Support your cardiovascular patients
Complex cardiac surgeries involving CPB can be associated with a dysregulated immune response, which may contribute to complications such as vasoplegic shock and multi-organ dysfunction. Emergency cardiac surgeries in patients receiving antithrombotic drugs such as ticagrelor or rivaroxaban may carry an increased risk of perioperative bleeding.
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Intraoperative Use of CytoSorb®
The use of CytoSorb® during surgery is intended for the adsorptive removal of selected antithrombotic agents such as ticagrelor and rivaroxaban within the approved indications, and to support the management of postoperative inflammatory responses.
The therapy is designed to adsorb selected cytokines and inflammatory mediators, aiming to help maintain physiological balance during complex procedures such as heart transplantation, aortic surgery, or infective endocarditis surgery, as part of a multimodal treatment concept.
Intraoperative use of CytoSorb® is intended to support hemodynamic stabilization in high-risk surgical settings. -
Postoperative Use of CytoSorb®
In the postoperative setting, CytoSorb® technology is intended to support hemodynamic stabilization in patients experiencing systemic hyperinflammatory responses associated with shock and circulatory instability. By adsorbing selected inflammatory mediators from blood, the therapy aims to assist in supporting physiological balance as part of a multimodal treatment approach.
CytoSorb® can be applied in various cardiovascular indications
Support hemostatic control in urgent surgeries
Intraoperative use of CytoSorb® is intended for the removal of ticagrelor and rivaroxaban during cardiopulmonary bypass, aiming to support hemostatic management during urgent surgical interventions.
Managing bleeding risk in urgent cardiac surgery
In urgent or emergency cardiac surgery, patients receiving antithrombotic therapy may face an increased risk of perioperative bleeding when insufficient time is available for pharmacological wash-out.
This is particularly relevant for procedures performed under dual antiplatelet therapy or DOAC therapy such as ticagrelor or rivaroxaban.
By removing ticagrelor and rivaroxaban during cardiopulmonary bypass surgery, CytoSorb® has been reported in clinical experience to support perioperative management, including reduction of drug levels.
Reduced operation time
Reduced RBC transfusion
Reduced PLT transfusion
Reduced re-thoracotomy rates
Reduced ICU length of stay
Reduced drainage volume
Drainage volume
CytoSorb® provides significant reduction in drainage volume
The 24-hours drainage volume was significantly lower in adsorber-treated patients; patients on with ticagrelor and rivaroxaban and with (right side) and without (left side) hemadsorption.
Hassan K et al., Ann Thorac Cardiovasc Surg. 2022 28(3):186-192
Cost effectiveness
CytoSorb Therapy provides significant cost savings over standard of care across several healthcare systems (1-2)
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Healthcare system
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| Overall cost saving vs Standard of care | £3,941 (1) | €4,200 ± 1,100 (2) |
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- Javanbakht et al., Pharmacoecon Open 2020; 4(2):307-319
- Hassan et al., Presented at ESC Congress, Barcelona Spain, August 2022: 1279
Best practice therapy management
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Therapeutic goal
Reduction of bleeding complications, blood product use, and length of ICU stay
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Patient selection
Patients undergoing cardiac surgery who were pretreated with ticagrelor and / or rivaroxaban, with last dose of Ticagrelor < 72 hrs. and Rivaroxaban < 48 hrs.
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Timing
Start therapy with the start of CPB. CytoSorb® is easily integrated into the CPB circuit (post-pump to venous reservoir)
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Dosing
Postoperative continuation (with a new adsorber integrated into an extracorporeal circuit) is normally NOT needed if CPB time > 60 min, but can be done if needed.
Support surgical care and inflammatory control
Major surgery with CPB can be associated with postoperative inflammatory responses that may contribute to complications.
Support management in infective-endocarditis surgery
Although infective-endocarditis surgery is a curative intervention, it can be associated with bacterial dissemination and immune activation, potentially contributing to hemodynamic instability and multi-organ dysfunction.
Clinical reports have described reduced cytokine levels, modulation of inflammatory mediators, and improved hemodynamic parameters in selected cases.
