Role of Cytosorb in Left Ventricular Assist Device Implantation

Summary

Mechanical circulatory support, specifically implantable continuous flow left ventricular assist device (CF-LVAD) therapy has been established as a viable treatment for rapidly deteriorating patients suffering from end stage heart failure either as bridge or alternative to heart transplantation. However, a large proportion of these patients experience severe complications in the early postoperative period including right ventricular failure or multi organ failure leading to increased mortality. The leading theory explaining these complications involves exaggerated systemic inflammatory response prior to, during and early after CF-LVAD insertion. Among the cytokines IL-6 appears to play a major role. There is increasing demonstration of the efficacy of a cytokine haemoadsorption (HA) technology in attenuating cytokine response and particularly IL-6 in various inflammatory states and emerging data on the safety of the Cytosorb® device in routine and complex cardiac surgery. The study team hypothesizes that Cytosorb® treatment is feasible and safe in heart failure patients undergoing LVAD insertion and that it is effective in attenuating IL-6 secretion with benefit in the wider inflammatory and metabolic response to this high-risk surgery.

Eligibility

Inclusion Criteria:

Adult patients (≥18 years), but ≤70 years; Scheduled for elective LVAD implantation with the use of cardiopulmonary bypass; Written informed consent for participation

Exclusion Criteria:

* Poor spoken and/or written language comprehension
* Declined or missing informed consent
* LVAD implant planned without use of CPB
* Total Artificial Heart implantation
* Planned CPB temperature \< 32 °C
* AIDS with a CD4 count of \< 200/μL
* Severe thrombocytopenia (PLT \<50000
* Application of contrast medium on the day of surgery
* Immunosuppressive therapy or long-term therapy with corticosteroids
* Contraindication to anticoagulation with heparin
* Participation in another clinical intervention trial

Conditions2

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