ZOLL Medical Corporation (Nasdaq GS: ZOLL), a manufacturer of medical devices and related software solutions, announced today that results from the CIRC trial were presented at the American Heart Association (AHA) 2011 Resuscitation Science Symposium (ReSS) this weekend in Orlando. The CIRC trial compared the rates of survival to hospital discharge from out-of-hospital cardiac arrest of patients treated with a load-distributing band device (AutoPulse® Non-invasive Cardiac Support Pump) to those receiving manual CPR. The trial confirmed the impact that high-quality cardiopulmonary resuscitation (CPR) can have on improving survival rates from sudden cardiac arrest (SCA). The trial also concluded that AutoPulse compressions were equivalent to high-quality manual compressions.
“It was important to ensure that the quality of compressions in the manual control arm was high”
The trial commenced in 2007 and enrolled 4,231 patients. The principal investigator for the trial was Lars Wik, M.D., Ph.D., Oslo University Hospital, Oslo, Norway. The trial was an international effort with trial sites in the United States, Austria, and The Netherlands. More than 500 ZOLL AutoPulse units were deployed and more than 5,000 medics were trained on the use of the device.
One of the unique facets of the trial's design was a focus on the delivery of high-quality manual CPR. Investigators closely tracked CPR fraction, the percentage of time that compressions are being delivered during the resuscitations, as a marker of CPR quality. The CPR fractions reported in both arms of the trial were very high for a large, multicenter prospectively randomized study. The resulting overall survival rate in the CIRC trial was also comparatively higher.
"The CIRC trial confirms the link between high-quality CPR and survival from cardiac arrest," said Richard A. Packer, CEO of ZOLL. "It tells us EMS services must employ a strategy to improve CPR. The AutoPulse provides a proven alternative to the significant incremental investments in training, personnel, and processes required to achieve the quality of manual CPR delivered during the trial."
The high-quality CPR reported resulted from a rigorous study design previously reported in the Journal of Resuscitation during 2010. The protocol incorporated an intensive training program that was uniformly delivered to caregivers at all participating sites. It focused on minimizing hands-off time, and was built on foundation of frequent re-training.
"It was important to ensure that the quality of compressions in the manual control arm was high," said Dr. Wik. "Comparing load-distributing band CPR against manual compressions of a poor or unknown quality would undermine the integrity and clinical usefulness of the findings."
"The significance of the CIRC trial goes beyond the promise of these findings," Packer said. "Its methodology points to how pre-hospital research should be conducted from this point forward. In light of the impact of CPR quality on survival, it would suggest it might be shortsighted to evaluate the impact of any resuscitation intervention in the absence of understanding the quality of compressions delivered."
Manual CPR is the standard for providing temporary circulatory support and oxygen delivery during cardiac arrest and has the highest treatment recommendation (Class I) in the American Heart Association Guidelines. However, delivery of manual CPR is often inconsistent. Significant decreases in quality have been seen after as little as one minute. The physical challenges associated with providing consistent manual CPR are recognized as a key factor limiting CPR quality. Mechanical chest compression devices have been developed to overcome the difficulties in consistent performance of manual CPR.
Out-of-hospital SCA is a substantial public health problem killing approximately 325,000 persons each year in the U.S. and Canada alone, and as many as a million worldwide. Mortality in most communities exceeds 90 percent, although improvements in resuscitation practices could potentially save as many as half of these victims.
Public defibrillators rarely used during cardiac arrest incidents, research shows