Potential clinical observations in infective-endocarditis surgery:
Promotion of hemodynamic stability
Reduction in length of ICU stays
Reduction in vasopressors needs
Reduction in sepsis and sepsis-related mortality
Reduction in mortality in patients infected with Staphylococcus aureus
Infective Endocarditis
Treatment Rationale & Guidance
Improve your surgical outcomes. Remove excessive cytokines and PAMPs/DAMPs. Eliminate toxins and hemolysins. Prevent and reverse systemic inflammation. Stabilize micro- and macro-hemodynamics. Preserve and restore organ function.
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Reduce endothelial-damaging proteins, toxins, and hemolysins
Kalisnik et al.Adsorption of excessive cytokines and other inflammatory mediators, PAMPs and DAMPs
In cases of “hot” endocarditis, patients may present with systemic inflammation and hemodynamic instability. Published literature has discussed adsorption of certain inflammatory mediators and proteins, which may support management in high-risk patients.
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Improve capillary leakage / Reduce pathogenicity (e.g. S. aureus)
Piskovatska et al.Adsorption of endothelial-associated proteins
The “leaky bucket” phenomenon describes endothelial disruption and tissue edema. Selected cytokines and proteins associated with this process have been reported to be adsorbed by CytoSorb® in clinical and experimental studies.
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Micro- and macro-circulatory management
Holmen et al.Support of hemodynamic stabilization
Capillary leakage may impair perfusion and oxygenation. CytoSorb® is intended to support hemodynamic stabilization as part of multimodal care.
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Support SoC and postoperative recovery
Haidari et al.Keep immune response in balance
Clinical experience has reported reduced postoperative vasopressor and fluid requirements in selected patients, potentially contributing to overall stabilization.
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Support and maintain organ function
Rao et al.Support recovery and enable efficient postoperative management
Improved intra- and postoperative stability reported in clinical experience may support recovery and complement standard-of-care treatment, potentially allowing more efficient ICU resource use.
Support aortic surgery patients
Complex aortic surgery can be associated with dysregulated immune responses and complications such as vasoplegic shock or multi-organ dysfunction.
CytoSorb® Therapy is designed to reduce elevated levels of selected cytokines, aiming to support hemodynamic stability and assist in managing hyperinflammatory conditions during and after surgery.
CytoSorb Therapy can help to:
Attenuate hyperinflammation
Improve pulmonary function
Promote hemodynamic stability
Reduce blood product use
Reduce vasopressor needs
Aortic surgery
Treatment Rationale & Guidance
Protect your aortic surgery patient. Remove excessive cytokines and DAMPs. Manage additional bleeding risk through removal of antithrombotics. Stabilize micro- and macro-hemodynamics. Preserve and restore organ function.
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Protect your Aortic Surgery patient
Jansen et al.Reduces inflammatory mediators, PAMPs
Complex aortic surgery is often characterised by long periods of cardiopulmonary bypass, resulting in hyperinflammation. Providing the best conditions and setting for effective surgery and rapid patient recovery is therefore a key objective and challenge for the OR staff.
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Control bleeding risk, reduce inflammatory response
Undlien et al.Removes blood thinner, reduces impact of DAMPs and attenuates case complexity
In the case of urgent aortic surgery, patients sometimes present on anticoagulants. Avoiding exacerbations due to the need for wash-out time, intraoperative removal of these agents is an advantage of intraoperative HA. In addition, the control of inflammatory expansion by rebalancing its mediators speaks in favour of simple plug-and-play use on CPB pumps.
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Improve capillary leakage
Piskovatska et al.Removes endothelial damaging proteins
A major problem in systemic inflammatory diseases is the “leaky bucket” phenomenon at the tissue level: the endothelial firewall is disrupted, resulting in fluid loss into the interstitium and subsequent tissue edema. Circulating cytokines and certain proteins drive this process by damaging endothelial tight junctions.
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Stabilize micro and macro-circulation/SIRS
Saller et al.Supports Hemodynamic stabilization > allows vasopressor reduction
Based on the problem of capillary leakage, micro- and later macrocirculatory problems arise, leading to impaired tissue perfusion and oxygenation, as well as extensive need for supportive vasopressor medications. Mastering these crises of micro- and macrocirculatory stability is essential for patient recovery.
