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Update on CytoSorb® therapy in liver dysfunction | Webinar Liver | 2022
bt48, did you happen to follow up on ATNM that I told you about?
When both issues were trading in the $5-6 range? Today was a $60,000 day for me which makes the pain I’ve endured here a tiny bit less painful. Maybe if they clean sweep the pitiful top management (and I use the term management loosely) CTSO can achieve a similar day of impressive gain. Time will tell. Not too late for the ATNM train!
Why is she bailing out before a replacement has been found?
Not a good sign?
lLnk to Dawson James Research recent CTSO report:
https://dawsonjames.com/wp-content/uploads/2022/10/CTSO.10.6.22-final1.pdf
NEWS -- National Institutes of Health Grants Phase I SBIR Award to CytoSorbents to Test Novel Polymers for Cytokine and Endotoxin Removal from Septic Porcine Plasma
Goal is to advance new combined blood purification technologies to treat Gram negative sepsis – a deadly global killer
PRINCETON, N.J., Oct. 31, 2022 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced today that the National Institute of General Medical Sciences (NIGMS), a division of the U.S. National Institutes of Health, has granted CytoSorbents a Phase I Small Business Innovation Research (SBIR) award valued at $281,835. The eight-month award (Award #1R43GM144973-01) will allow CytoSorbents to test the ability of its novel and existing polymers to remove cytokines and lipopolysaccharide (LPS) endotoxin from septic porcine plasma. LPS endotoxin, released by Gram-negative bacteria such as E. coli, Salmonella, Pseudomonas, Klebsiella, and Legionella, is a well-known potent and deadly trigger of sepsis and septic shock by activating the immune system and generating a cytokine storm that can lead to massive, uncontrolled systemic inflammation, organ failure, and potentially death.
Goal is to advance new combined blood purification technologies to treat Gram negative sepsis - a deadly global killer
Dr. Phillip Chan, MD, PhD, Chief Executive Officer of CytoSorbents stated, "Gram-negative infections play an important and feared role in sepsis, accounting for approximately 40% of cases of septic shock, and more than 30% of hospital-acquired infections. These patients tend to be very sick and have a high risk of death. We are the pioneer in the treatment of sepsis and septic shock by targeting cytokine storm and deadly inflammation with our European Union approved extracorporeal cytokine adsorber, CytoSorb®. But we believe the combination of extracorporeal cytokine and endotoxin removal from blood, in conjunction with antibiotics, may be an even more effective therapy for Gram-negative infections, and will help us to save more lives. We are grateful for the support from NIGMS to conduct the preliminary in vitro work needed before we evaluate our new polymers in a pig model of Gram-negative sepsis in the future."
Sepsis is the overzealous immune response to an infection and is responsible for approximately one in every five deaths worldwide each year. This has led the World Health Organization (WHO) to declare it a "global health priority." Sepsis accounts for approximately 10-20% of all intensive care unit (ICU) admissions, where patients either have sepsis when admitted to the ICU, or develop sepsis as a result of a nosocomial or hospital-acquired infection while in the ICU. Gram-negative infections commonly trigger septic shock, a serious complication of sepsis where the blood pressure drops to dangerously low levels and organ failure and death can ensue. Despite antibiotics and the best standard of care, septic shock still has a mortality of 35-50%.
The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces "cytokine storm" or "cytokine release syndrome" in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to postoperative complications, including multiple organ failure. As of June 30, 2022, more than 179,000 CytoSorb devices have been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The company has initiated two FDA-approved pivotal studies to support FDA marketing approval of DrugSorb-ATR in the United States. The first is the randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at 30 centers to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. The second study is the STAR-D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial of 120 patients at 30 centers evaluating the intraoperative use of DrugSorb-ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery and taking direct oral anticoagulants, including apixaban and rivaroxaban.
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 more than $48 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb™-ATR, ContrastSorb, and others. For more information, please visit the Company's websites at https://www.cytosorbents.com and https://www.cytosorb.com or follow us on Facebook and Twitter.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 10, 2022, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
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Company Contact:
Kathleen Bloch
(732) 398-5429
mailto://kbloch@cytosorbents.com
U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
mailto://ekim@rubensteinpr.com
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SOURCE CytoSorbents Corporation
Case of the Week
Literature Database
A New Apheresis Device for Antithrombotic Drug Removal during Off-Pump Coronary Artery Bypass Surgery
Helmut Mair 1, Norman Micka1, Ferdinand Vogt1,2, Dow Rosenzweig1, Frank Vogel3, Benedikt Baumer1 , Stephanie Ulrich4 and Peter Lamm1 | 1Department of Cardiac Surgery, Artemed Klinikum München Süd, 81379 Munich, Germany | 2Department of Cardiac Surgery, Paracelsus Medical University, 40791 Nuremberg, Germany | 3Department of Anesthesiology, Artemed Klinikum München Süd, 81379 Munich, Germany | 4Department of Cardiology, Benedictus Krankenhaus Tutzing, 82327 Tutzing, Germany | Medicina 2022; 58(10):1427
10/19/2022
New!Case of the week
Download documentDownload document
Summary
CoW 35/2022 – This case reports on an a 74-year-old male patient who was admitted to Artemed Klinikum Munich South, for urgent coronary artery bypass grafting (CABG) for severe three-vessel disease (occluded right coronary artery, severe stenosis of the left descending artery, and severe stenosis of the circumflex artery).
Case presentation
The patient was treated with Dual Antiplatelet Therapy (DAPT) (ticagrelor 2×90 mg/day plus aspirin 100 mg/day) for the acute coronary syndrome and non-ST elevated myocardial infarction (NSTEMI) after an acute occlusion of the right coronary artery
Additional medical history included hypothyroidism, moderate diverticulitis, hypercholesterolemia, and hypertension
In addition to DAPT, the patient was treated with rosuvastatin, bisoprolol and L-thyroxin
Ticagrelor was stopped the day before surgery
After the initiation of standard anesthetic care, tubes were connected to a 12 F, 3-lumen high-flow catheter, which was implanted into the right cervical vein of the patient. This enabled treatment with the CytoSorb intended to remove residual ticagrelor throughout the operation
The off-pump coronary artery bypass (OPCAB) procedure included harvesting the left internal thoracic artery (LITA), myocardial revascularization using an Octopus tissue stabilizer with the LITA to the left anterior descending artery and venous grafts to the circumflex artery and to the right coronary artery. The procedure was then finished using standard techniques while the graft showed good flow rates
Treatment
Adsorption was initiated with the skin incision and was continued for 221 min
CytoSorb was run in conjunction with a new apheresis platform, PUR-01 (Nikkisio Co., Ltd., Tokyo, Japan)
Blood flow rate: 150-200 ml/min. The blood volume that had circulated through the CytoSorb during the 221 min treatment phase was 39.04 L
Anticoagulation: with start, 5000 I.E. single injection of heparin. Prior to the bypass anastomosis, another 10,000 units of heparin were administered (activated coagulation time > 300 s)
Measurements
Hemodynamics and norepinephrine requirements
Chest drain volume
Hemoglobin
Creatine kinase levels
Results
Mid-range doses of norepinephrine could be reduced and finally stopped by the end of the first postoperative day
The chest tubes delivered 440 mL in 24 h
Hemoglobin (Hb) dropped from 13.1 g/dL preoperatively to 9.3 g/dL postoperatively so that perioperatively, 2 units of red blood cells were infused
Postoperatively, the maximum creatine kinase level was 232 U/L (normal range, < 190 U/L), and the creatine kinase MB (CKMB) isoenzyme was 6.5 µg/L (normal range, < 5.2 µg/L)
Patient Follow-up
Postop the patient was transferred to the intensive care unit and was extubated the same day
Chest tubes were removed on the second postoperative day
On discharge, the Hb was 12.4 g/dL
The further postoperative course was uneventful, with good recovery of the patient
At the 6 weeks follow-up, the patient demonstrated a normal left ventricular function and sinus rhythm, with no cardiac symptoms
Conclusion
This is the first report on the intraoperative use of a PUR-01 apheresis pump in combination with a CytoSorb adsorption column to remove ticagrelor during an OPCAB procedure
The treatment resulted in good control of the peri- and postoperative bleeding risk and hemodynamic stabilization, with a concomitant reduction in norepinephrine requirements as well as an overall satisfactory clinical outcome
This is the first publication showing that the setup is feasible and safe with no device-related adverse events occurring
Note from CytoSorbents: The setting to use CytoSorb for ticagrelor removal outside cardiopulmonary bypass, however, is not covered in the current Instructions for Use.
Thanks Andy, the device seems to be working well.
A New Apheresis Device for Antithrombotic Drug Removal during Off-Pump Coronary Artery Bypass Surgery
Mair H, Micka N, Vogt F, Rosenzweig D, Vogel F, Baumer B, Ulrich S, Lamm P. Medicina 2022; 58(10):1427
10/12/2022
New!Observational studyPeer Reviewed Published DataSafetyStandalone (HP)TransfusionsAnti throm. removalRe-thoracotomyCardiac surgeryCase seriesDrug removalIntra-Op
Link to source
Summary
In this report, the first reference case on the use of CytoSorb with the direct hemoperfusion pump PUR-01 (Nikkisio) is reported, during urgent off-pump cardiac surgery (OPCAB) in a 74 yr old on concomitant Dual Antiplatelet Therapy (DAPT) with ticagrelor and aspirin. The hemoperfusion device ran for 221 mins to eliminate ticagrelor with a total blood volume through the CytoSorb of 39.04 L. The patient’s care postoperatively was uneventful and he made a good recovery with no cardiac symptoms at six week follow up. Since this initial case a further 3 patients on DAPT requiring OPCAB surgery have been operated on using this system. In all patients the intraoperative surgical procedure has not been complicated by any remarkably enhanced bleeding, no patient has required a reoperation, and the postoperative course has been uneventful. In summary, in this study the use of CytoSorb with a hemoperfusion pump during OPCAB surgery for the removal of the antiplatelet drug ticagrelor has proved successful, with no device related adverse events occurring. Treatment has resulted in good control of the peri- and postoperative bleeding risk, hemodynamic stabilization, and satisfactory clinical outcome.
CytoSorbents Reports New Cardiac Surgery Data with CytoSorb at the European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting
October 12 2022 - 07:00AM
PR Newswire (US)
Alert
PRINCETON, N.J., Oct. 12, 2022 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced the presentation of exciting new data on the use of CytoSorb® in various cardiac surgery indications at the 36th European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting last week in Milan, Italy.
