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CytoSorb® is CE-mark approved in the E.U. in the U.S., CytoSorb® and DrugSorb-ATR® are investigational devices not yet FDA authorized/approved/cleared.
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Cardiovascular

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 carry an increased risk of perioperative bleeding.

  • Intraoperative Use of CytoSorb®

    Intraoperative integration of CytoSorb on the cardiopulmonary bypass circuit (CPB) is approved for the removal of the antithrombotic agents ticagrelor and rivaroxaban and may also by employed for the removal of cytokines to manage the enhanced inflammatory response that frequently complicates complex cardiac surgeries.

    The therapy is designed to adsorb elevated cytokines, 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. Use of CytoSorb in complex cardiac surgery is part of a mlutimodal treatment plan intended to support hemodynamic stability in these high-risk patients.

    Clinical studies show that the presence of hyperinflammation in patients undergoing complex operations such as aortic surgery, heart transplantation or infective endocarditis surgery may complicate the perioperative course primarily due to hemodynamic instability. Cytokine removal with CytoSorb in these settings may potentially contribute to hemodynamic stabilization.

  • Postoperative Use of CytoSorb®

    Hyperinflammation and hemodynamic instability may persist in the postoperative setting and cytokine removal with CytoSorb in addition to standard measures for circulatory support may contribute to the achievement of hemodynamic stabilization.

    (Boss K et al., PLoS One 2021; 16(9):e024629.)

Use of Cytosorb® for Cytokine - or Antithrombotic - removal may be considered in various cardiovascular indications

Antithrombotics Infective endocarditis Aortic surgery Heart failure Postoperative hyperinflammation ECMO

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

Patients on antithrombotic drugs who require urgent or emergent cardiac surgery and cannot wait for drug washout face a high risk for serious perioperative bleeding complications.

CytoSorb is approved for use during CPB in patients on ticagrelor or rivaroxaban undergoing urgent or emergent cardiac surgery with the goal of reducing the severity of perioperative bleeding.

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Best practice therapy management

  • Therapeutic goal

    Reduction of bleeding complications, blood product use, and length of ICU stay

  • 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.

  • Timing

    Start therapy with the start of CPB. CytoSorb® is easily integrated into the CPB circuit (post-pump to venous reservoir)

  • 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 with CytoSorb use in infective-endocarditis surgery:

Promotion of hemodynamic stability
Reduction in vasopressors needs
Reduction in vasopressors needs
Haidari Z et al., Ann Thorac Surg 2020; 110(3):890-896
Reduction in sepsis and sepsis-related mortality
Reduction in sepsis and sepsis-related mortality
Kalisnik JM et al., J Clin Med. 2022;11(14):3954
Reduction in mortality in patients infected with Staphylococcus aureus
Reduction in mortality in staph aureus patients
Haidari et al., ICV&TS 2023; 36(1):ivad010

Infective Endocarditis

General Treatment Goals

CytoSorb is intended to lower excessive levels of cytokines in the patients blood. This therapeutic measure can support management of local and systemic inflammatory processes in patients with infective endocarditis.

  • Patient Selection
    Timing
    Dosing

    Highly Recommended
    • Heart surgery under “hot” endocarditis (fever, hemodynamic instability, critical status)
    • Elevated inflammatory markers indicating systemic hyperinflammation
    • Staphylococcus aureus infection (MSSA & MRSA)
    • Usually: Start directly with CPB
    • If needed: Start any time during CPB
    • Usually: 1x adsorber during entire CPB run
    • If needed: 1x new adsorber during postoperative phase in case of hemodynamic instability or rebound on ICU
    • Adsorber changes after 12-24 hrs. until sufficient hemodynamical stabilization (catecholamine free)

    Recommended
    • Increased vasopressors need during IE surgery
    • EuroSCORE-II >8%
    • High-grade intraoperative findings (vegetations, root abscess)
    • Any prosthetic valve endocarditis (redo) including post TAVR
    • Elevated inflammatory markers indicating systemic hyperinflammation
    • Pre-existing kidney and/or liver dysfunction

    Highly Recommended

    • Heart surgery under “hot” endocarditis (fever, hemodynamic instability, critical status)
    • Elevated inflammatory markers indicating systemic hyperinflammation
    • Staphylococcus aureus infection (MSSA & MRSA)
    • Usually: Start directly with CPB
    • If needed: Start any time during CPB
    • Usually: 1x adsorber during entire CPB run
    • If needed: 1x new adsorber during postoperative phase in case of hemodynamic instability or rebound on ICU
    • Adsorber changes after 12-24 hrs. until sufficient hemodynamical stabilization (catecholamine free)

    Recommended

    • Increased vasopressors need during IE surgery
    • EuroSCORE-II >8%
    • High-grade intraoperative findings (vegetations, root abscess)
    • Any prosthetic valve endocarditis (redo) including post TAVR
    • Elevated inflammatory markers indicating systemic hyperinflammation
    • Pre-existing kidney and/or liver dysfunction

  • Therapy Goals

    • Controlling systemic inflammation
    • Stabilization of micro- and macro-hemodynamics (catecholamine free)

