ROSEVILLE, Minn.-- Today, Advanced Circulatory Systems Inc. (ACSI) announced results from a large, NIH-funded clinical trial comparing standard cardiopulmonary resuscitation (CPR) to a new method of CPR that provides greater protection to the heart and brain when the heart stops beating (cardiac arrest). Their new device combination, called the ResQCPR™ System, combines an active compression decompression CPR (ACD-CPR) device, called the ResQPump™, and an impedance threshold device (ITD), called the ResQPOD®.
Additional results from the ResQTrial study have now demonstrated that when the ResQCPR System was used together with therapeutic hypothermia, there was a six-fold increase in the percentage of patients who improved from poor neurologic function at hospital discharge to good neurologic function at 90 days, when compared to standard CPR with hypothermia.
"The striking improvement in patients treated with the ResQCPR System and hypothermia demonstrates the important synergy between the two technologies. These findings provide a new way to significantly decrease the number of patients with poor long-term neurological function, especially when the ResQCPR System is applied early during cardiac arrest," Said Dr. Marvin Wayne, EMS Medical Director of Whatcom County in Washington, and principal author of the study.
The ResQTrial Study evaluated over 5,000 patients in seven different US emergency medical services (EMS) systems to determine the effect of the ResQCPR System on rates of long-term survival with good brain function. The new findings from the study focus on the subset of patients with poor brain function (neurologic outcomes) at the time of hospital discharge. Poor neurological function for survivors after cardiac arrest is an enormous burden for families, patients, and society due to the high health care costs associated with caring for them. About 25 percent of the survivors treated with either standard CPR or the ResQCPR System had poor neurological function at the time of hospital discharge.
Dr. Marvin Wayne and colleagues compared long-term neurologic outcomes for those survivors who were treated in one of four ways: 1) standard CPR with no therapeutic hypothermia, 2) standard CPR with therapeutic hypothermia, 3) the ResQCPR System with no therapeutic hypothermia, or 4) the ResQCPR System with therapeutic hypothermia. Therapeutic hypothermia, which cools patients after cardiac arrest, is often used to help improve outcomes after cardiac arrest.
ACSI previously demonstrated in laboratory studies that the ResQCPR System triples blood flow to the heart and brain when applied early in the treatment of cardiac arrest. Primary results from the ResQTrial, published earlier this year in The Lancet, demonstrated that use of the ResQPOD and ResQPump combination resulted in a greater than 50 percent increase in the number of patients who survived to hospital discharge with favorable neurological function compared with those treated with standard CPR. The 50% survival benefit was observed up to a year after cardiac arrest.
These new results from the ResQTrial Study will be presented at the American Heart Association in November 2011. ACSI has applied to the FDA to obtain approval of the ResQCPR System in the United States and hopes it will be widely available for patient care in the near future.
The ResQPOD® is an impedance threshold device (ITD) that selectively prevents unnecessary respiratory gases from entering the chest during the chest wall recoil phase of CPR. It is attached within the ventilation circuit between the airway device and the ventilation source. By therapeutically restricting airflow during CPR, the device creates a small but important negative pressure (vacuum) in the chest that has been shown in numerous human and animal clinical trials to increase blood flow back to the patient's heart during CPR.
The ResQPump™ is a hand-held, ACD-CPR device placed in the same position on the sternum as the hands and enabling rescuers to perform similar chest compressions as in conventional CPR. Instead of allowing the chest wall to recoil passively, however, rescuers pull up on the ResQPump's handle with its suction cup. This provides active decompression of the chest, promotes optimal chest wall recoil and creates a negative intrathoracic pressure (vacuum) that helps return blood to the heart. The handle contains a force gauge and metronome that guide compression depth, recoil and rate. The ResQPump is identical to the CardioPump®, an ACD CPR device available for sale outside the US.
SOURCE: Advanced Circulatory Systems, Inc.