During the main scientific session, Professor Matthias Thielmann - Dept. of Thoracic and Cardiovascular Surgery, West-German Heart & Vascular Center, University Duisburg-Essen, Germany presented the "Effect of intraoperative hemoadsorption therapy in acute infective endocarditis with confirmed Staph. aureus bacteremia."
The incidence of infective endocarditis, or infection of a heart valve, is increasing globally. Staphylococcal aureus endocarditis (SAE) accounts for roughly a quarter to a third of all cases and is a dreaded complication associated with intravenous drug abuse and use of dirty needles, hospital-acquired infections, prosthetic heart valves, and community acquired endocarditis. Importantly, SAE is the most aggressive form of valvular infection and can lead to a myriad of complications including rapid destruction of the valve, heart failure, cytokine storm, florid septic shock, septic embolization, and the highest mortality risk among all types of infective endocarditis, even with surgical replacement of the heart valve. CytoSorb is used in this patient population during open heart surgery to control cytokine storm, reduce inflammation and Staphylococcal toxins, and reverse shock.
Study population: 130 consecutive patients with confirmed SAE who underwent heart valve surgery at 2 leading German Heart Centers between 01/2015 – 03/2022. Mean age (60.8 vs. 60.7, p=ns) and baseline risk according to EuroScore II (12.0 vs. 11.9, p=ns) were nearly identical in the two groups. Approximately 25% of patients had a repeat cardiac operation while almost 20% were IV drug users.
Study objectives: To compare clinical outcomes between patients who underwent standard of care valve replacement surgery (Control group; n=55) and patients who underwent standard of care valve replacement surgery plus intraoperative hemoadsorption (HA) with CytoSorb (n=75).
Primary outcome: Postoperative vasopressor requirements assessed by the Vasoactive-Inotropic Score (a well-established and accepted measure of vasopressor support required to manage hemodynamic instability) was significantly reduced in the CytoSorb group at 6, 12, 24, 48 and 72 hours (p<0.02 for all), consistent with improved hemodynamic stability after surgery
Secondary outcomes: Sepsis-related mortality was significantly reduced in the CytoSorb group (8.0% vs. 21.8%, p=0.02), as was overall 30-day (17.3% vs. 32.7%, p=0.03) and 90-day mortality (21.3% vs. 40%, p=0.03). This marked effect on mortality translated into a Number Needed to Treat (NNT) of just 5 patients to save a life.
The authors summarized the results as: "1) Mortality following cardiac surgery in infective endocarditis, particularly caused by S. aureus, is still high; 2) Intraoperative cytokine adsorption leads to improved postoperative hemodynamics, 3) Improved survival in patients treated by intraoperative adjunctive hemoadsorption" and concluded that: "Hemoadsorption with CytoSorb seems to be a safe and effective adjunctive therapy in Staphylococcus aureus infective endocarditis during cardiac surgery."
Dr. Daniel Wendt, Vice President - Medical Affairs Cardiovascular at CytoSorbents, stated, "The selection of this study for presentation in the main scientific program highlights the importance of these findings. As these results clearly demonstrate, CytoSorb can address some of the biggest management challenges in these very high risk endocarditis patients."
CytoSorbents also hosted a lunch symposium entitled, "Hemoadsorption with CytoSorb in high-risk cardiac surgery indications – new data" that drew approximately 150 attendees and was chaired by Professors Christophe Baufreton (Angers, France) and Piotr Suwalski (Warsaw, Poland). Key presentations included:
"Clinical benefits in patients undergoing heart transplantation – results of a single center RCT." Dr. Endre Németh (Budapest, Hungary) presented the results of the first ever randomized, controlled trial (RCT) using CytoSorb intraoperatively during cardiac transplantation.
Study population: 55 patients were randomized 1:1 to either standard of care (SOC) or SOC plus CytoSorb. Baseline characteristics were well-balanced between the two groups, including mean recipient age of 56 years in both arms and donor heart age of approximately 10 years less. Approximately half of the patients suffered from idiopathic cardiomyopathy and approximately one third from ischemic cardiomyopathy. Both cardiopulmonary bypass duration (SOC 129 [104-169] vs. SOC + CytoSorb 133 [116-165] minutes, p=ns) and total ischemic time (SOC 173±41 vs. SOC + CytoSorb 152±45 minutes, p=ns) were similar.
Primary outcome: Need for vasopressors to support blood pressure as measured by the Vasoactive Inotropic Score (VIS) was significantly reduced by CytoSorb (p=0.046), driven by reductions in both noradrenaline and vasopressin requirements. Importantly, this resulted in significantly lower rates of vasoplegia or vasodilatory shock (SOC 48% vs. SOC + CytoSorb 20%; 58% relative risk reduction (RRR), p=0.028) and shorter overall duration of vasopressor support (p=0.046).
Secondary outcomes: All clinical secondary endpoints evaluated in the trial were either similar between the two groups or statistically superior with SOC + CytoSorb including less time on mechanical ventilation (SOC 65 [23-287] vs. 25 [19-68.8] hours, p=0.025), lower rates of postoperative acute kidney injury (SOC 76% vs. SOC + CytoSorb 36.7%; RRR 52%, p=0.004) and fewer days in the ICU (SOC 12 [8.5-18] vs. 8.5 [8-10.3] days, p=0.022). Importantly, there were no differences in all rejection markers evaluated at 30 days, while there were 2 deaths in the SOC group and no deaths in the CytoSorb group.
Based on these RCT data, the authors concluded that proactive intraoperative CytoSorb use in patients undergoing heart transplantation resulted in important improvements in clinical and economic outcomes, including: 1) Significantly improved postoperative hemodynamic stability with reduced severity and duration of vasoplegia, 2) Significantly lower rates of postoperative acute kidney injury, 3) Significantly shorter time on postop mechanical ventilation, and 4) Significant reduction in ICU stay.
"Removal of antithrombotic drugs to reduce bleeding complications and costs in high urgency operations." Professor Michael Schmoeckel (Hamburg, Germany) presented previously published data demonstrating significant bleeding reductions with the intraoperative use of CytoSorb for antithrombotic drug removal in 55 patients undergoing urgent coronary artery bypass grafting (CABG) and 21 patients undergoing urgent type A aortic dissection repair who were either on ticagrelor or rivaroxaban at the Asklepios St. Georg Klinik in Hamburg, Germany
Key Outcomes: Among CABG patients, the use of CytoSorb was associated with significant reductions in 24-hour chest tube drainage (relative risk reduction [RRR] 60%; p=0.004), platelet (RRR 67%; p=0.048) and red blood cell transfusions (RRR 67; p=0.012) and need for re-operation (RRR 100%; p=0.0003). Total operative time was also significantly reduced (RRR 15%; p=0.004) and patients who underwent antithrombotic removal with CytoSorb spent 2 fewer days in the ICU (RRR: 50%; p=0.014) and 5 fewer days overall in the hospital (RRR 31%; p=0.024). Similar types and magnitude of benefits were also observed in patients undergoing antithrombotic removal during aortic dissection surgery, but due to the smaller sample size, statistical significance was only achieved for reduction in 24-hour chest tube drainage (RRR 47%, p<0.001) and platelet transfusions (RRR 31%, p=0.049).
Cost Benefit: A boot strap analysis on the 55 CABG patients, investigating the budget impact of CytoSorb use for antithrombotic removal, demonstrated CytoSorb to be a dominant therapy resulting in both clinical benefit and also substantial cost-savings. Specifically, each use of CytoSorb was associated with median budget savings of approximately € 4,200 (including the cost of the device), driven primarily by less operative time and shorter ICU stays.
"CytoSorb in infective endocarditis patients – what can we learn from recent data?" Professor Matthias Thielmann (Essen, Germany) followed his presentation in the main scientific session of the conference by providing a summary of recently published data from different studies at the West German Heart & Vascular Center, highlighting the use of CytoSorb in cardiac surgery applications to mitigate the harmful effects of surgery.
Publication on "Intraoperative hemoadsorption in patients with native mitral valve infective endocarditis" in 58 consecutive patients (CytoSorb, n=30; Control, n=28) showed that CytoSorb led to a significant reduction in the need for vasopressors, a reduced incidence of postoperative sepsis (Control 39.2% vs CytoSorb 16.7%, p=0.05), and a significant reduction in sepsis-related mortality (Control 18% vs CytoSorb 0%, p=0.02) in this well-defined population.
Publication on "Extracorporeal cytokine adsorption: Significant reduction of catecholamine requirement in patients with AKI and septic shock after cardiac surgery" detailed a case series of 98 high-risk cardiac surgery patients who developed postoperative acute kidney injury and sepsis, and were treated by postoperative continuous renal replacement therapy (CRRT) plus 15 hours of adjunctive hemoadsorption with CytoSorb. In this trial, that involved the Department of Nephrology at the University of Essen in a team-based, patient-centric approach, patients demonstrated a rapid and significant decrease of lactate levels and vasopressor support.
Publication on "Intraoperative hemoadsorption in high-risk patients with infective endocarditis" evaluated a series of 70 high-risk patients undergoing cardiac surgery for infective endocarditis. In a propensity-score matched comparison (35 vs. 35 patients), the SOFA-score normalized significantly faster over a 7-day period in the CytoSorb treated group, among other benefits.
Professor Thielmann then commented on the results of the REMOVE endocarditis trial and compared them to the latest data from the University of Nuremberg and Essen and concluded that patient selection in infective endocarditis is crucial, especially since high-risk patients, such as those with SAE, are likely to benefit most from adjunctive hemoadsorption techniques. Professor Thielmann concluded by stating that CytoSorb is the only new concept in the surgical treatment of infective endocarditis in many years, and has been used routinely for this indication at his institution.
Dr. Wendt added, "I was delighted to attend the annual EACTS meeting in person this year and was impressed by my discussions with so many highly-motivated and experienced cardiac surgeons and intensivists from all over the world who are using CytoSorb during and after cardiothoracic surgery. From Hamburg to Madrid, Budapest to Rome, and Warsaw to Paris, clinical adoption of CytoSorb is rapidly increasing as cardiac surgeons recognize the significant benefits of using hemoadsorption in their most challenging cases. With more data coming from multiple investigator-initiated trials, as well as our own company-sponsored studies, we anticipate that this momentum will only grow stronger in the future. As a busy academic cardiac surgeon, I had the opportunity to use CytoSorb in my most challenging cases for many years and witnessed first-hand its value in my practice. In my current role, my top priority is to make our key enabling technology the new standard in cardiac surgery around the world."
