MONMOUTH JUNCTION, N.J., Oct. 4, 2019 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in hemoadsorption therapies to treat life-threatening conditions, announced that Dr. Eric Mortensen, MD, PhD, Chief Medical Officer of CytoSorbents, will present data from a new study on the cost effectiveness of CytoSorb when used intraoperatively to remove ticagrelor in patients undergoing emergency open heart surgery. The presentation will occur at the 33rd Annual Meeting of the European Association for Cardio-Thoracic Surgery (EACTS) in Lisbon, Portugal on Saturday, October 5, 2019.
CytoSorb® efficiently and rapidly removes ticagrelor from whole blood, and its usage during emergency cardiac surgery with cardiopulmonary bypass was shown to reduce perioperative bleeding complications in a published observational study by physicians at the Asklepios Klinik St. Georg in Hamburg, Germany. Based on this cornerstone publication, a decision analytic cost-consequences model was applied to estimate health care resource utilization in patients on ticagrelor undergoing emergent cardiac surgery in the United Kingdom. The use of CytoSorb in this patient population significantly reduced morbidities from bleeding, including, on average, fewer blood product transfusions (-0.47 units of red blood cells and -1.16 units of platelets), fewer re-operations (36% in the control versus 0% with CytoSorb, respectively), shorter operation time (-65 minutes), shorter ICU stay (-1 day), and hospital length of stay (-3 days). As a result, CytoSorb reduced overall health care resource utilization in this model by an average of £3,982 per patient (approximately $5,000 USD per patient), including the cost of the CytoSorb adsorber, and resulted in a better health-related quality of life.
Dr. Mortensen explains, "Ticagrelor is a potent platelet inhibitor and antithrombotic therapy that is generally recognized as the standard of care to reduce the risk of heart attacks and strokes in patients with advanced cardiovascular disease. Unfortunately, because of their underlying condition, approximately 4% of patients will suffer an acute, life-threatening cardiac event while on ticagrelor that necessitates immediate cardiothoracic surgery. Unfortunately, there are no approved treatments to reverse the antithrombotic effect of ticagrelor and patients do not have the luxury of time to wait the days needed to eliminate the drug from the body. Because of this, approximately 25-30% of patients on ticagrelor who undergo emergency cardiac surgery will suffer severe or massive perioperative bleeding that not only increases the risk of poor outcomes and death, but also results in major costs to the hospital and healthcare system. These include, for example, the need for transfusion of blood products and recombinant coagulation factors, costly rethoracotomies (reopening the chest cavity to search for a source of bleeding), as well as prolonged intensive care unit and hospital stays."
Professor Ulrich Stock, MD, FRCS, Consultant Cardiothoracic and Transplant Surgeon, Harefield Hospital, Royal Brompton and Harefield NHS Foundation Trust, United Kingdom, commented, "Severe post-operative bleeding is a dreaded complication for every cardiac surgeon, but in patients on ticagrelor or other antithrombotic agents who require emergency surgery, there is often little choice than to take that risk. The Hamburg study using CytoSorb is potentially game changing, giving surgeons the opportunity to normalize that bleeding risk. This may then allow the immediate treatment of not just emergent cases, but urgent cases as well rather than making them wait in the hospital at high expense until their bleeding risk lessens. I expect this would significantly increase the already attractive cost savings seen in this study in emergent patients alone. CytoSorb has the potential to convert a surgeon's nightmare into routine cardiac surgery."
Dr. Brad Taylor, MD, MPH, Professor of Cardiothoracic Surgery at the University of Maryland, United States, stated, "This study highlights for the first time the significant health care resource burden faced by cardiothoracic surgery practices, whether based in the U.K. or elsewhere, in the emergent surgical care of patients on ticagrelor, and how an intervention such as CytoSorb addresses this burden and improves surgical outcomes for patients."
Dr. Mortensen concluded, "Real world data indicate a strong clinical and economic benefit of using CytoSorb in this population. We look forward to rapidly advancing CytoSorb from an investigational therapy for ticagrelor removal to a cost effective standard of care in these patients."
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® is also being used during and after cardiac surgery to reduce inflammatory mediators that can lead to post-operative complications, including multiple organ failure. CytoSorbents is conducting its pivotal REFRESH 2-AKI 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 67,000 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 $26 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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