Emergency Cardiopulmonary Bypass for Cardiac Arrest

Overview

Cardiac arrest ist associated with a very poor prognosis. Even though resuscitation algorithms and postcardiac arrest care have been improved there is an urgent need for measures leading to a higher survival rate. Emergency cardiopulmonary bypass (ECPB - artificial heart and lung outside the patients body) is a method which has shown good results in case reports and animal studies for cardiac arrest care. The study will be performed as comparison between the new treatment option of ECPB versus the standard of care treatment. Aim of our study is to determine the feasibility of ECPB installed in an emergency department to improve the rate of patients restoration of spontaneous circulation.

Background: Out of hospital cardiac arrest is associated with a poor prognosis. Overall survival varies between 3% and 16% respectively. Measures to improve the chance of survival are urgently needed. If return of spontaneous circulation under competent cardiopulmonary resuscitation (CPR) measures is not achieved within the first 25 minutes the chance of survival decreases even further. Emergency Cardiopulmonary Bypass (ECPB) would be such a treatment option for these heavily compromised patients, as it has shown considerably good results used as resuscitation device for cardiac arrest in animal studies. Material and Methods: This study will be performed as single center (university hospital) randomized, controlled and prospective pilot study comprising a highly experienced emergency department treating about 200 to 300 cardiac arrest patients a year. Two groups will be analyzed, a 'Standard ACLS´ group and an 'ECPB´ group. Each group will comprise 20 patients. Eligible are adult patients with witnessed out of hospital cardiac arrest, with presumed cardiac cause and without return of spontaneous circulation after a minimum of 15 minutes of advanced cardiac life support. Patients in the 'Standard ACLS´ group will be resuscitated until return of spontaneous circulation or termination of efforts. The 'ECPB´ group will receive ongoing cardiopulmonary resuscitation during transport to the emergency department where ECPB will be installed. Necessary diagnostic examinations and therapeutic interventions for both groups will be performed according to guidelines for post resuscitation care and good clinical practice. Primary outcome measure is the rate of sustained restoration of spontaneous circulation according to Utstein criteria. Secondary outcome measures are 24 hours survival, survival to ICU discharge, survival to hospital discharge, rate of best neurological recovery (cerebral performance category score 1 or 2) within 6 months after cardiac arrest and modified Rankin score at 6 months after cardiac arrest. Patients in the 'Standard ACLS´ group receive standard treatment without any potential additional risks. The 'ECPB´ group receives standard advanced cardiac life support as well and has the predicted advantage of the extracorporeal oxygenation at the emergency department and coronary intervention even before return of spontaneous circulation. Aim of this study: To compare current standard therapy for patients after out of hospital cardiac arrest (cardiopulmonary resuscitation until return of spontaneous circulation or termination of efforts) with a new concept of transportation with ongoing cardiopulmonary reanimation and installation of ECPB at the Emergency Department to improve survival.