Dr. Efthymios Deliargyris, Chief Medical Officer of CytoSorbents concluded, "The new data presented at this year's EACTS conference validate our conviction that our proprietary hemoadsorption therapy is a "game-changing" intervention in cardiac surgery. The clinical benefits ranging from reversing shock and stabilizing patients postoperatively, to shorter ICU stays for heart transplant patients, to significantly less bleeding in patients on antithrombotic drugs undergoing high risk surgery, to reductions in mortality in the sickest endocarditis patients, speak to the power of our technology. These data support a robust clinical and economic value proposition that directly translates to significantly better outcomes and cost savings to heart centers around the world. We remain laser-focused on our clinical efforts to continue generating high quality evidence in cardiac surgery and are committed to making our technology available to U.S. centers with the execution of our currently ongoing pivotal STAR-T and STAR-D trials under FDA Breakthrough Device Designation."
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces "cytokine storm" or "cytokine release syndrome" in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to postoperative complications, including multiple organ failure. As of June 30, 2022, more than 179,000 CytoSorb devices have been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The company has initiated two FDA-approved pivotal studies to support FDA marketing approval of DrugSorb-ATR in the United States. The first is the randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at 30 centers to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. The second study is the STAR-D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial of 120 patients at 30 centers evaluating the intraoperative use of DrugSorb-ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery and taking direct oral anticoagulants, including apixaban and rivaroxaban.
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 $48 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb™-ATR, ContrastSorb, 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.
https://ih.advfn.com/stock-market/NASDAQ/cytosorbents-CTSO/stock-news/89277480/cytosorbents-reports-new-cardiac-surgery-data-with
Use of CytoSorb© Hemoadsorption in Patients on Veno-Venous ECMO Support for Severe Acute Respiratory Distress Syndrome: A Systematic Review
by Ali Akil 1ORCID,L. Christian Napp 2ORCID,Cristina Rao 3ORCID,Teresa Klaus 3,Joerg Scheier 3 andFederico Pappalardo 4,*
1. Department of Thoracic Surgery and Lung Support, Ibbenbueren General Hospital, 49477 Ibbenbueren, Germany
2. Department of Cardiology and Angiology, Hannover Medical School, 30625 Hannover, Germany
3. CytoSorbents Europe GmbH, 12587 Berlin, Germany
4. Cardiothoracic and Vascular Anesthesia and Intensive Care, AO SS. Antonio e Biagio e Cesare Arrigo, 15100 Alessandria, Italy
*Author to whom correspondence should be addressed.
Academic Editor: Daniel Wendt
J. Clin. Med. 2022, 11(20), 5990; https://doi.org/10.3390/jcm11205990 (registering DOI)
Received: 25 August 2022 / Revised: 30 September 2022 / Accepted: 4 October 2022 / Published: 11 October 2022
(This article belongs to the Special Issue Current Trends in Hemoadsorption Therapy)
Abstract
Acute respiratory distress syndrome (ARDS) is associated with high morbidity and mortality. Adjunct hemoadsorption is increasingly utilized to target underlying hyperinflammation derived from ARDS. This article aims to review available data on the use of CytoSorb© therapy in combination with V-V ECMO in severe ARDS, and to assess the effects on inflammatory, laboratory and clinical parameters, as well as on patient outcomes. A systematic literature review was conducted and reported in compliance with principles derived from the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. When applicable, a before-and-after analysis for relevant biomarkers and clinical parameters was carried out. CytoSorb© use was associated with significant reductions in circulating levels of C-reactive protein and interleukin-6 (p = 0.039 and p = 0.049, respectively). Increases in PaO2/FiO2 reached significance as well (p = 0.028), while norepinephrine dosage reductions showed a non-significant trend (p = 0.067). Mortality rates in CytoSorb© patients tended to be lower than those of control groups of most included studies, which, however, were characterized by high heterogeneity and low power. In an exploratory analysis on 90-day mortality in COVID-19 patients supported with V-V ECMO, the therapy was associated with a significantly reduced risk of death. Based on the reviewed data, CytoSorb© therapy is able to reduce inflammation and potentially improves survival in ARDS patients treated with V-V ECMO. Early initiation of CytoSorb© in conjunction with ECMO might offer a new approach to enhance lung rest and promote recovery in patients with severe ARDS.
Keywords: hemoadsorption; ARDS; lung failure; inflammation; CytoSorb; ECMO
https://www.mdpi.com/2077-0383/11/20/5990
So now Google Jason Kolbert of Dawson James. He's reiterating his "Buy" rating. The problem? Like my previous Sean Lee post, he is atrocious as an analyst. Ranked 7150 out of 7900. Do any successful people put a rec on CTSO? The headline makes us all feel good until you dig a little.
That's one inept incompetent down, several more to go (at a minimum).
NEWS -- CytoSorbents Announces Pending Retirement of Chief Financial Officer Kathleen P. Bloch
PRINCETON, N.J., Oct. 7, 2022 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced today that its Chief Financial Officer, Kathleen P. Bloch, MBA, CPA, plans to retire on March 31, 2023 at age 68, following a distinguished decade-long career at the Company. A search has been initiated for Ms. Bloch's replacement. Meanwhile, following her retirement next year, Ms. Bloch will continue as a consultant of the Company to provide, among other services, continuity during the transition of her successor.
Ms. Bloch stated, "It has been a privilege and a pleasure to be a part of the incredible team at CytoSorbents over the past 9 plus years, during which time we have achieved rapid growth in both our company and our business, while helping to save the lives of patients around the world. It has been an exciting and personally fulfilling journey, made more enjoyable by the positive chemistry and culture of our management team and employee base, which is a major reason why I have postponed my retirement for so long. But I am pleased to have been a major contributor, and look back on the accomplishments of my talented and highly capable finance and accounting teams in both the U.S. and Europe with pride. I believe the Company has an exciting future ahead, and look forward to an anticipated return to sales growth and the achievement of our first U.S. FDA marketing approval. Although I will retire formally at the end of March next year, I intend to continue supporting the Company from the sidelines as both a long-term shareholder and as a consultant as needed."
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, "Kathy is an outstanding CFO and member of our leadership team, and we are extremely fortunate to have her. Among Kathy's many accomplishments, she was instrumental in our successful up-listing to Nasdaq. As CFO of a public company, Kathy has also been responsible for timely and consistent accounting, SEC reporting, and Sarbanes Oxley compliance, and has worked diligently to design and strengthen our system of internal controls. Kathy was also key in the capitalization of our company by supporting numerous successful fund raisings in cumulative excess of $140 million and establishing a favorable debt facility, enabling us to finance the global expansion of our business to 75 countries and to build a state-of-the-art manufacturing facility. Through maintenance of a strong network of investors, bankers, and analysts, and presentations and investor meetings at numerous conferences, Kathy supports analyst coverage from six investment banks, and has been a welcomed partner in our investor relations outreach. Meanwhile, she has developed, mentored, and led an outstanding group of finance and accounting professionals who expertly manage a broad and complex range of international trade and accounting issues, from consolidation of subsidiary results based in different currencies, to international tax policies. Lastly, Kathy has overseen the modernization of our finance and accounting information technology systems to support our growing needs."
"We are also very proud of Kathy's well-deserved accomplishments outside of the Company. Kathy was the 2016 NJ BIZ Magazine's Public Company CFO of the Year, currently serves as Chapter President and Member of the Board of Directors of the Mercer Chapter of the New Jersey Society of Certified Public Accountants (NJCPA), and was the recipient of the 2021 NJCPA Ovation Award recognizing CPAs who have had an impact on their jobs, communities, and the accounting profession."
Dr. Chan concluded, "Above all, Kathy has been a tremendous pleasure to work with as a trusted colleague who embodies the values of our Company as a positive, kind, committed, and generous leader who puts our people and our mission ahead of herself. We feel honored to cap her outstanding financial executive career in successful private and public companies, and will miss her greatly. On behalf of the entire Company and our Board of Directors, we thank Kathy for her many years of dedication and service to the Company and wish her all the best in retirement and in this next phase in her life."
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces "cytokine storm" or "cytokine release syndrome" in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to postoperative complications, including multiple organ failure. As of June 30, 2022, more than 179,000 CytoSorb devices have been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The company has initiated two FDA-approved pivotal studies to support FDA marketing approval of DrugSorb-ATR in the United States. The first is the randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at 30 centers to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. The second study is the STAR–D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial of 120 patients at 30 centers evaluating the intraoperative use of DrugSorb-ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery and taking direct oral anticoagulants, including apixaban and rivaroxaban.
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 $48 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb™-ATR, ContrastSorb, and others. For more information, please visit the Company's websites at https://www.cytosorbents.com and https://www.cytosorb.com or follow us on Facebook and Twitter.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 10, 2022, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
CytoSorbents Contact:
Kathleen Bloch
(732) 398-5429
mailto://kbloch@cytosorbents.com
U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
mailto://ekim@rubensteinpr.com
View original content to download multimedia: https://www.prnewswire.com/news-releases/cytosorbents-announces-pending-retirement-of-chief-financial-officer-kathleen-p-bloch-301643417.html
SOURCE CytoSorbents Corporation
8-K just filed, "retire from her role as CFO" Kathleen Bloch.
On September 30, 2022, Ms. Kathleen P. Bloch notified CytoSorbents Corporation (the “Company”) and the Board of Directors (the “Board”) of her decision to retire from her role as Chief Financial Officer of the Company, effective as of March 31, 2023. Ms. Bloch and the Company currently expect to enter into a consulting arrangement under which Ms. Bloch will continue to provide services to the Company in a limited capacity following the effective date of her retirement. Ms. Bloch has also agreed to assist the Company during its transition to a replacement Chief Financial Officer. On October 7, 2022, prior to market open, the Company intends to formally issue a press release announcing Ms. Bloch's retirement, a copy of which is included as Exhibit 99.1 hereto.
https://ih.advfn.com/stock-market/NASDAQ/cytosorbents-CTSO/stock-news/89242335/current-report-filing-8-k
CytoSorbents Awarded an Approximately $4.3M Contract by the U.S. Department of Defense to Develop HemoDefend-BGA™ for Freeze-Dried Universal Plasma
October 06 2022 - 07:00AM
PR Newswire (US)
PRINCETON, N.J., Oct. 6, 2022 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader specializing in blood purification, announced today that the U.S. Army Medical Research Acquisition Activity (USAMRAA) has awarded the Company a three-year Phase III contract valued at $4,292,641 to customize the design of the HemoDefend-BGA™ filter for sterile integration into collections systems for freeze-dried plasma processing to generate freeze-dried universal plasma. Without the need for blood typing, widespread availability of universal plasma could help save lives via faster emergency treatment in both civilian and military settings.