  • Principles

    • Start immediately to gain early anti-inflammation effect

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 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
Perioperative vasopressor therapy
Saller T et al., Eur J Cardiothorac Surg 2019; 56(4):731-737
Reduce blood product use
Reduce blood product use
Saller T et al., Eur J Cardiothorac Surg 2019; 56(4):731-737
Reduce vasopressor needs
Perioperative vasopressor therapy
Saller T et al., Eur J Cardiothorac Surg 2019; 56(4):731-737

Aortic surgery

General Treatment Goals

CytoSorb is intended to lower excessive cytokine levels and blood thinning agents such as Ticagrelor or Rivaroxaban in patients undergoing on-pump cardiac surgery. These therapeutic measures can support reduction of bleeding risks and management of local as well as systemic inflammatory processes.

  		•
    Patient Selection
    Timing
    Dosing

    Highly Recommended
      Complex aortic surgery (e.g. aortic dissection, aortic root surgery planned)

    • High lactate preoperatively
    • Deep hypothermic circulatory arrest planned
    • Cerebral perfusion planned
    • Hemodynamic instability req. high vasopressor support
    • Thoracoabominal aortic repair planned
    • Usually: Start directly with CPB
    • If needed: Start any time during CPB
    • Usually: 1x adsorber during entire CPB run
    • If needed: 1x new adsorber during postoperative phase in case of hemodynamic instability or rebound on ICU
    • Adsorber change after 12-24 hrs. until
      sufficient hemodynamical stabilization (catecholamine free)

    Recommended
      • Pre-existing kidney and/or liver dysfunction

     

      During routine/aortic surgery in case of:

    • Development of intraoperative oliguric renal failure
    • Increased vasopressors
    • Significant unexpected findings
    • Suspected visceral ischemia

    Highly Recommended

      Complex aortic surgery (e.g. aortic dissection, aortic root surgery planned)

    • High lactate preoperatively
    • Deep hypothermic circulatory arrest planned
    • Cerebral perfusion planned
    • Hemodynamic instability req. high vasopressor support
    • Thoracoabominal aortic repair planned
    • Usually: Start directly with CPB
    • If needed: Start any time during CPB
    • Usually: 1x adsorber during entire CPB run
    • If needed: 1x new adsorber during postoperative phase in case of hemodynamic instability or rebound on ICU
    • Adsorber change after 12-24 hrs. until
      sufficient hemodynamical stabilization (catecholamine free)

    Recommended

      • Pre-existing kidney and/or liver dysfunction

     

      During routine/aortic surgery in case of:

    • Development of intraoperative oliguric renal failure
    • Increased vasopressors
    • Significant unexpected findings
    • Suspected visceral ischemia

  • Therapy Goals

    • Controlling systemic inflammation
    • Stabilization of micro- and macro-hemodynamics (catecholamine free)

  • Principles

    • Start immediately to gain early anti-inflammation effect and effective bleeding control in case of preoperative anticoagulant treatment

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 transplantation

Major 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 to remove cytokines is designed to support the management of systemic hyperinflammation and help stabilize hemodynamics.

Support 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 is indicated for the removal of cytokines which may in turn contribute to the management of hyperinflammation and to hemodynamic stabilization.

The use of CytoSorb Therapy can help 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

  • Therapy Goal

    To stabilize hemodynamics and reduce mortality risk

  • 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
  • Timing
    • < 24 hours after diagnosis / start of standard therapy
    • Do not wait until lactate is > 6.5 / 7 mmol/L
  • Dosing
    • Continue until sufficient hemodynamic stabilization is achieved
    • Change after 12 hours if instability persists

Supporting ECMO patient management

Patients on ECMO frequently exhibit signs and symptoms of hyperinflammation. CytoSorb® intended to remove elevated cytokines may help modulate the systemic inflammatory response.

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.

 

Hyperinflammation is frequently present during ECMO support and CytoSorb with its approved use for removal of elevated cytokines may contribute to the overall efforts to control the systemic inflammatory response.

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.

Sequential Organ Failure Assessment (SOFA) Score

Soltesz et al., J Clin Med 2022; 11(21):6517

Vasoactive Inotropic (VIS) Score

Soltesz et al., J Clin Med 2022; 11(21):6517

Supporting VV-ECMO management

VV-ECMO in Critical Care

Additional Information

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Recommended literature
Recommended literature
Flowchart Recommended literature
Recommended literature
Flowchart Evolution of evidence Recommended literature
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  • Haidari et al., ICV&TS 2023; 36(1):ivad010
  • Haidari et al., Ann Thorac Surg 2023; 11:3068
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CytoSorb 300 IFU 03/2023 – Indications:
CytoSorb is indicated for use in conditions where elevated levels of cytokines and/or bilirubin and/or myoglobin exist. CytoSorb is indicated for use intraoperatively during cardio-pulmonary bypass surgery for the removal of P2Y12-Inhibitor Ticagrelor and/or Factor Xa-Inhibitor Rivaroxaban. Results from current studies suggest that CytoSorb may be administered for up to 7 consecutive days. Maximum Treatment Time per Device: 24 Hour.

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.