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Avoid SoC side and post-op effects
Mehta et al.Keeps immune response in balance
Reduced post-operative need for vasopressors, fluid support and blood products could be achieved by balancing levels of inflammatory mediators and removing various blood thinners, resulting in improved clinical recovery.
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Preserve and restore organ function
Doukas et al.Less ARDS, improved lung function. Reduced ICU stay, cost savings.
The improved intra- and post-operative condition supports faster recovery from the stressful surgery, enhances the effects of concomitant SoC treatments, and allows for shorter ICU stays with corresponding cost benefits.
Support stabilization in heart failure patients
Heart failure patients are at increased risk for cardiogenic shock and vasoplegia.
CytoSorb® Therapy is designed to adsorb elevated cytokine levels, supporting hemodynamic stabilization in critically ill patients as part of a multimodal approach.
CytoSorb Therapy can help to:
Promote hemodynamic stability
Reduce the need for postoperative dialysis (heart transplantation)
Reduce the need for postoperative dialysis (heart transplantation)
Vasoactive inotropic score during 24h after heart transplantationMajor components of vasoactive inotropic score during the first 24 h after orthotopic heart transplantation. Noradrenaline (A); Argipressin (B); Dobutamine (C); Milrinone (D). N=55. Data are presented as medians and 95% confidence intervals.
E. Nemeth et al., ESC Heart Failure 2024;11(2):772–782
Reduce vasopressor needs
Managing postoperative hyperinflammation
In postoperative settings, CytoSorb® Therapy is designed to support the management of systemic hyperinflammation and help stabilize hemodynamics.
Stabilize hemodynamics
An uncontrolled inflammatory response after surgery plays a significant role in post-op morbidity or mortality, contributing to vasoplegic shock and multi-organ dysfunction.
CytoSorb has been shown to effectively and safely reduce elevated levels of cytokines to help control postsurgical hyperinflammation and improve hemodynamic stability.
The use of CytoSorb Therapy can help safely manage the risks associated with hyperinflammation, resulting in:
Attenuation of hyperinflammation
Promotion of hemodynamic stability and shock reversal
Noradrenalin and adrenalin requirement
Promotion of hemodynamic stability and shock reversal
Boss K et al., PLoS One 2021; 16(2):e0246299
Improvement of micro- and macro-circulation
Reduction in vasopressors
Noradrenalin and adrenalin requirement
Promotion of hemodynamic stability and shock reversal
Boss K et al., PLoS One 2021; 16(2):e0246299
Best practice therapy management
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Therapy Goal
To stabilize hemodynamics and reduce mortality risk
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Patient selection
- Refractory septic/vasoplegic shock
- High (and increasing) need for vasopressors
- No (proper) response to standard of care
- Biomarkers (if available): IL-6 > 500 pg/mL, PCT > 3 µg/L, ferritin > 1000 µg/L
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Timing
- < 24 hours after diagnosis / start of standard therapy
- Do not wait until lactate is > 6.5 / 7 mmol/L
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Dosing
- Continue until sufficient hemodynamic stabilization is achieved
- Change after 12 hours if instability persists
Supporting ECMO patient management
Patients receiving ECMO are at high risk of concomitant hyperinflammation. CytoSorb® is intended to adsorb elevated cytokines and other inflammatory mediators that may accompany ECMO therapy, helping to modulate systemic inflammatory responses.
ECMO with CytoSorb
ECMO is increasingly used in ARDS and cardiogenic shock, but morbidity and mortality rates remain high.
Treatment options to enhance the clinical benefits of ECMO support and prevent complications, such as ongoing hyperinflammation, are currently limited.
CytoSorb is intended to modulate an accompanying or triggered immune response by removal of elevated levels of cytokines and thus aims to increase the chances of recovery.
Supporting VA-ECMO management
VA-ECMO supports macro-circulatory hemodynamics, but may introduce circulatory stress. Published clinical experience has described associations with accelerated stabilization of hemodynamics when CytoSorb® is used as part of ECMO management.