Dr. Maryann Gruda, PhD, Principal Investigator and Senior Director of Biology at CytoSorbents stated, "We are excited to begin this phase of our development program. The continued support and funding of our anti-A and anti-B blood group antibody (BGA) reduction technology by the Defense Health Agency and U.S. Army will be instrumental in bringing this technology to market. This award will fund the development and scale-up of a specialized HemoDefend-BGA filter that can be integrated with freeze-dried plasma technologies to generate a logistically superior, low titer plasma product that can be administered to anyone, irrespective of blood type, while maintaining critical coagulation activity."
Dr. Phillip Chan, MD, PhD, Chief Executive Officer of CytoSorbents stated, "Freeze-dried plasma is dry and lightweight, stable for up to 2 years at room temperature, and can be quickly reconstituted with sterile water when needed. However, it currently remains a blood-type specific product, complicating its use. HemoDefend-BGA can remove blood-type specific antibodies from single donor or pooled plasma prior to freeze-drying, with the goal of ultimately producing a 'one-size-fits-all' freeze-dried universal plasma – a major advance. Such a product would also eliminate the need for cold-chain storage – greatly simplifying battlefield logistics and enabling first responders to provide mobile/remote emergency resuscitation in civilian trauma."
The HemoDefend-BGA filter is not yet approved in the U.S. or elsewhere. This award was supported by the Defense Health Agency (DHA) Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) Programs/Joint Warfighter Medical Research Program (JWMRP) under U.S. Army Medical Research Acquisition Activity (USAMRAA) Contract No. W81XWH-22-C-0046. The award is entitled "Integrating Isoagglutinin Reduction for a Universal Dried Plasma Product for Battlefield and First Responder Use." The outcome of this award is expected to be the large-scale manufacturing of the active polymer for subsequent integration of the device into the plasma freeze-drying process.
The content of this press release is solely the responsibility of the authors and any opinions, findings, and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the Department of Defense, DHA, SBIR/STTR Programs, JWMRP, or USAMRAA.
About HemoDefend-BGA™
CytoSorbents is developing HemoDefend-BGA to enable both universal plasma and fresh whole blood transfusions through the reduction of anti-A and anti-B blood group antibodies via our advanced blood purification technology. Today, plasma and whole blood products must be carefully blood-type matched to prevent potentially fatal hemolytic transfusion reactions in the recipient, caused by the accidental administration of mismatched blood products. The reduction of anti-A and anti-B antibodies could potentially reduce or eliminate this risk, allowing for a broader range of available donors and simplifying the transfusion process. According to the American Red Cross, nearly 10,000 units of plasma are needed daily in the United States, or more than 3.5 million units a year. The World Health Organization (WHO) reports that plasma is transfused at a rate of 2.2 – 18.9 units per 1,000 population (median 7.7 units) globally. In westernized countries alone, with a population of 1.5 billion, there are approximately 12 million units of plasma administered each year. The total addressable market for HemoDefend-BGA in transfusion medicine in westernized countries alone is an estimated $400 million to $600 million and represents a fraction of the global market.
CytoSorbents Contact:
Kathleen Bloch
(732) 398-5429
kbloch@cytosorbents.com
U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
ekim@rubensteinpr.com
https://ih.advfn.com/stock-market/NASDAQ/cytosorbents-CTSO/stock-news/89237498/cytosorbents-awarded-an-approximately-4-3m-contra
Because we have an academic/MD for a CEO. Two different cultures.
This kid was a mess. That the CTSO filter contributed to saving him is amazing. Why can't we sell these filters?
Case of the Week
Literature Database
Intraoperative use of CytoSorb in a mitral valve replacement redo procedure due to infective endocarditis
Darío Andrade1, David Orozco-Vinasco2 | 1Department of Cardiac Surgery, Clínica Colsubsidio Calle 100, Bogota, Colombia | 2Department of Cardiovascular Anesthesia, Clínica Colsubsidio Calle 100, Bogota, Colombia
10/05/2022
Reduction in catecholaminesAnticoagulation HeparinCardiac surgeryCase of the weekCase reportCPBEndocarditisInflammatory parametersIntra-Op
Download documentDownload document
Summary
CoW 34/2021 – This case reports on a 18-year-old male patient, who was admitted to a secondary hospital due to febrile symptoms (38.5-39°C) and headache with deterioration of his neurological status (bradypsychia, deviation of gaze and vomiting) after outpatient antibiotic management following suspected neuro-infection.
Case presentation
Known medical history included Marfan syndrome, bacterial endocarditis at the age of 16 as well as mitral valve replacement with a mechanical prosthesis 8 months before the current hospitalization
Antibiotic therapy at this time point consisted of vancomycin (870 mg every 12 hours), rifampicin (300 mg every 8 hours) and gentamicin (60 mg iv every 8 hours)
Following admission, he was evaluated and after diagnostic brain CT imaging and laboratory analysis, initial working diagnosis was either endocarditis and/or septic embolism in the brain
Due to his medical history, he was then referred to the Clínica Colsubsidio Calle 100, Bogota, being a tertiary referral centre
Subsequent transesophageal echocardiography showed preserved contractility and systolic function, with a left ventricular ejection fraction (LVEF) of 58%, mechanical prosthesis in mitral position with elevated transvalvular gradients, echo-dense mass described in anterior portion of prosthetic ring compatible with a vegetation, and at least moderate anterior paravalvular leak
Over the following 4 days, the patient was evaluated for potential surgical treatment. However, due to the unknown etiology of his cerebrovascular event, additional studies were performed including checks for potential infectious diseases (e.g. COVID-19), and more advanced laboratory tests
Contrast magnetic resonance imaging (MRI) then confirmed an ischemic event in the late subacute evolutionary phase of probable embologenic etiology (septic) being the most likely cause, however micro-abscesses were also considered as differential diagnosis
Four days later, further neurological examinations reconfirmed an ischemic acute cerebrovascular event without hemorrhagic transformation and micro-abscesses. The antimicrobial management was deemed appropriate and was proposed to be continued for at least 4 weeks
Prior to surgery, the patient showed profound hemodynamic instability with a decreased systemic vascular resistance index (SVRI, 620 dyn*s*cm5*m²) requiring massive doses of vasopressors (vasopressin 3 IU/h, norepinephrine 0.5 µg/kg/min)
Additionally, hemodynamic disturbances translated into profound lactic acidosis (4.4 mmol/l)
As there were no contraindications for surgery nor for the use of anticoagulants, the redo procedure was scheduled for the next day and consisted of mitral valve replacement (MVR) with a mechanical prosthesis and tricuspid annuloplasty
Given the young age of the patient, his extensive medical history, the infectious profile as well as the hemodynamic instability, a CytoSorb hemoadsorber was integrated into the cardiopulmonary bypass (CPB) circuit with the rationale to stabilize hemodynamics and to reduce the hyperinflammatory response, which was anticipated would be triggered by this major procedure in a patient with considerable cardiac history
Treatment
CytoSorb was used in conjunction with the cardiopulmonary bypass machine (SARNS 8.000, Terumo. Additionally BP-80 Centrifugal pump, Medtronic) for a period of 100 minutes, cross clamp time was 90 min
Anticoagulation: heparin
Blood flow rate: 500 ml/min
ACT: 418 – 527 – 483 – 144 sec
Total heparin: 32,500 IU
Protamine: 30,000 IU
Ultrafiltration rate: 2.200 cc
Administered blood components during surgery: 2x fresh frozen plasma, 6x cryoprecipitate, 1x red blood cell concentrate
Measurements
Hemodynamics and catecholamine requirements
Lactate values
Inflammatory parameters
Postoperative bleeding rate
Results
Perioperatively, his vasopressor demand increased transiently and dobutamine had to be added. However, already 60 minutes after completion of the procedure, dosages of vasopressors could be decreased considerably (vasopressin 1 IU/h, norepinephrine: 0.05 µg/kg/min). Six hours after the procedure, vasopressin and norepinephrine infusion could be stopped and dobutamine was kept at 2.5 µg/kg/min to support contractility
This was accompanied by a decrease in plasma lactate concentrations from 4 mmol/l pre-treatment to 2.9 mmol/l during CPB and 2.5 mmol/l post CPB
Also levels of C-reactive protein (CRP) decreased under CytoSorb therapy: CRP pre 77 mg/l, CRP during CPB 3.3 mg/l, CRP post CPB 2.8 mg/l
Patient Follow-Up
Extubation 12 hours after leaving the operating theatre
Clinical evidence of good peripheral perfusion
No bleeding complications occurred and surgical drains were removed after 48 hours
Examination of valve cultures later confirmed colonization with S. hominis so it was decided to maintain antibiotic treatment with vancomycin for another 6 weeks
The patient developed a complete AV block postoperatively, and the electrophysiology department opted for permanent pacemaker implantation, while neurology recommended continuation of treatment initially in the intensive care unit
Transfer of the patient to the normal ward 6 days after the procedure and back home 9 days later with continued antibiotic and anticoagulation therapy
Conclusion
The intraoperative use of CytoSorb incorporated into the CPB circuit in this patient with infective endocarditis undergoing a mitral valve replacement redo procedure was associated with an improvement of the perioperative hemodynamic situation accompanied by resolution of lactic acidosis and control of the anticipated hyperinflammatory response
Due to the excellent results both in modulation of the inflammatory response and in the postoperative bleeding rate, the surgical team now routinely consider the intraoperative use of CytoSorb in patients with a diagnosis of infective endocarditis
Integration into the CPB circuit was easy and safe. No adverse events were recorded.
Google this guy Sean Lee. His record and rating is atrocious. I wish it wasn't so, but it is. But don't take my word for it. Check yourself.
H.C. Wainwright Reaffirms Their Buy Rating on Cytosorbents (CTSO)
September 28 2022 - 06:25AM
TipRanks
H.C. Wainwright analyst Sean Lee CFA maintained a Buy rating on Cytosorbents ( – ) today and set a price target of $9.00. The company’s shares closed yesterday at $1.39.
Lee CFA covers the Healthcare sector, focusing on stocks such as Plus Therapeutics, Verastem, and Cytosorbents. According to , Lee CFA has an average return of -22.9% and a 16.49% success rate on recommended stocks.
Currently, the analyst consensus on Cytosorbents is a Moderate Buy with an average price target of $16.00.
CTSO market cap is currently $60.57M and has a P/E ratio of -1.70.
TipRanks has tracked 36,000 company insiders and found that a few of them are better than others when it comes to timing their transactions. See which are most likely to make moves following their insider activities.
CytoSorbents Corp. engages in the research and development of blood purification technology for the reduction of deadly uncontrolled inflammation in hospitalized patients. Its product include CytoSorb, ContrastSorb, HemoDefend, VetResQ, and DrugSorb. The company was founded by Joseph Rubin on April 25, 2002 and is headquartered in Monmouth Junction, NJ.
