Groundbreaking Randomized Controlled Trial Reports Excellent Clinical Outcomes Using CytoSorb Intraoperatively in Heart Transplant Patients

CytoSorb Blood Purification Results in Statistically Significant Reductions in Multiple Organ Failure and Dysfunction

PRINCETON, N.J., Jan. 17, 2024 (GLOBE NEWSWIRE) -- 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, reports on excellent outcomes from a groundbreaking randomized controlled trial (RCT) using CytoSorb blood purification during heart transplant, recently published in the European Society of Cardiology journal, ESC Heart Failure.

As co-lead authors Drs. Endre Németh and Adam Soltesz from the Heart and Vascular Center at Semmelweis University, Budapest, Hungary explain, as more complex and higher risk patients become eligible for heart transplant, so does the risk of serious complications such as multiple organ failure, that not only is the second leading cause of death following heart transplant, but results in high costs due to protracted ICU and hospital stays. In particular, vasoplegic syndrome (VS), a form of circulatory failure or shock, is routinely seen in these patients and can cause worsened organ failure. In a prior observational study, CytoSorb was associated with the reduced severity of vasoplegia in heart transplant patients, in addition to other clinical benefits.

In this prospective, single-center, open-label RCT, 60 heart transplant recipients were randomly assigned to either receive intraoperative CytoSorb hemoadsorption or standard of care. Key statistically significant findings of the study were that the CytoSorb group, compared to the control group, had:

1. Better hemodynamic stability and lower rates of post-operative shock
   • Patients in the CytoSorb group had lower median Vasoactive-Inotropic Scores (27.2 [14.6–47.7] vs. 41.9 [22.4–63.2], p=0.046) and Vasoplegic Syndrome rates (20.0% vs 48.0% control, p=0.028)
   • The odds of early Vasoplegic Syndrome were 6.4 times lower in the CytoSorb group (p=0.029).
2. Shorter median time on mechanical ventilation
   • 25 [19–68.8] hours vs. 65 [23–287] hours in control, p=0.025
3. Lower rates of acute kidney injury (AKI) and need for renal replacement therapy (RRT)
   • AKI: 36.7% vs. 76.0% control, p=0.004
   • Renal replacement therapy: 0% vs. 16.0% control, p=0.037
4. Shorter median time in the ICU
   • 8.5 [8.0–10.3] days vs. 12 [8.5–18.0] days in control, p=0.022
5. No relevant removal of the anti-rejection drug mycophenolic acid (MPA)
6. Similar rates of cardiac allograft rejection, 30-day mortality, and 1-year survival between groups
7. There were no reported device-related adverse events during the study period