MONMOUTH JUNCTION, N.J., March 2, 2020 /PRNewswire/ — CytoSorbents Corporation (NASDAQ:CTSO), a critical care immunotherapy leader commercializing its blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, highlights the recent publication entitled, “Intraoperative hemoadsorption in patients with native mitral valve endocarditis,” in the journal, The Annals of Thoracic Surgery.
In this retrospective study, Dr. Zaki Haidari, MD and colleagues at the West-German Heart and Vascular Center of the University Hospital Essen, Germany investigated whether intraoperative CytoSorb® hemoadsorption could improve surgical outcomes in patients with infective endocarditis (i.e. infection of the heart valve) undergoing surgical replacement or repair of their diseased mitral heart valve. The authors retrospectively identified 58 consecutive patients, 30 of which were treated with CytoSorb therapy (CytoSorb group) and 28 that were not (control group), that underwent surgery from January 2014 to July 2017. There were no statistically significant differences between the two groups in terms of baseline demographics, hemodynamic or pulmonary instability, and levels of preoperative inflammatory parameters. The post-operative need of vasopressors to support blood pressure, as well as the incidence of post-operative sepsis, sepsis-associated death, and 30-day mortality, were compared.
Key study findings in those receiving intraoperative CytoSorb hemoadsorption included:
- Improved postoperative hemodynamic stability at ICU-admission. Postoperatively, at ICU admission, the overall need for epinephrine and norepinephrine was 0.15 versus 0.24 μg/kg BW/min (p=0.01) and the median systemic vascular resistance was 1,413 versus 1,010 dyn·s·cm-5 (p=0.02) in the CytoSorb versus control group, respectively.
- Postoperative sepsis was less frequent. As defined by the Third International Consensus Definition of Sepsis, postoperative sepsis occurred in 16.7% (5/30) in the CytoSorb group versus 39.3% (11/28) of control patients (p=0.05).
- Significant reduction in sepsis-associated deaths. No sepsis-associated deaths (0/30) occurred in the CytoSorb group, while 17.9% (5/28) of patients died from refractory septic shock in the control group (p=0.02).
- Trend to improved 30-day mortality. 30-day-mortality was 10% in the CytoSorb group versus 18% in the control group, although this did not reach statistical significance (p=0.39).
The authors also highlight the ease of use and lack of adverse events with the therapy in their patients.
Dr. Peter Nelson, MD, Senior Director of Clinical Affairs at CytoSorbents commented, “This retrospective study adds to a growing number of studies that have reported positive postoperative outcomes using CytoSorb during cardiac surgery for infective endocarditis. This is particularly exciting because these patients suffer from a very serious infection that has traditionally been associated with extremely high morbidity and mortality. We look forward to the results of current and future studies to confirm these compelling clinical observations.”
Dr. Joerg Scheier, MD, Senior Medical Director at CytoSorbents Europe stated, “These new data, strengthened by a comparable control group, further support that CytoSorb can make an important difference in the outcomes of this high risk cardiac surgery population that is particularly prone to severe complications and high mortality. It is also very reassuring to see that safety and ease of use of CytoSorb therapy could be confirmed in this very critically-ill patient group. We look forward to the results of the 250 patient, prospective, randomized, controlled REMOVE endocarditis trial that has completed enrollment and is expected to report results in the middle of this year.”
Infective endocarditis, or infection of a heart valve, is a serious condition in which patients can rapidly develop life-threatening complications such as septic shock, destruction of the heart valve, dangerous heart rhythms, heart failure, and stroke. As many as 50% of cases require open heart surgery to replace or repair the heart valve and remove infected tissue. However, patients undergoing surgery are at high risk of serious adverse events caused by their underlying disease and severe inflammation, including significant organ dysfunction and failure, refractory shock, and death. Approximately 15-20% of patients will die in the hospital while 40% will die within a year. CytoSorb is being used on many patients undergoing open heart surgery for endocarditis, due to its ability to reduce high levels of circulating inflammatory cytokines that are generated by both the infection and surgery itself. Worldwide, the number of infective endocarditis surgery cases has markedly increased with the ageing population and other reasons such as the U.S. opioid epidemic, creating a significant and growing unmet medical need from the morbidities and the high risk of death faced by these surgical patients.
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 58 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® has been used in more than 80,000 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 approximately $29 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 many issued U.S. and international 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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