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Table 2 Evidence overview – elective complex cardiac surgery (various procedures with prolonged CPB)

From: The role of hemoadsorption in cardiac surgery – a systematic review

No

Study

Study

design

Device

Interventions

Controls

Results of the intervention

1

2016

Bernardi, M. H., et al. [15]

Prospective

RCT

CytoSorb®

(intra-op on CPB)

19

18

No significant difference in primary outcome—cytokine levels (IL-1ß, IL-6, IL-18, TNF-⍺), except for IL-10

2

2019

Bernardi, M. H., et al. [18]

Prospective

RCT

(post hoc subgroup analysis of No. 1)

CytoSorb®

(intra-op on CPB)

17

18

Significantly:

- higher haptoglobin (primary outcome)

- lower LDH

No significant difference between the groups in levels of plasma-free hemoglobin (primary outcome) and total bilirubin

3

2019

Garau, I., et al. [19]

Prospective

RCT

CytoSorb®

(intra-op on CPB)

20

20

Significantly:

- lower cytokine levels (IL-8, TNF-⍺)—primary outcome

- higher CI

No significant difference in levels of IL-6 (primary outcome)

4

2019

Gleason, T. G., et al. [20]

Prospective

RCT

2 CytoSorb®

(intra-op on CPB)

23

23

Significant reduction in:

- plasma-free hemoglobin (primary outcome)

- activated complement C3a & C5a

5

2019

Poli, E. C., et al. [21]

Prospective

RCT

CytoSorb®

(intra-op on CPB)

15

15

No significant difference in primary outcome—cytokine levels (IL-1a, IL-1b, IL-2, IL-4, IL-5, IL-6, IL-10, TNF-α, IFN-γ, MCP-1), as well as in clinical outcomes

Significantly lower activity of coagulation factors II and XII

6

2019

Wagner, R., et al. [22]

Prospective

RCT

CytoSorb®

(intra-op on CPB)

15

13

Significantly higher level of miRNA-133 – primary outcome

No significant differences in levels of miRNA-1, miRNA-126, and miRNA-223 (primary outcomes), as well as in clinical outcomes

7

2019

Taleska-Stupica, G., et al. [23]

Prospective

RCT

CytoSorb®

(intra-op on CPB)

20

20

&

20a

Significantly:

- higher CD64 and CD163 antigen expression on immune cells

- increased activated complement C5a (primary outcomes)

No significant difference in primary outcome—cytokine levels (TNF-α, IL-1β, IL-6, IL-8, and IL-10)

8

2020

Wisgrill, L., et al. [24]

Prospective

RCT

(post hoc subgroup analysis of No. 1)

CytoSorb®

(intra-op on CPB)

9

9

No significant differences in circulating microvesicles, apoptotic body counts and kinetics

9

2021

Hohn, A., et al. [16]

Prospective

Case series

(part of the ongoing RECCASb study)

CytoSorb®

(intra-op on CPB)

15

/

Significant, pre- vs post-adsorber:

- reduction of heparan sulphate

- increase of hyaluronan

10

2022

Manohar, M., et al. [17]

Retrospective

Case–control

CytoSorb®

(intra-op on CPB)

23

29

Significantly lower:

- increase of VIS from pre- to postoperative value (primary outcome)

Notably lower:

- in-hospital mortality

  1. CPB Cardiopulmonary bypass, RCT Randomized controlled trial, IL Interleukin, TNF Tumor necrosis factor, LDH Lactate dehydrogenase, CI Cardiac index, IFN Interferon, MCP Monocyte chemoattractant protein, miRNA Micro ribonucleic acid, VIS Vasoactive-inotropic score
  2. aThree groups, 20 given intraoperative methylprednisolone, 20 intraoperative CytoSorb®, 20 controls; results shown for comparison between hemoadsorption and controls
  3. bGerman Clinical Trials Register number DRKS00007928 (Date of registration August 3rd, 2015)