammation pathways leading, in severe cases to systemic hypotension and organ dysfunction [1, 2]. Cytokine Hemoadsorption (HA) might therefore improve outcomes of patients undergoing cardiac surgery. In this randomized control trial (NCT02775123), we aim to evaluate the safety and efficacy of a cytokine HA on post-CPB inflammatory response in patients undergoing elective cardiac surgery and at risk of post-operative complications.
Methods:
30 patients undergoing elective cardiac surgery were randomly assigned either to standard CPB (control group, n = 15) or to CPB plus Cytosorb® (Cytosorbents, NJ, USA) (Cytosorb group, n = 15). Our primary outcome was levels of inflammatory cytokines (IL-1a, IL-1b, IL-2, IL-4, IL-5, IL-6, IL-10, TNF-alpha, IFN-gamma, MCP-1) measured at T0 (after induction of anaesthesia), T2 (end of CPB), T3 (6 hours after CPB initiation) and T4 (24 hours after CPB initiation).
Comparisons were made using chi-square and Wilcoxon signed-rank test. A p value < 0.05 was considered statistically significant.
Results
Baseline demographics and perioperative characteristics were similar between the two sets of patients: median age was 67 (49-77.5) years, EuroSCORE II 4.4 (2.3-8.2), LVEF 56 % (42.5-60.5) and 80% were male. Median CPB duration was 145 (116.5-199) minutes.
Procedures were coronary artery bypass graft (CABG) or single valve replacement (4/30), double valve replacement (2/30), CABG combined with valve replacement (8/30) and aortic root replacement (10/30), and other combined procedures (6/30).
There was no difference between the two groups in terms of need for any vasoconstrictor (p = 1.0), mean noradrenaline dose on the first post-operative day (p = 0.87), need for any inotrope (p = 0.682), duration of mechanical ventilation (p = 0.305), incidence of acute kidney injury (p = 1.0), intensive care unit (ICU) length of stay (p = 1.0), ICU and hospital mortality (both p = 1.0). Cytokine levels are still pending.
Conclusions
In this pilot study, HA with Cytosorb® during CPB was not associated with improved meaningful clinical outcomes. However, this study was initially powered to demonstrate a difference in cytokine levels. Such analyses are still pending.