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Cardiovascular

Protect your cardiovascular patients

Complex cardiac surgeries with use of CPB can result in a dysregulated immune response with clinical complications like vasoplegic shock and multi-organ dysfunction syndrome. Emergency cardiac surgeries in patients on antithrombotic drugs such as ticagrelor or rivaroxaban can result in severe bleeding complications.

  • Intraoperative

    The use of CytoSorb® during surgery is intended to prevent postoperative hyperinflammation and its complications, or to remove ticagrelor and rivaroxaban in order to reduce the bleeding risk.

    Re-balancing the immune response and reducing or preventing the related damage is prudent in very complex procedures, such as heart transplantation or aortic surgery, or in cases of infective endocarditis surgery, when the immune system is already activated and there is a high risk for further activation during surgical intervention. Intraoperative use of CytoSorb is then meant to help improve hemodynamic stability and postoperative outcomes.

  • Postoperative

    In the postoperative setting, our innovative CytoSorb technology works quickly to support shock reversal – a vital, life-saving measure needed to avoid the devastating effects of ongoing systemic hyperinflammation causing severe hemodynamic instability, eventually resulting in multi-organ failure.

    Boss K et al., PLoS One 2021; 16(2):e0246299

Safeguard urgent surgeries against bleeding risks

Interoperative use of CytoSorb swiftly removes antithrombotic agents, reducing bleeding complications in urgent surgeries and enhancing patient safety.

Master bleeding risks

In case of urgent or emergency surgery with no time to wait, antithrombotics can lead to an increase in perioperative bleeding. CytoSorb has been shown to be safe and effective for intraoperative antithrombotic drug removal.

 

When it comes to cardiac surgery, the underlying pathology, the complexity of the surgical procedures, and the urgent or emergent need for surgery mean there is an inherently higher risk of perioperative bleeding. The use of DOACs like e.g. rivaroxaban and the anti-platelet agent ticagrelor pose an even higher additional risk of bleeding if drug washout is not possible.

By removal of ticagrelor and rivaroxaban during cardiopulmonary bypass surgery, CytoSorb has been shown to support faster patient recovery by reducting perioperative bleeding:

Reduced operation time
Reduced RBC transfusion
Reduced PLT transfusion
Reduced re-thoracotomy rates
Reduced ICU length of stay
Reduced drainage volume

Cost effectiveness

CytoSorb Therapy provides significant cost savings over standard of care across several healthcare systems (1-2)

Healthcare system
Overall cost saving vs Standard of care £3,941 (1) €4,200 ± 1,100 (2)
Overall cost saving vs Standard of care
£3,941 (1)
€4,200 ± 1,100 (2)
    1. Javanbakht et al., Pharmacoecon Open 2020; 4(2):307-319
    2. Hassan et al., Presented at ESC Congress, Barcelona Spain, August 2022: 1279

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.

Protect your surgical outcomes

Major surgery with CPB poses the risk of postoperative complications related to hyperinflammation. Intraoperative use of CytoSorb is intended to remove excessive levels of cytokines, thereby preventing these complications.

Stabilize your infective-endocarditis patients

 

Despite being a curative therapeutic approach, infective-endocarditis surgery carries the risk of bacterial spread and further activation of the immune system, resulting in severe hemodynamic instability and further complications like multi-organ failure.
CytoSorb has been shown to effectively and safely reduce elevated levels of cytokines in infective-endocarditis patients.

By removal of elevated cytokines, CytoSorb Therapy can help to safely manage infective endocarditis patients through reduction in perioperative bleeding:

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.

  • Reduce endothelial damaging proteins / toxins and hemolysins

    Removes excessive cytokines and inflammatory mediators/DAMPs etc

    In cases of “hot” endocarditis, when patients show full blown inflammation signs, fever and positive blood cultures, cardiac surgery faces the challenge of intra-and postoperative hemodynamic instability. Based on the systemic inflammation status and peri-operative burden, mortality in these high-risk patients is high.
     