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TipRanks is a comprehensive investing tool that allows private investors and day traders to see the measured performance of anyone who provides financial advice.
https://www.tipranks.com/news/blurbs/h-c-wainwright-reaffirms-their-buy-rating-on-cytosorbents-ctso?utm_source=advfn.com&utm_medium=referral
My Cousin Vinny quoted in the PR! How about that!?!(Mel Allen). Vinny, ignore all those posts calling you inept, incompetent, a fool etc. You're worth every penny of that $1.7 million package. Useless clown.
NEWS -- CytoSorbents Achieves ISO 13485 Certification of Princeton Manufacturing Facility in New Jersey
PRINCETON, N.J., Sept. 27, 2022 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced today that it has received ISO 13485 Certification of its new manufacturing facility in Princeton, New Jersey from its European Union (E.U.) notified body, clearing the way for full manufacturing of CytoSorb®, DrugSorb®-ATR, and ECOS-300CY® from this site, with capacity to add additional product lines as they are developed.
Mr. Vincent Capponi, President and Chief Operating Officer of CytoSorbents stated, "We are very excited to receive this certification, which represents another key milestone in our company development and commercialization story. Our manufacturing, engineering, quality, and regulatory teams deserve the credit for this significant accomplishment. This state-of-the-art facility expands our manufacturing capacity to support up to $350-400 million in sales of our commercialized products, and will be a key component in the regulatory application and expected commercial launch of DrugSorb-ATR in the United States."
CytoSorb is an advanced blood purification cartridge approved in the E.U. and distributed in 75 countries worldwide to remove cytokines (inflammation), bilirubin (liver failure), and myoglobin (trauma), from blood. CytoSorb is also E.U. approved to remove the antithrombotic "blood thinning" drugs, Brilinta® (ticagrelor, Astra Zeneca) and Xarelto® (rivaroxaban, Janssen, Bayer) during cardiothoracic surgery to reduce the risk of perioperative bleeding.
DrugSorb-ATR is an investigational blood purification cartridge that uses an equivalent polymer technology to CytoSorb, and is in two pivotal U.S. randomized, controlled clinical trials under dual FDA Breakthrough Device Designations, to remove Brilinta® (STAR-T; Safe and Timely Antithrombotic Removal – Ticagrelor) and the direct oral anticoagulants (DOACs), Eliquis® (apixaban, Pfizer, BMS) and Xarelto® (STAR-D, - DOAC), intraoperatively during cardiothoracic surgery to reduce the risk of perioperative bleeding with the goal of achieving FDA marketing approval. The STAR-T trial is enrolling well and is expected to reach the first milestone with 40 patients enrolled within the next couple of months that will trigger the first Data and Safety Monitoring Board (DSMB) meeting.
ECOS-300CY® is approved in the E.U. as a cytokine adsorber for ex vivo organ perfusion machines used in solid organ transplant to reduce circulating cytokines and other inflammatory mediators. The goal of the therapy is to improve the functioning of substandard organs, potentially increasing the pool of donated organs and reduce the waiting list for transplant.
ISO 13485 was written to support medical device manufacturers in designing a quality management system (QMS) that establishes and maintains the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery through to disposal of medical devices that are safe for their intended purpose.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in more than 70 countries worldwide. It is an extracorporeal cytokine adsorber that reduces "cytokine storm" or "cytokine release syndrome" in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to postoperative complications, including multiple organ failure. As of June 30, 2022, more than 179,000 CytoSorb devices have been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The company has initiated two FDA-approved pivotal studies to support FDA marketing approval of DrugSorb-ATR in the United States. The first is the randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at 30 centers to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. The second study is the STAR-D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial of 120 patients at 30 centers evaluating the intraoperative use of DrugSorb-ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery and taking direct oral anticoagulants, including apixaban and rivaroxaban.
CytoSorbents' purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other body fluids through pore entrapment and surface adsorption. The company's technologies have received more than $41.5 million in non-dilutive grants, contracts and other non-dilutive funding from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), the National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC) and others. The company has numerous marketed and in-development products based on this unique blood purification technology protected by numerous issued U.S. and international patents and registered trademarks, as well as several pending patent applications, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb™-ATR, ContrastSorb and others. For more information, please visit the company's websites at https://www.cytosorbents.com and https://www.cytosorb.com or follow us on Facebook and Twitter.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 10, 2022, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
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Investor Relations Contact:
Amy Vogel
(732) 398-5394
mailto://avogel@cytosorbents.com
U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
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SOURCE CytoSorbents Corporation
Less than 0.05 cents presplit!
Any cheerleaders with pom poms “backing up the truck” to take advantage of the outstanding opportunity today’s yearly low is providing? Oh, and before you accuse me of being a short, all I can say is “I wish!”
CEO just made a sizable insider buy of 35k shares on the open market, and now exceeds 4% ownership:
https://www.sec.gov/Archives/edgar/data/1175151/000110465922099104/xslF345X03/tm2225533-1_4seq1.xml
The U.S. Department of Defense Awards CytoSorbents an Approximately $2.0M Contract to Support HemoDefend-BGA™ Development for Life-saving Universal Plasma
PRINCETON, N.J., September 9, 2022 — CytoSorbents Corporation (NASDAQ: CTSO) a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced today that the U.S. Army Medical Research Acquisition Activity, with funding from the Combat Casualty Care Research Program, awarded the Company a two-year grant (W81XWH-22-1-0235) valued at $1,977,024 to optimize development of the HemoDefend-BGA™ adsorber to a fully-finished, commercial device that will be evaluated in a pre-clinical porcine study for safety and efficacy. This Combat Casualty Care Research Program-funded research is a direct follow on to earlier development work funded through the Peer Reviewed Medical Research Program of the Congressionally Directed Medical Research Programs.
The HemoDefend-BGA adsorber can rapidly remove >99% of anti-A and anti-B antibodies from plasma to create a “universal plasma” that could be administered to anyone, irrespective of blood type, while maintaining critical coagulation activity. Without the need for blood typing, widespread availability of universal plasma could help save lives via faster emergency treatment in both civilian and military settings.
Dr. Maryann Gruda, Principal Investigator and Senior Director of Biology at CytoSorbents stated, “This funding from the U.S. Army will be used to complete the development of our anti-A and anti-B blood group antibody reduction technology. Through prior awards, we have worked to optimize the efficiency, robustness, and form factor of our HemoDefend-BGA adsorber, and look forward to taking what we believe is a transformative technology into large animal testing, where we will evaluate the safety and efficacy of universal plasma generated by HemoDefend-BGA. We are excited to begin this portion of the development program.”
Mr. Vincent Capponi, President and Chief Operating Officer of CytoSorbents indicated, “Our HemoDefend-BGA program has the potential to address a global need for universal plasma in both civilian and combat casualty care. This priority initiative continues to advance, benefitting from more than $11M in government contracts. Once the pre-clinical study and requisite benchtop testing are successfully completed, we plan to file a U.S. FDA pre-submission package to pursue human clinical trials with the goal of bringing this life-saving technology to the market.”
The HemoDefend-BGA Adsorber is not yet approved in the U.S. or elsewhere. The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office. This award was supported by the Assistant Secretary of Defense for Health Affairs endorsed by the U.S. Department of Defense (DoD), through the DoD Defense Health Program (DHP), Congressionally Directed Medical Research Programs (CDMRP), Defense Medical Research and Development Program, Joint Program Committee 6 Combat Casualty Care Research Program (CCCRP/JPC-6), Battlefield Resuscitation for Immediate Stabilization of Combat Casualties (BRISCC), in the amount of $1,977,024 under Award No. W81XWH-22-1-0235. The award is expected to optimize development of the HemoDefend-BGA adsorber via a preclinical animal study to evaluate safety and efficacy entitled “Demonstration of the Safety and Efficacy of Field-Ready Blood Group Antibody (BGA) Adsorber in a Porcine Universal Transfusion Model.” The content of this press release is solely the responsibility of the authors and any opinions, interpretations, conclusions, or recommendations expressed in this material are those of the author(s) and are not necessarily endorsed by the Department of Defense.
About HemoDefend-BGA™
CytoSorbents is developing HemoDefend-BGA to enable both universal plasma and fresh whole blood transfusions through the reduction of anti-A and anti-B blood group antibodies via our advanced blood purification technology. Today, plasma and whole blood products must be carefully blood-type matched to prevent potentially fatal hemolytic transfusion reactions in the recipient, caused by the accidental administration of mismatched blood products. The reduction of anti-A and anti-B antibodies could potentially reduce or eliminate this risk, allowing for a broader range of available donors and simplifying the transfusion process. According to the American Red Cross, nearly 10,000 units of plasma are needed daily in the United States, or more than 3.5 million units a year. The World Health Organization (WHO) reports that plasma is transfused at a rate of 2.2 – 18.9 units per 1,000 population (median 7.7 units) globally. In westernized countries alone, with a population of 1.5 billion, there are approximately 12 million units of plasma administered each year. The total addressable market for HemoDefend-BGA in transfusion medicine in westernized countries alone is an estimated $400 million to $600 million and represents a fraction of the global market.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification. Its flagship product, CytoSorb®, is approved in the European Union with distribution in more than 70 countries around the world as an extracorporeal cytokine adsorber designed to reduce the “cytokine storm” or “cytokine release syndrome” seen in common critical illnesses that may result in massive inflammation, organ failure and patient death. These are conditions where the risk of death can be extremely high, yet few to no effective treatments exist. CytoSorb is also being used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. More than 179,000 cumulative CytoSorb devices have been utilized as of June 30, 2022. CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind cytokine adsorber. Additional CE-Mark label expansions were received for the removal of bilirubin and myoglobin in clinical conditions such as liver disease and trauma, respectively, and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with imminent or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The Company has initiated two FDA approved pivotal trials designed to support U.S. marketing approval of DrugSorb-ATR. The first is the 120-patient, 30 center STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) randomized, controlled trial evaluating the ability of intraoperative DrugSorb-ATR use to reduce perioperative bleeding risk in patients on ticagrelor undergoing cardiothoracic surgery. The second is the 120-patient, 30 center STAR-D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial, evaluating the intraoperative use of DrugSorb-ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery on direct oral anticoagulants, including apixaban and rivaroxaban.
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 more than $41.5 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb-ATR™, ContrastSorb, 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.
