Extracorporeal Hemadsorption versus Glucocorticoids during Cardiopulmonary Bypass: A Prospective, Randomized, Controlled Trial

Abstract

Extracorporeal hemadsorption may reduce inflammatory reaction in cardiopulmonary bypass (CPB) surgery. Glucocorticoids have been used during open-heart surgery for alleviation of systemic inflammation after CPB. We compared intraoperative hemadsorption and methylprednisolone, with usual care, during complex cardiac surgery on CPB, for inflammatory responses, hemodynamics, and perioperative course. Seventy-six patients with prolonged CPB were recruited and randomized, with 60 included in final analysis. Allocation was into three groups: Methylprednisolone (n = 20), Cytosorb (n = 20), and Control group (usual care, n = 20). Proinflammatory (TNF-α, IL-1β, IL-6, and IL-8) and anti-inflammatory (IL-10) cytokines which complement C5a, CD64, and CD163 expression by immune cells were analyzed within the first five postoperative days, in addition to hemodynamic and clinical outcome parameters. Methylprednisolone group, compared to Cytosorb and Control had significantly lower levels of TNF-α (until the end of surgery, p<0.001), IL-6 (until 48 h after surgery, p<0.001), and IL-8 (until 24 h after surgery, p<0.016). CD64 expression on monocytes was the highest in the Cytosorb group and lasted until the 5th postoperative day (p<0.016). IL-10 concentration (until the end of surgery) and CD163 expression on monocytes (until 48 h after surgery) were the highest in the Methylprednisolone group (p<0.016, for all measurements between three groups). No differences between groups in the cardiac index or clinical outcome parameters were found. Methylprednisolone more effectively ameliorates inflammatory responses after CPB surgery compared to hemadsorption and usual care. Hemadsorption compared with usual care causes higher prolonged expression of CD64 on monocytes but short lasting expression of CD163 on granulocytes. Hemadsorption with CytoSorb® was safe and well tolerated. This trial is registered with clinicaltrials.gov (NCT02666703).

Initial experience with CytoSorb therapy in patients receiving left ventricular assist devices

“…Our results show no significant difference in mortality and overall survival with the use of CytoSorb in LVAD implantation. Taleska Stupica et al also reported 1‐year mortality of their patients receiving CytoSorb not be significantly different when compared to the control group 14 . Nevertheless, unlike the previously mentioned randomized control trials, we found that patients treated with CytoSorb were more likely to develop respiratory failure, need mechanical ventilation for longer than 6 days post‐implant, and require tracheostomy during hospitalization.…”

Application of Adsorptive Blood Purification Techniques during Cardiopulmonary Bypass in Cardiac Surgery

“…There are one systematic review [ 67 ], one multicenter RCT [ 68 ], five single-center RCTs (one ongoing) [ 69 – 73 ], and three related published studies [ 74 – 76 ]. In the systematic review published in 2021, except two RCTs investigating the application of extracorporeal cytokine adsorption therapy as a therapeutic add-on treatment in sepsis or septic shock, the other five RCTs investigated the application of CytoSorb as a preventive measure in cardiac surgery from 2016 to 2019.…”

Case Report: Emergency CABG Following Failure of PTCA in a COVID-19 Patient

“…Systemic corticosteroids may have a potential pivotal role in the management of these patients; as reported by Xiang et al ( 22 ) they improve severe COVID-19 by reducing IL-6 levels and activating ACE2. Interesting findings from a randomized control trial evidenced the effectiveness of corticosteroids during CPB to reduced IL-6 expression ( p < 0.001) until 48 h after surgery compared to controls and extracorporeal hemadsorption ( 23 ). Others anti-inflammatory strategies, in severe COVID-19 undergoing cardiac surgery, could be the use of leukodepleting filters or IABP-induced pulsatile perfusion ( 24 , 25 ) as in the past the use of technical alterations such as heparin coating of the CPB circuit ( 26 ).…”