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New Study Demonstrates Improved Hemodynamic Stability After Heart Transplant Surgery using Intraoperative CytoSorb® Blood Purification

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Severe vasoplegia (i.e. critically low blood pressure due to a loss of vascular resistance despite high cardiac output) is one of the most dangerous adverse events that occurs in up to 44% of patients following heart transplantation.  Often driven by inflammation and excessive cytokines, vasoplegia can result in inadequate perfusion and oxygen delivery to vital organs, resulting in increased risk of acute kidney injury (AKI), intestinal and brain ischemia, acute lung injury, and other complications that trigger morbidity and mortality. To stabilize the blood pressure, patients often need high doses of vasopressors, inotropes, and mechanical support. Unfortunately, these interventions do not address the underlying cause of vasoplegia, and can exacerbate organ injury, as is often seen with vasopressors, for example.

In this prospective, single center, observational study, a total of 84 heart transplant patients (60 control, 24 treatment using CytoSorb during surgery) between January 2015 and December 2016 were analyzed via propensity score matching, yielding a total of 16 matched pairs of control and treatment patients, with similar baseline characteristics.  Control patients received standard of care, while treatment patients received standard of care with CytoSorb installed in the heart-lung machine during the entire open heart surgery and heart transplantation procedure.  

Key findings of the study were:

The need for vasopressors, specifically noradrenaline (aka norepinephrine), was significantly lower in the CytoSorb treatment group compared to control during the first 24 hours post-transplantation (0.14 vs 0.30 ug/kg*min control, p=0.04) and the second postoperative day (0.06 vs 0.32 ug/kg*min control, p=0.05)   Even with lower usage of vasopressors in the postoperative period, the treatment group was able to achieve similar primary hemodynamic parameters, such as cardiac index, mean arterial blood pressure, and systemic vascular resistance, as seen in the control group, but also a markedly improved lactate compared to controls during the first 24 hours after surgery, suggesting improved tissue perfusion There was a trend towards less acute kidney injury, shorter mechanical ventilation times, and shorter intensive care unit (ICU) stays.  The treatment group also had fewer cases of acute or acute-on-chronic renal failure requiring renal replacement therapy (2 vs 4 cases control, p=0.03)  There were no deaths in the treatment group during the first month after transplantation, compared to two cases in the propensity-matched control group From a safety standpoint, there was no difference in postoperative blood loss and number of transfused blood products, with a trend to fewer incidences

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