Forward-Looking Statements
This press release contains forward-looking statements that fall within the safe harbor of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements regarding our plans, objectives, future goals and prospects for our business, expectations regarding the future impact of COVID-19 or the ongoing conflict between Russia and Ukraine, representations and assertions, and are not historical facts and are generally identified by the use of words such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar terms, although some forward-looking statements are worded differently. You should be aware that the forward-looking statements in this press release reflect management's current beliefs and expectations, but that our actual results, events and performance may differ materially from those in the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, the risks disclosed in our Annual Report on Form 10-K filed with the SEC on March 10, 2022, our Quarterly Reports on Form 10-Q and the press releases and other communications to stockholders that we issue from time to time seeking to inform interested parties of the risks and factors that may affect our business. We caution you not to place undue reliance on such forward-looking statements. We are under no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by federal securities laws.
Another news link on this is here:
https://markets.businessinsider.com/news/stocks/the-u-s-department-of-defense-awards-cytosorbents-an-approximately-2-0m-contract-to-support-hemodefend-bga-development-for-life-saving-universal-plasma-1031734352
The timeline, cost, and impact of those FDA approvals (assuming they happen) are the cause for concern. Market is pricing in serious dilution and my optimism that it can be avoided is waning fast. Best case we get an early positive result on STAR-T so we can raise money at higher stock price.
Bio, your optimism is admirable (and genuine I believe). I wish I could share it. I'm heavily invested, long, here. There is nothing indicating that the trials are proceeding timely. I posted at much higher prices that they should have sold the company. But why would these clowns do that while they suck the company dry? If panic hasn't set in at the headquarters IT SHOULD. We are in deep sh@t. Peace to you and good luck to us.
fantomphan, the ship has a rudder and is steering for 2 FDA approvals. You should get onboard.
This is a rudderless ship with these incompetents running things. Runaway spending like we're a successful company. So badly mismanaged.
Case report: Cytokine hemoadsorption in a case of hemophagocytic lymphohistiocytosis secondary to extranodal NK/T-cell lymphoma
Juan Carlos Ruiz-Rodríguez et al. Front Med (Lausanne). 2022.
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Front Med (Lausanne)
. 2022 Aug 15;9:925751.
doi: 10.3389/fmed.2022.925751. eCollection 2022.
Authors
Juan Carlos Ruiz-Rodríguez 1 2 3 , Luis Chiscano-Camón 1 2 3 , Adolf Ruiz-Sanmartin 1 2 3 , Clara Palmada 1 2 , Ivan Bajaña 1 2 , Gloria Iacoboni 3 4 , Camilo Bonilla 1 2 , Alejandra García-Roche 1 2 , Erika Paola Plata-Menchaca 1 2 3 , Carolina Maldonado 1 2 , Marcos Pérez-Carrasco 1 2 3 , Mónica Martinez-Gallo 3 5 6 7 , Clara Franco-Jarava 5 6 , Manuel Hernández-González 5 6 7 , Ricard Ferrer 1 2 3
Affiliations
1 Intensive Care Department, Vall d'Hebron University Hospital, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.
2 Shock, Organ Dysfunction and Resuscitation Research Group, Vall d'Hebron Research Institute (VHIR), Vall d'Hebron University Hospital, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.
3 Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain.
4 Hematology Department, Vall d'Hebron Hospital Universitari, Experimental Hematology, Vall d'Hebron Institute of Oncology (VHIO), Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.
5 Immunology Division, Vall d'Hebron University Hospital, Barcelona, Spain.
6 Diagnostic Immunology Research Group, Vall d'Hebron Research Institute, Barcelona, Spain.
7 Department of Cell Biology, Physiology and Immunology, Autonomous University of Barcelona (UAB), Barcelona, Spain.
PMID: 36045925
PMCID: PMC9423101
DOI: 10.3389/fmed.2022.925751
Cite
Abstract
We discuss a single case of Hemophagocytic lymphohistiocytosis (HLH) due to NK-type non-Hodgkin lymphoma and Epstein-Barr virus reactivation with multiorgan dysfunction and distributive shock in which we performed cytokine hemoadsorption with Cytosorb ®. A full microbiological panel was carried out, including screening for imported disease, standard serologies and cultures for bacterial and fungal infection. A liver biopsy and bone marrow aspirate were performed, confirming the diagnosis. The patients fulfilled the HLH-2004 diagnostic criteria, and according to the 2018 Consensus Statements by the HLH Steering Committee of the Histiocyte Society, dexamethasone and etoposide were started. There was an associated hypercytokinemia and, due to refractory distributive shock, rescue therapy with cytokine hemoadsorption was performed during 24 h (within day 2 and 3 from ICU admission). After starting this procedure, rapid hemodynamic control was achieved with a significant reduction in vasopressor support requirements. This case report highlights that cytokine hemoadsorption can be an effective since rapid decrease in IL-10 levels and a significant hemodynamic improvement was achieved.
New on PubMed
Use of Cytokine Filters During Cardiopulmonary Bypass: Systematic Review and Meta-Analysis
Vinci Naruka et al. Heart Lung Circ. 2022.
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Heart Lung Circ
. 2022 Aug 27;S1443-9506(22)01038-1.
doi: 10.1016/j.hlc.2022.07.015. Online ahead of print.
Authors
Vinci Naruka 1 , Mohammad Yousuf Salmasi 2 , Arian Arjomandi Rad 2 , Nandor Marczin 2 , George Lazopoulos 3 , Marco Moscarelli 2 , Roberto Casula 4 , Thanos Athanasiou 5
Affiliations
1 Department of Surgery and Cancer, Imperial College, London, UK; Department of Cardiothoracic Surgery, Hammersmith Hospital, London, UK.
2 Department of Surgery and Cancer, Imperial College, London, UK.
3 Department of Cardiothoracic Surgery, University Hospital of Heraklion, Crete, Greece.
4 Department of Cardiothoracic Surgery, Hammersmith Hospital, London, UK.
5 Department of Surgery and Cancer, Imperial College, London, UK; Department of Cardiothoracic Surgery, Hammersmith Hospital, London, UK. Electronic address: t.athanasiou@imperial.ac.uk.
PMID: 36041987
DOI: 10.1016/j.hlc.2022.07.015
Cite
Abstract
Introduction: Cardiac surgery involving cardiopulmonary bypass (CPB) activates an inflammatory response releasing cytokines that are associated with less favourable outcomes. This study aims to compare i) CPB during cardiac surgery (control) versus ii) CPB with haemoadsorption therapy; and assess the effect of adding this therapy in reducing the inflammatory cytokines burden.
Methods: A systematic literature review with metanalysis was conducted regarding the main outcomes (operative mortality, ventilation duration, intensive care unit [ICU] and hospital stays) and day-1 inflammatory markers levels post-surgery. Fifteen (15) studies were included for final analysis (eight randomised controlled trials, seven observational studies) with no evidence of publication bias.
Results: Subgroup analysis of non-elective surgeries across observational studies (emergency and infective endocarditis) significantly favoured cytokine filters in terms of 30-day mortality (OR 0.40, 95% CI 0.20, 0.83; p=0.01) and shorter ICU stay (MD -42.36, 95% CI -68.07, -16.65; p=0.001). At day-1 post-surgery, there was a significant difference favouring the cytokine filter group in c-reactive protein (CRP) (MD -0.71, 95% CI -0.84, -0.59; p<0.001) with no differences in white blood count (WBC), procalcitonin (PCT), tumour necrosis factor-alpha (TNF-a), IL-6, IL-8 and lactate. When comparing cytokine filters and control across all studies there was no significant difference in operative mortality, ventilation duration, hospital stay and ICU length of stay. Also, there were no statistical differences in randomised controlled trials (RCTs) using haemadsorption filters.
Conclusions: A significant reduction in 30-day mortality and ICU stay could be obtained by using haemadsorption therapy during non-elective cardiac surgery, especially emergency surgery and in patients with higher inflammatory burden such as infective endocarditis.
Eskay, on 4/6/20 you posted what you said was your last post.
Put a fork in CTSO! It’s done!
PR Newswire
Turkish Ministry of Health Grants National Reimbursement to CytoSorb®
The cost of treatment with CytoSorb® will now be covered by the public sector in Turkey
PRINCETON, N.J., Aug. 23, 2022 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced that the Turkish Ministry of Health has approved national reimbursement for CytoSorb®, which is now a reimbursed catalog product in the State Supply Office of Turkey (DMO) portal and can be purchased directly by hospitals and physicians without restrictions.
https://finance.yahoo.com/news/turkish-ministry-health-grants-national-110200872.html
Israeli Ministry of Health Approves National Coverage for CytoSorb®
Wed, August 17, 2022 at 7:02 AM
PRINCETON, N.J., Aug. 17, 2022 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced that the Israeli Ministry of Health (MoH) has approved national reimbursement for CytoSorb® in certain cardiac surgery indications that is expected to take effect in 2023.
Israeli Ministry of Health Adds CytoSorb Blood Purification Cartridge to Healthcare Basket with National Reimbursement
https://finance.yahoo.com/news/israeli-ministry-health-approves-national-110200187.html
Case of the Week
Literature Database
The successful application of hemoadsorption for extracorporeal liver support in a child with acute liver failure
Wun Fung Hui, Wing Lum Cheung, Fung Shan Chung, Karen Ka Yan Leung and Shu Wing Ku | Department of Paediatrics and Adolescent Medicine, Hong Kong Children’s Hospital, Kowloon, Hong Kong | Int J Artif Organs 2022; epub
08/17/2022
New!PediatricsPeer Reviewed Published DataSafetyBilirubinCase of the weekCase reportCritical CareCRRT (pre or post filter)Improv. hep. encephalopathy
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Summary
CoW 33/2022 – This case reports on a 6-year-old boy, who was admitted to the hospital due to prolonged dyskinetic movements resulting in rhabdomyolysis and acute kidney injury.
Summary
The following case report describes the use of CytoSorb in a pediatric patient for the reduction of hyperbilirubinemia and elevated serum bile acids in acute liver failure. A 6-year-old boy was admitted to hospital due to prolonged dyskinetic movements resulting in rhabdomyolysis and acute kidney injury. Over the following 10 days he was given multiple antibiotics for various infections and five days later developed acute liver failure with hepatic coma due to drug rash with eosinophilia and systemic symptoms (DRESS). He had hyperbilirubinemia, elevated serum bile acids and hyperammonemia as well as raised liver enzymes. Despite standard therapies his condition deteriorated, and he was admitted to the Pediatric Intensive Care Unit (PICU) for ongoing management. In addition to the use of systemic steroids and other supportive therapies, he was started on continuous renal replacement therapy (CRRT), into which a CytoSorb column was added as an extracorporeal liver support to try and reduce the bilirubin and bile acids. Three adsorbers were used for a total duration of 75 hrs (28, 22 and 25 hrs). Serum levels of total bilirubin reduced from 418 to 119 µmol/L, bile acids to from 174 to 58 µmol/L and ammonia reduced from 172 to 55 µmol/L. His conscious level gradually improved, as did his liver function. Except for mild, non-symptomatic thrombocytopenia and mild electrolyte disturbances, the therapy was well tolerated with no major complication encountered. He was finally able to be discharged from the PICU after 20 days. The authors state that hemoadsorption may have the merits of a faster initial rate of bilirubin removal and ease of set up compared to albumin dialysis. In summary this case demonstrates that hemoadsorption with CytoSorb can be safely employed as an adjunctive extracorporeal liver support modality in children with acute liver failure as it can efficiently remove bilirubin and bile acids. The potential role and technical concerns of applying such technique in pediatric patients requires further evaluation in future studies.
