The investigator-initiated clinical study titled "Hyperinvasive Approach in Refractory Out-of-hospital Cardiac Arrest (OHCA): An Open-label Randomized Controlled Trial. Prague OHCA Study" was presented virtually during the American College of Cardiology 2021 Scientific Session, on Monday, May 17 by Jan Bělohlávek, MD, PhD, professor of medicine at Charles University in Prague, Czech Republic, and lead author of the study.
The hyperinvasive approach features early transport to hospital under mechanical CPR, intra arrest nasal cooling, extracorporeal CPR (venoarterial extracorporeal membrane oxygenation [VA ECMO]), and immediate invasive evaluatation of the patient. However, the bundle of different technologies and methods in the complex study design, makes it difficult to draw independent conclusions of different methods and technologies. Recent clinical evidence on the use of a mechanical CPR (LUCAS) in out-of-hospital cardiac arrest suggests that it should not be used routinely because it has no superior effects and could be potentially harmful, with an impact on survival. https://pubmed.ncbi.nlm.nih.gov/32771318/. Yet, on the other hand, the PRINCESS (Pre-hospital Resuscitation Intra arrest Cooling) trial showed that the intra-arrest therapeutic hypothermia, initiated in the field with trans nasal evaporative cooling (RhinoChill[®]), compared to standard ACLS (Advanced cardiovascular life support) would provide benefits in survival with good neurologic outcome in patients with out-of-hospital cardiac arrest, particularly if it applied less than 20 minutes after arrest.
While the primary endpoint of the study was not met, several interesting findings were revealed. First, neurologic recovery at 30 days was higher in the hyperinvasive arm at 30.6% vs. 18.2% (p=0.02). Second, survival at 6 months was numerically higher in the hyperinvasive arm, trending toward significance. Finally, in a subgroup analysis of patients receiving ACLS for more than 45 minutes, there was a clear benefit in the hyperinvasive arm, where 20 patients survived, compared to six in the standard arm, four of whom were crossed over to receive ECMO anyway. This finding, in addition to the improvement in neurologic outcomes seen in the hyperinvasive arm, prompted the Data Safety Monitoring Board to terminate the study early for ethical reasons (improves survival and neurological improved recovery in subset of patients).
The study involved 256 patients that were randomly assigned to receive either standard advanced cardiac life support or hyperinvasive support. Patients in the standard-care group were treated at the site where the OHCA occurred with manual CPR, defibrillation, medications to reverse the cardiac arrest. Patients in the hyperinvasive group received mechanical CPR using a device that provided automatic chest compression and were transported immediately to a cardiac center while receiving intra-arrest therapeutic hypothermia by RhinoChill[®] device. If their heartbeat was not restarted on route, they were placed on an extracorporeal membrane oxygenation (ECMO) machine. This machine temporarily takes over the work of the heart and lungs by infusing fresh oxygen into the blood and pumping blood to the body's organs and tissues.
CEO Martin Waleij comments
This important scientific clinical study, expected lead to several publications clearly shows that the optimal prehospital care, includes the ability to have a bystander perform chest compressions at the scene of the arrest, and the ability to rapidly, safely and effectively cool the patient`s brain by Rhinochill[®]. Furthermore, quickly transporting the patient to a dedicated cardiac center and treatment with ECMO should be considered for patients whose hearts do not regain spontaneous activity with standard advanced cardiac life support. This is yet another evidence that time is the critical factor for post resuscitation care following cardiac arrest.
About the clinical study
The study was funded by the Ministry of Health of the Czech Republic. Cardiac arrest occurs when a sudden malfunction of the heart's electrical system causes the heart to begin beating very erratically, which interrupts blood flow to the heart and brain. According to the Centers for Disease Control and Prevention, about 375,000 people have an OHCA every year in the U.S. The survival rate after an OHCA is about 12%. To survive, the patient must receive immediate cardiopulmonary resuscitation (CPR) to increase blood flow to the heart and brain and an electrical shock from a defibrillator to stop the abnormal heart rhythm.
BrainCool continue their mission that all cardiac arrest patients should be cooled at the earliest opportunity in a hospital or at field emergency setting with the aim and objective to improve survival and neurological recovery.
Our solution that the BrainCell concept will target, is the problem with limitations of previous products in the treatments chain of cardiac arrest patients, as well as expanding the concept into neurology.
By the integration of RhinoChill[®] and BrainCool, BrainCell enables health-care personnel to easily and effectively and most importantly immediately initiate cooling of the brain immediately after the SCA (RhinoChill[®]). The BrainCell ensures long-term cooling during multiple days (BrainCool), completing the chain of treatment."