Supporting VV-ECMO management
- Akil et al., Thorac Cardiovasc Surg 2021; 69(3):246-251
- Akil et al., J Clin Med 2022; 11(20):5990
- Angheloiu et al., JACC Basic Transl Sci 2017; 2(2):135-145
- Bernardi et al., Crit Care 2016; 20(1):96
- Boss et al., PLoS One 2021; 16(2):e0246299
- Bottari et al., Int J Art Organs 2020; 43(9):587-593
- Calabrò et al., Artif Organs 2019; 43(2):189-194
- Cao et al., Eur Heart J 2023; 44(20):1780-1794
- Cohen et al., Am J Cardiovasc Drugs 2023; 23(4):429-440
- David et al., J Intensive Care 2017; 5(1):12
- Diab et al., 2022; 145(13):959-968
- Doukas et al., J Clin Med 2023; 12(2):546
- Gleason et al., Sem Thorac Cardiovasc Surg 2019; 31(4):783-793
- Gruda et al., PLoS One 2018; 13(1):e0191676
- Guiterrez et al., Cir Cardiov 2024; 31:56-63
- Jansen et al., Crit Care 2023; 27:117
- Javanbakht et al., PharmacoEconomics Open 2020; 4:307-319
- Haidari et al., Ann Thorac Surg 2020; 110(3):890-896
- Haidari et al., PLoS One 2022;17(7):e0266820
- Haidari et al., ICV&TS 2023; 36(1):ivad010
- Haidari et al., Ann Thorac Surg 2023; 11:3068
- Hassan et al., JTCVS Open 2023;15:190-196
- Hassan et al., Annals of Thoracic Surg 2019; 108(1):45-51
- Hassan et al., Ann Thorac Cardiovasc Surg 2022;28(3):186-192
- Hayanga et al., Int Care Med Exp 2022; 10(40):494
- Holmen et al., J Cardiothorac & Vasc Anesth 2022; 36(8 Pt B):3015-3020
- Koertge et al., Blood Purif 2018; 45(1-3):126-128
- Kalisnik et al., J Clin Med. 2022;11(14):3954
- Kuehne et al., Int J Artif Organs 2019;42(4):194-200
- Mehta et al., Interdiscip Cardiovasc Thorac Surg 2024; 38(4):ivae050
- Mehta et al., Cardiothorac Vasc Anesth 2021; 35(2):673-675
- Naruka et al., Heart Lung Circ 2022; 31(11):1493-1503
- Nemeth et al., J Clin Trans 2018; 32(4):e13211
- Nemeth et al., ESC Heart Fail 2024;11(2):772-782
- NICE Medtech innovation briefing, February 2021; www.nice.org.uk/guidance/mib249
- Piskovatska et al., Healthcare 2023; 11(3):310
- Poli et al., Crit Care 2019; 23:108
- Rao et al., J Cardiovasc Dev Dis 2023; 10(9):366
- Røed-Undlien et al., Int J Surg 2024; 110(12):7782-7790
- Rugg et al., Biomedicines 2020; 8(12):539
- Saller et al., Eur J Cardiothorac Surg 2019; 56(4):731-737
- Schmoeckel et al., J Thromb Thrombolysis 2024; epub (doi; 10.1007/s11239-024-02996-x)
- Singh et al., Am J Case Rep 2023; 24:e940383
- Soltesz et al., J Clin Med 2022; 11(21):6517
- Thielmann et al., Indian J Thorac Cardiovasc Surg 2024; 40(Suppl 1):69-77
- Traeger et al., Int J Artif Organs 2020; 43(6):422-429
- Traeger et al., Int J Artif Organs 2017; 40(5):240-249
Voices around the world
Access Healthcare Professionals Area
This area is for Health Care Professionals only and provides reports about clinical experiences gained during the use of CytoSorbents products. The information presented reflects the opinions and procedural techniques of individual physicians and is not intended as medical advice. Physician experience, risks, patient outcomes and results may vary. This content is intended for Health Care Professionals outside the United States and Canada as CytoSorb has not yet been approved or cleared in the United States or Canada for any indication, except under an Emergency Use Authorization (EUA) by the US FDA.