Case presentation
He was initially given ceftriaxone for potential central venous system infection. Later, his course was complicated by streptococcus mitis pneumonia resulting in the administration of vancomycin for 7 days. In the subsequent 10 days of hospitalization, he was given amoxicillin and clavulanic acid as well as piperacillin/tazobactam as empirical therapy for recurrence of fever, while all microbiological investigations showed no positive bacterial growth
Five days after stopping all antibiotics, he again developed low grade fever. He also had hepatomegaly, ascites and a generalized erythematous maculopapular rash associated with tender cervical lymphadenopathy
Blood tests revealed leukocytosis with white blood cell count 12.4×109/L, lymphocyte count 4.72×109/L, eosinophil count 0.37 × 109/L, and the presence of atypical lymphocytes
He also showed increased liver enzymes (serum levels of alanine aminotransferase [ALT] 1241 IU/L, alkaline phosphatase [ALP] 220 IU/L, aspartate aminotransferase [AST] 839 IU/L and gamma-glutamyl transferase [GGT] 160 IU/L), hypoalbuminemia (29 g/L), hyperbilirubinemia (25 µmol/L), and coagulopathy (international normalized ratio [INR] 1.49 and activated partial thromboplastin time [aPTT] 34.6 s). The ammonia level was <20 µmol/L
Ultrasound of the hepatobiliary system showed no focal hepatic lesions and no dilated biliary system
He was started on cefotaxime empirically, which was changed to meropenem 4 days later
Supportive treatment with vitamin K, albumin and fresh frozen plasma (FFP) was also commenced
However, serial investigations revealed evolving hepatic failure and he was subsequently transferred to the Pediatric Intensive Care Unit (PICU) for further management
Upon PICU admission, he was still arousable and his Glasgow Coma Scale (GCS) was 15, but he soon started to desaturate requiring high flow oxygen of 15 L/min
Multiple investigations were performed to try and determine the underlying cause of his acute hepatic failure. Finally, he was diagnosed with drug rash with eosinophilia and systemic symptoms (DRESS) syndrome (most probably due to previous exposure to multiple antibiotics, in particularly the beta-lactams) based on the RegiSCAR (Registry of Severe Cutaneous Adverse Reaction) criteria, with Wilson’s disease being an important differential diagnosis
Hence, all antibiotics were stopped after PICU admission
He was then given ursodeoxycholic acid and vitamin supplements for his cholestasis and lactulose to limit enteral ammonia absorption. His protein intake was limited to <1 g/kg/day
One dose of intravenous immunoglobulin was administered for potential Epstein-Barr virus infection
Methylprednisolone was also started 3 days after admission as a treatment for DRESS syndrome
Despite that, he continued to deteriorate with reduced conscious level (GCS dropped to 10) suggesting the development of grade three hepatic encephalopathy. Serum total bilirubin was 418 µmol/L, direct bilirubin 328 µmol/L, bile acids 174 µmol/L and ammonia levels had increased to 172 µmol/L, while INR increased to 3.12
There was also evolving bradycardia suggestive of bile acid-associated cardiac toxicity. The bedside echocardiogram showed normal contractility with a left ventricular fractional shortening of 37%
His highest Pediatric End-stage Liver Disease (PELD) score was 30 and he had a work up for potential liver transplant
Therefore, continuous renal replacement therapy (CRRT) was started for hyperammonemia 4 days after admission. In order to accelerate removal of bilirubin and bile acids, a CytoSorb hemoadsorption column was additionally integrated into the CRRT circuit
Treatment
Three adsorbers were used for a total duration of 75 hrs (28, 22 and 25 hrs)
Measurements
Bilirubin, bile acids, ammonia
Liver function
Level of consciousness
Coagulation profile
Platelets, electrolytes
Results
Under combined CRRT+CytoSorb treatment, serum levels of total bilirubin reduced from 418 to 119 µmol/L, bile acids to from 174 to 58 µmol/L and ammonia reduced from 172 to 55 µmol/L
His liver function showed gradual improvement following therapy initiation. Of note, one day after commencing combined CRRT+CytoSorb he was started on penicillamine based on the provisional diagnosis of Wilson’s Disease
His conscious level also improved and returned to his baseline level 2 days after CRRT+CytoSorb initiation
The coagulation profile improved and there was reduced requirement for FFP infusion
Except for mild, non-symptomatic thrombocytopenia and mild electrolyte disturbances, the therapy was well tolerated with no major complications encountered
Patient Follow-up
One dose of carglumic acid and regular sodium benzoate were started as a bridging therapy to prevent rebound of hyperammonemia upon CRRT termination
Sodium benzoate administration was stopped one week after CRRT termination
A drug challenge test was arranged and blood tests on day 20 of PICU admission showed serum levels of ammonia 37 µmol/L, total bilirubin 102 µmol/L, ALT 91 IU/L, ALP 170 IU/L, AST 43 IU/L, GGT 208 IU/L, INR was 0.95
He was finally discharged from the PICU 20 days after admission
Conclusion
In summary, this case demonstrates that hemoadsorption with CytoSorb can be safely employed as an adjunctive extracorporeal liver support modality in children with acute liver failure as it can efficiently remove bilirubin and bile acids
The authors state that hemoadsorption may have the advantages of a faster initial rate of bilirubin removal and ease of set up compared to albumin dialysis
The potential role of applying such technique in pediatric patients requires further evaluation in future studies.
Management of perioperative bleeding risk in patients on antithrombotic medications undergoing cardiac surgery – a systematic review
Matejic-Spasic M, Hassan K, Thielmann M, Geidel S, Storey RF, Schmoeckel M, Adamson H, Deliargyris EN, Wendt D. J Thorac Disease 2022; epub
08/2022
The aim of this review was to evaluate perioperative bleeding complications in patients on dual antiplatelet therapy (DAPT) or direct-acting oral anticoagulants (DOACs) undergoing high-bleeding risk cardiovascular surgery and to present currently available potential solutions to mitigate antithrombotic therapy-related bleeding complications. Relevant articles on bleeding complications in cardiac surgery from last 10 years in Medline (PubMed) were screened. An additional search evaluating potential solutions to mitigate bleeding complications was also performed. From all reviewed studies, a total of 19 articles could be included evaluating the risk for bleeding in cardiac surgery related to DAPT or DOACs, and 10 papers evaluating antithrombotic drug reversal or removal in this setting. Reported bleeding rates ranged between 18% and 41%, a remarkably wide variability. New costly reversal agents are available but have not been sufficiently tested in this setting. Antithrombotic removal by innovative intraoperative hemoadsorption has been shown to be associated with a significant decrease in re-thoracotomy rate, overall procedure duration, administered transfusion volumes, chest-tube drainage, and length of hospitalization. Results from ongoing trials should provide more informed insights concerning the efficacy and safety of several potential solutions.
Looks like they gave themselves shares, of course due to the fabulous job they've done, and the cowards release the info on a Friday night as well.
You didn't answer the question or respond to any of the points I brought up. Just wondering if you listened to the call or not and what your thoughts were concerning the points that were discussed in this call?
"There is too a Great Pumpkin. You'll see!"
Did anyone actually listen to the 2nd quarter earnings report. I think the reasons given for the reduced quarterly earnings were very much out of management hands and should be improving greatly over the next quarter or two. Also, there is a marked increase in the number of publications showing positive results that are being put out with quite a few more being published in the coming months. In addition, the START-T & START-D Trials should really be ramping up over the next quarter since both have over 20 sites now recruiting with a lot of synergies between the two studies.
I know it's been a long time coming but I can certainly wait another quarter or two before I start badmouthing management. I'd like to see some other comments concerning this call and get other people's opinion.
Case of the Week
Literature Database
Hemoadsorption for severe MIS-C in critically ill children, should we consider it as a therapeutic opportunity?
Gabriella Bottari1, Flavia Severini2, Anna Hermine Markowich2, Giulia Lorenzetti2, Juan Carlos Ruiz Rodriguez3,4, Ricard Ferrer3,4, Paola Francalanci5, Antonio Ammirati6, Paolo Palma7 and Corrado Cecchetti1 |1 Pediatric Intensive Care Unit, Pediatric Emergency Department, Bambino Gesù Children’s Hospital, IRCCS, Rome, Italy | 2 Department of Pediatrics, University of Rome Tor Vergata, Residency School of Pediatrics, Bambino Gesù Children’s Hospital, IRCCS, Rome, Italy | 3 Intensive Care Department, Vall d’Hebron University Hospital, Vall d’Hebron Barcelona Hospital Campus, Barcelona, Spain | 4 Shock, Organ Dysfunction and Resuscitation Research Group, Vall d’Hebron Research, Institute (VHIR), Barcelona, Spain | 5 Unit of Pathology, Bambino Gesù Children’s Hospital, IRCCS, Rome, Italy | 6 Pediatric Emergency Unit, Pediatric Emergency Department, Bambino Gesù Children’s Hospital, IRCSS, Rome, Italy Int J Artif Organs 2022; epub
08/10/2022
New!PediatricsPeer Reviewed Published DataReduction in catecholaminesReviewSafetyViral infectionCase of the weekCase reportCOVID-19Critical CareCRRT (pre or post filter)Inflammatory parameters
Download documentDownload documentLink to source
Summary
CoW 32/2022 – This case reports on a 13 year old boy (weight 60 kg, height 160 cm) who presented with fever, rash, abdominal pain, and vomiting.
