Report

Teaser, summary, work performed and final results

Periodic Reporting for period 2 - CIRDinnova (Shifting the limits of resuscitation with “CIRD Controlled Integrated Resuscitation Device”)

Teaser

Sudden cardiac arrest is worldwide one of the most frequent causes of death. Therapeutic state of the art is CPR (Cardiopulmonary Resuscitation) i.e. chest compression, breathing, defibrillation etc. In Europe between 400,000 and 500,000 CPRs are performed annually, but the...

Summary

Sudden cardiac arrest is worldwide one of the most frequent causes of death. Therapeutic state of the art is CPR (Cardiopulmonary Resuscitation) i.e. chest compression, breathing, defibrillation etc. In Europe between 400,000 and 500,000 CPRs are performed annually, but the clinical outcome is dramatically poor: Only 3% of the patients survive out-of-hospital resuscitation, and only 18% survive in-hospital resuscitation - most of them with severe neurological damage! For decades no significant improvement of the clinical outcome and no significant scientific progress in resuscitation could be shown! One main reason for this unsatisfying situation is the very short time-frame in which successful resuscitation using CPR has to be performed – only 5 minutes after cardiac arrest. Thereafter, with every minute a rapid decline in survival is observed, tending to “zero” beyond 10 minutes of CPR. Second important cause for the poor outcome is the formation of detrimental metabolic products in the tissue and in the blood caused by the lack of oxygen. A sudden replenishment of nutrients in an uncontrolled fashion (“reperfusion”) enhances deleterious cellular processes called “reperfusion injury”. Avoiding or minimizing the reperfusion injury is a main challenge for improving clinical outcome. The new therapeutic concept “Controlled Automated Reperfusion of the whole body” CARL goes far beyond present ECPR therapy showing that the clinical outcome can be improved significantly using a special technology – the CARL system developed by Resuscitec.

The overall rationale of the CARL therapy is to minimize reperfusion injury combined with a replenishment of substrates and energy in the cells in order to support the consequent repair processes. This therapeutic strategy is based on two main features: (a) the adaption of the chemical composition of the reperfusion solution by pharmaceuticals, and (b) the control of the physical conditions of reperfusion i.e. flow, pressure, temperature etc. Core of the therapeutic approach is the measurement of a set of biomarkers in a real-time fashion in order to take immediate therapeutic measures by administering of pharmaceuticals. The fast controlled and automated adaption of the chemical and physical parameters during the treatment is a completely new approach in the field of cardiopulmonary resuscitation.

This unique combination of innovative therapy and medical device represents a highly promising market opportunity: the CARL therapy can only be performed with the CARL System which can only be delivered by Resuscitec. The CARL system is a specific device for the extra-corporeal circulation of blood (a special kind of heart-lung-machine) specifically designed to apply the new CARL therapy. As most of the resuscitations take place out of hospital has been designed as a mobile system which can be transported to any place where patients suffer from a cardiac arrest.

The CARL technology is protected by patents in the ownership of Resuscitec. The overall objective of the innovation action which brings together three clinical partners with the manufacturer of the CARL system device is to achieve market readiness with respect to all relevant aspects and conditions to realise a fast and economic successful market entry and uptake beginning in the year 2021 and to show European leadership in the field of emergency medicine and resuscitation devices. That means especially to achieve clinical market readiness beyond the regulatory market approval in a real world system validation to show extended clinical evidence, safety and efficacy of CARL. Besides this it will be essential to achieve user qualification readiness by developing tools and training programmes for users and proctors for a safe, sustainable and successful deployment and dissemination of CARL.

Work performed

To achieve market readiness the work programme meet 7 challenges: (1) Clinical market readiness, (2) User qualification readiness, (3) User support readiness, (4) Guideline readiness of the therapy, (5) Legal and regulatory market readiness, (6) Economic market readiness, (7) Market communication and dissemination readiness.

Final results

The CARL-System device is the first device worldwide which enables the user – based on the new personalised therapeutic concept CARL - to resuscitate patients successfully out-of-hospital and in-hospital far beyond the timeframe of up to 10 minutes after cardiac arrest which is the limiting standard today. For the first time in the history of resuscitation medicine the poor clinical outcome of only 3% survivors out-of-hospital and only 18% survivors in-hospital will significantly be improved, not only in percentage of surviving patients but also concerning the quality of life for the surviving patients. Significantly more people will survive cardiac arrest, and the quality of survival will be much better as today. This will also lead to significant cost savings in the health systems. This is game changing in a field of medicine where no improvement of clinical outcomes happened for decades, but which is a true societal challenge as cardiac arrest is one of the most frequent causes of death.

Website & more info

More info: http://www.resuscitec.de/index_en.html.