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

MONMOUTH JUNCTION, N.J., Feb. 1, 2018 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, highlights the recent publication entitled, "Impact of intraoperative cytokine adsorption on outcome of patients undergoing orthotopic heart transplantation – an observational study" in the medical journal Clinical Transplantation.  In this study, Dr. Endre Németh and colleagues at the Heart and Vascular Centre of Semmelweis University in Hungary explore the potential benefit of intraoperative CytoSorb blood purification during open heart surgery and heart transplantation on common, but potentially fatal, postoperative complications. 

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 of surgical re-exploration or cardiac tamponade in the treatment group (2 vs 5 cases control, p=0.06)

Dr. Phillip Chan, CEO of CytoSorbents stated, "It is fascinating that CytoSorb treatment during surgery has an apparent lasting benefit in reducing vasoplegia through postoperative Day 2.  These data are consistent with the observed ability of CytoSorb to improve blood pressure and restore hemodynamic stability in a wide range of conditions including septic shock, refractory shock, trauma, liver failure, complications of surgery, and many others.  Meanwhile, this study adds to the expanding body of clinical evidence supporting the potential future standard of care use of CytoSorb in open heart surgery and solid organ transplantation."

According to the Organ Procurement and Transplantation Network (OPTN), there were more than 3,200 heart transplants in the United States in 2017, up approximately 50% in the past decade, and more than 5,000 heart transplants worldwide each year.  Each of these patients must undergo open heart surgery with cardiopulmonary bypass.  Globally, more than 100,000 solid organ transplants are performed annually.  CytoSorbents' previously announced collaboration with Aferetica and its PerLife™ ex vivo organ rehabilitation system has the potential to significantly expand this market by improving high quality solid organ availability.

About CytoSorbents Corporation (NASDAQ: CTSO)

CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb® is approved in the European Union with distribution in 44 countries around the world, as an extracorporeal cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" that could otherwise cause massive inflammation, organ failure and death in common critical illnesses. These are conditions where the risk of death is extremely high, yet no effective treatments exist.  CytoSorb® is also being used during and after cardiac surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. CytoSorbents recently received U.S. FDA approval to initiate its pivotal REFRESH (REduction in FREe Hemoglobin) 2 trial – a multi-center, randomized controlled, clinical trial intended to support U.S. regulatory approval of CytoSorb for use in a heart-lung machine during complex cardiac surgery to reduce organ injury.  CytoSorb® has been used in more than 35,000 human treatments to date.

CytoSorbents' purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of nearly $22 million from DARPA, the U.S. Army, the U.S. Department of Health and Human Services, the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), U.S. Special Operations Command (SOCOM) and others. The Company has numerous products under development based upon this unique blood purification technology, protected by 32 issued U.S. patents and multiple applications pending, including CytoSorb-XL™, HemoDefend™, VetResQ™, K⁺ontrol™, ContrastSorb, DrugSorb, and others.  For more information, please visit the Company's websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.

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SOURCE CytoSorbents Corporation

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