    Kalisnik et al.
  • Improve capillary leakage / Reduce pathogenicity (e.g. S. aureus)

    Removes endothelial damaging proteins / toxins and hemolysins

    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.
     

    Piskovatska et al.
  • Stabilize micro- and macro-circulation

    Supports Hemodynamic stabilization > 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 microcirculatory stability is essential for patient recovery.
     

    Holmen et al.
  • Avoid SoC side and post-op effects

    Keeps immune response in balance

    With a balanced level of cytokines and DAMPS/PAMPS, less postoperative need for vasopressors and fluid support could be achieved, resulting in improved mortality outcomes.
     

    Haidari et al.
  • Preserve and restore organ function

    Reduces sepsis / infection-associated mortality > faster recovery > shorter 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.
     

    Rao et al.
  • 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

Protect aortic surgery patients

 

Complex cardiac surgeries like aortic surgery can result in a dysregulated immune response with clinical complications such as vasoplegic shock or multi-organ failure.

 

CytoSorb has been shown to reduce elevated levels of cytokines to promote hemodynamic stability and protect aortic surgery patients from hyperinflammation risk.

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.

  • Protect your Aortic Surgery patient

    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.
     

    Jansen et al.
  • Control bleeding risk, reduce inflammatory response

    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.
     

    Undlien et al.
  • Improve capillary leakage

    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.
     

    Piskovatska et al.
  • Stabilize micro and macro-circulation/SIRS

    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.
     

    Saller et al.
  • Avoid SoC side and post-op effects

    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.
     

    Mehta et al.
  • Preserve and restore organ function

    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.
     

    Doukas et al.
  • 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

Stabilize your heart failure patients

Heart failure patients carry a high risk of developing cardiogenic shock, which, like other states of hypoperfusion, can trigger the immune system and result in a dysregulated immune response with vasoplegic shock and further severe clinical consequences. Patients undergoing orthotopic heart transplantation are among the highest risk for perioperative vasoplegic syndrome.

 

CytoSorb has been shown to reduce elevated levels of cytokines to help stabilize heart failure patients.

CytoSorb Therapy can help to:

Promote hemodynamic stability
Reduce the need for postoperative dialysis (heart transplantation)
Reduce vasopressor needs

Control postsurgical hyperinflammation

In a postoperative setting, our innovative CytoSorb technology works quickly to support shock reversal – a vital, life-saving measure needed to avoid the devastating effects of ongoing systemic hyperinflammation causing severe hemodynamic instability, eventually resulting in multi-organ failure.

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
Improvement of micro- and macro-circulation
Reduction in vasopressors

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

Support your ECMO patients

ECMO patients have a high risk of concomitant hyperinflammation. Either the underlying disease leading to the need for ECMO is associated with hyperinflammation, or the extracorporeal circuit can trigger it.

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.

Enhance VA-ECMO Outcomes

Venoarterial (VA) ECMO supports the normalization of macro-circulatory hemodynamics and fluid balance, but mechanical circulatory support itself can introduce stress, which negatively impacts on micro-circulatory function. CytoSorb accelerates the stabilization of hemodynamics in VA-ECMO patients, promoting organ recovery.

Sequential Organ Failure Assessment (SOFA) Score
Vasoactive Inotropic (VIS) Score

Support VV-ECMO patients

Additional Information

  • 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
CytoSorbents

Voices around the world

world map
Cardiovascular
Prof. Dr. Markus Krane
Munich, Germany

Post-operative bleeding and related post-operative blood transfusion, that are usually necessary, are reduced. And that’s a better outcome for the patient.

Critical Care Kidney
Dr. Alessandra Lombardo
Legnano, Italy

I remember this case because it was a rhabdo like we have never seen before. And I remember CytoSorb was a very
big part of his treatment.

Critical Care
Janine Emmerich
Bad Bevensen, Germany

The patient had a really long medical course and the weaning took long as well. But after all this, he came by to visit us. It was a striking moment.

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.