Summary
Multisystem inflammatory syndrome (MIS-C) is a new severe clinical condition that has emerged during the COVID-19 pandemic and affects children and the young usually after a mild or asymptomatic COVID-19 infection. Symptoms commonly include cardiovascular dysfunction for which support is required in the majority of cases. In the case report a 13 yr old boy with refractory shock secondary to left ventricular dysfunction (LVD) in the context of MIS-C, the use of hemoadsorption with CytoSorb is described. The therapeutic strategy resulted in hemodynamic and clinical stabilization (reduction then cessation of vasopressors) as well as control of the hyperinflammatory response (including C-Reactive Protein, interleukin – IL-6 and IL-10). The patient received in total 5 adsorbers over 72 hrs. with the first 2 adsorbers for 12 hours each, and a further 3 adsorbers for 24 hours each inserted into the continuous renal replacement circuit. Treatment appeared to be safe and feasible. The authors then compare this case with two more published cases where CytoSorb has been used as an adjuvant therapy in similarly critically ill children with severe forms of MIS-C. All three patients responded with a prompt improvement in their myocardial function (within the first 24 h) following the start of hemadsorption. The authors state that using this blood purification strategy could be a therapeutic opportunity in severe LVD due to MIS-C, sparing the need for extracorporeal membrane oxygenation (ECMO) and other mechanical cardiocirculatory supports, with the advantage of it being less invasive. They also state that CytoSorb does not appear to interfere with most common immunomodulatory therapies although further evidence is required.
Case presentation
Blood tests revealed elevated leukocytes with neutrophilia, high C-reactive protein (CRP) (29.31 mg/gL), procalcitonin (3.32 ng/mL), and hyperferritinemia (1529 ng/mL)
He had a positive history for SARS-CoV-2 infection 6 weeks previously with positive serology
Within 24 h he developed diarrhea, poor pallor, and hypotension
Cardiac markers were elevated, and 2D-echocardiogram showed left ventricular (LV) dysfunction (Ejection Fraction EF 35%)
Supportive care with milrinone and dopamine was started and, as multisystem inflammatory syndrome in children (MIS-C) was suspected, he received immunoglobulins and corticosteroids
The following day he deteriorated, with an 2D-echocardiogram showing a LVEF of 25%, therefore he was referred to the pediatric intensive care unit (PICU) requiring endotracheal intubation and invasive mechanical ventilation (IMV) due to cardiogenic shock
Given the increase in troponin I (high sensitivity troponin, hs-TnI) levels from 75 to 1200 pg/ml in 12 h, infectious myocarditis was suspected and an endomyocardial biopsy (EMB) was taken
Considering the clinical picture of hyperinflammation associated severe shock due to left ventricular dysfunction (LVD) and high lactate (7.9 mmol/l) with the need for high inotropic and vasopressor support (epinephrine 0.35 µ/kg/min, norepinephrine 0.06 µ/kg/min, and milrinone 0.5 µ/kg/min), hemoadsorption with CytoSorb was started in combination with continuous kidney replacement therapy (CKRT)
Of note, even though the patient fulfilled the diagnostic criteria of MIS-C, the authors could not completely rule out the development of fulminant myocarditis due to Parvovirus B19 (PVB19) positivity after suffering from COVID-19, which is why corticosteroids were withheld and immunoglobulins and anakinra were maintained
Treatment
The patient received in total 5 adsorbers over 72 hrs with the first 2 adsorbers for 12 hours each, and a further 3 adsorbers for 24 hours each inserted into the continuous renal replacement circuit
Anticoagulation protocol: citrate-calcium
Measurements
Hemodynamics and requirements for vasoactive substances
Inflammatory parameters
Left ventricular ejection fraction
Cardiac enzymes
Safety
Results
The therapeutic strategy resulted in hemodynamic stabilization with a rapid reduction followed by the cessation of vasopressors at the time of discontinuation of CytoSorb therapy
Treatment was also associated with control of the hyperinflammatory response as evidenced by a reduction in inflammatory parameters including CRP, interleukin – IL-6 and IL-10
After the first 24 h of combined hemoadsorption and CKRT therapy, an improvement in the LVEF to 50% was observed
Troponin I levels decreased from 1200 pg/ml to around 375 pg/ml within 12 hours of treatment with decreasing levels thereafter, reaching ~100 pg/ml by the end of blood purification therapy
No adverse events were noted
Patient Follow-up
CKRT was discontinued at the same time of hemoperfusion after 72 h (day 3)
He was weaned off invasive mechanical ventilation on day 6 and discharged from the PICU on day 8
After 2 weeks his cardiac function had completely restored and the patient was discharged from the hospital on day 20 requiring only the diuretic, spironolactone
Conclusion
In this adolescent with refractory shock secondary to LV dysfunction in the context of MIS-C, treatment with hemoadsorption in combination with immunomodulatory therapies resulted in hemodynamic and clinical stabilization as well as control of the hyperinflammatory response with the treatment appearing safe and feasible
The authors compare this case with two more published cases where CytoSorb has been used as an adjuvant therapy in similarly critically ill children with severe forms of MIS-C. All three patients responded with prompt improvements in their myocardial function (within the first 24 h) following the start of hemoadsorption
The authors state that using this blood purification strategy could be a therapeutic opportunity in severe LVD due to MIS-C, sparing the need for extracorporeal membrane oxygenation (ECMO) and other mechanical cardiocirculatory supports, with the advantage of it being less invasive. They also state that CytoSorb does not appear to interfere with most common immunomodulatory therapies although further evidence is required.
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I think I said it perfectly on this reply to a 2019 post I made here, it was spot on!
The warning signs have been here for years, the hit piece was absolutely correct, .075 presplit, sad, no future catalyst only bankruptcy eventually!
I've really tried to stay quiet but THEY SUCK. Inept, overmatched, incompetent. Disgraceful. When does somebody pay with their job? WHEN???
Extracorporeal hemoadsorption with the CytoSorb device as a potential therapeutic option in severe intoxications: Review of the rationale and current clinical experiences
Darko Mitrovic et al. J Clin Pharm Ther. 2022.
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J Clin Pharm Ther
. 2022 Aug 3.
doi: 10.1111/jcpt.13724. Online ahead of print.
Authors
Darko Mitrovic 1 , Daan W Huntjens 2 , Elisabeth A J de Vos 3 , Martijn van Tellingen 4 , Eric J F Franssen 2
Affiliations
1 Hospital Pharmacy, Tjongerschans Hospital Heerenveen, Heerenveen, The Netherlands.
2 Department of Clinical Pharmacy, OLVG Hospital, Amsterdam, The Netherlands.
3 Department of Intensive Care, OLVG Hospital, Amsterdam, The Netherlands.
4 Intensive Care, Tjongerschans Hospital Heerenveen, Heerenveen, The Netherlands.
PMID: 35924306
DOI: 10.1111/jcpt.13724
Cite
Abstract
What is known and objective: Many severe intoxications occur with substances with no specific antidote, which is why methods of extracorporeal elimination represent a particularly useful and even critical component in their management. The purpose of this review is to summarize the accumulating evidence and clinical results from the application of CytoSorb hemoadsorption therapy in patients with severe intoxications.
Comment: The technology represents a promising technique with an increasing number of publications in a variety of severe intoxication scenarios suggesting that early intervention might provide rapid substance removal with subsequent overall clinical improvement.
What is new and conclusion: Given the tremendous challenges in performing prospective, randomized trials in this field, the strong safety profile of the device and the high acuity of these life-threatening situations, CytoSorb should be considered as a therapeutic option in severe intoxications, particularly when direct antidotes are not available. However, further clinical data are desirable to provide precise recommendations.
Keywords: CytoSorb; blood purification; drug; hemoadsorption; intoxication.
Case of the Week
Literature Database
First Hemoadsorption during Cardiopulmonary Bypass in Neonate with Complex Cardiac Malformation
Christophel-Plathier E, Mendes V, Verdy F, Mauron S, Mury C. Annals of Clinical Case Reports 2022; 7:2257
08/03/2022
New!PediatricsPeer Reviewed Published DataReduction in catecholaminesReduction in length of staySafetyImprov. resp functionImpact on organ supportCardiac surgeryCase of the weekCase reportCPBInflammatory parametersIntra-Op
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Summary
CoW 31/2022 – This case reports on a 5 day old male full term newborn with congenital hypoplastic left heart syndrome who was scheduled for a corrective procedure.
Case presentation
His left heart syndrome involved an absent mitral valve and exceedingly small aortic annulus, ascending aorta and aortic arch. Perfusion of the aortic arch was retrograde through a persistent patent ductus arteriosus. Right ventricular systolic function was normal
Shortly after birth, the neonate required continuous positive airway pressure (CPAP) and then invasive ventilation with permissive hypercapnia
He received levosimendan 12 h before surgery, and maintenance with a prostaglandin E1 infusion
Five days after birth, the patient underwent a Norwood stage I palliation with interatrial septum resection, aortic arch reconstruction and the creation of a Blalock-Taussig shunt
Cardiopulmonary bypass (CPB) duration was 227 min, aortic cross-clamping duration 180 min. Selective cerebral perfusion was 27 min at a central core temperature of 27.8° Celsius
In order to reduce the pre-operative and intra-operative inflammatory process, a CytoSorb hemoadsorption device was pre-emptively integrated into the CPB circuit
Treatment
The CytoSorb cartridge was inserted between the oxygenator outlet (QUADROX-i neonatal HMO 11000® MAQUET) and the venous line, assisted by a roller pump slave to the blood pump
The minimum flow rate through the cartridge was 100 ml/min. The servo control was 14% of the patient’s theoretical flow, indexed to 3.0 l/min/m2 to compensate for the drop induced by CytoSorb and to ensure a flow rate of 2.4 l/min/m2 to the patient
Priming was performed using “ventilated reconstituted whole blood” to ensure homeostatic conditions at CPB initiation requiring 385 ml of blood, of which 120 ml were used for priming the CytoSorb
Measurements
Hemodynamics and requirements for vasoactive substances
Overall clinical course
Results
The patient returned to the intensive care unit (ICU) intubated with infusions of norepinephrine, dopamine and milrinone. Thereafter, hemodynamic adaptation was good, with rapid weaning off all amine infusions and definitive weaning off norepinephrine on post-operative day 5
Surgery was successful and correction was adequate, with unobstructed flow through the interatrial communication and inside the aortic arch, and with good ventricular function. Despite the severity of his condition, the baby had anuneventful post-operative course, without renal, digestive, or infectious complications
Patient Follow-up
The patient was extubated on post-operative day 6
He left the ICU on day 22 and was discharged home on day 45
Conclusion
The authors describe the clinical course post-operatively as remarkable with shortened ICU and hospital lengths of stay due to the lack of (anticipated) complications. They state that previous similar cases have required much longer support on ventilation and longer ICU stays. They also believe the expected benefits to the anti-inflammatory processes are worth the large homologous blood use
As the use of CytoSorb was the only differentiating factor, its use likely helped to reduce the pre-operative and intra-operative inflammatory process, and thereby helped with the positive clinical course and outcome. The authors conclude with stating that by reducing cytokine levels, CytoSorb may have significantly reduced catecholamine infusion time, intubation time, and ICU stay.
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