NIH-Funded Study is First to Demonstrate Increased Long-Term Survival with Favorable Neurologic Function Using ACSI Devices
Roseville, MN -- A combination of two devices could save the lives of thousands of cardiac arrest patients each year if implemented nationwide, suggests clinical trial results published in today’s online edition of The Lancet. A significantly higher percentage of patients who experienced out-of-hospital cardiac arrest survived after receiving active compression decompression cardiopulmonary resuscitation (ACD CPR) performed with the ResQPump®, and the ResQPOD® impedance threshold device, as compared to those receiving conventional, manual CPR performed with a pair of hands. Both devices are manufactured by Advanced Circulatory Systems, Inc. (ACSI) in Roseville, Minn.
Dr. Tom P. Aufderheide, Professor of Emergency Medicine at the Medical College of Wisconsin in Milwaukee (Wisconsin) was first author and a principal investigator at one of the study sites. “The goal of resuscitation during cardiac arrest is long-term survival with preservation of brain function,” commented Dr. Aufderheide. “This new, effective intervention achieves that goal and is potentially the most significant advancement in the treatment of cardiac arrest since defibrillation.” Ralph J. Frascone, MD, Associate Professor of Emergency Medicine at the University of Minnesota and emergency medical services (EMS) medical director at Regions Hospital in St. Paul (Minnesota) commented further. "Each year, approximately 300,000 Americans experience out-of-hospital cardiac arrest, and the national average for survival to hospital discharge is dismal – only about 5 percent," Dr. Frascone said. "However, in this study, patients who received CPR by rescuers using the device combination had a 53 percent higher survival to hospital discharge rate with favorable neurologic function than those who did not, and, a significant survival benefit was still present one year after the initial cardiac arrest event."
Funded by the National Institutes of Health and sponsored by Advanced Circulatory Systems, Inc., the trial compared survival rates among a control group of 813 cardiac arrest patients receiving standard CPR, to an intervention group of 840 patients receiving ACD CPR, performed using the ResQPump, with an impedance threshold device (ITD), the ResQPOD. All other aspects of patient care, such as airway management, IV fluids, medications, defibrillation, resuscitation length, etc., were similar between the two groups. The randomized, prospective, multi-center trial was performed in seven distinct United States (US) geographic locations, including 46 EMS agencies in urban, suburban, and rural areas serving a total population of 2.3 million. The study showed that CPR using these devices was easy to teach and implement in multiple EMS systems across the country. In patients with cardiac arrest, time to CPR treatment is critical for survival. In all study patients, EMS CPR was provided within approximately 6 minutes after receiving the 911 call. Importantly, CPR using the study devices was begun within 7 minutes and resulted in not only significantly increased survival, but preserved neurologic function as well. Keith G. Lurie, MD, chief medical officer of Advanced Circulatory Systems, stated "This was a huge undertaking, involving thousands of EMS providers and hospital personnel over a span of about five years. It is also the first prospective, 49-0810-000, 02 randomized clinical trial to demonstrate a long-term survival benefit with favorable neurologic benefit using CPR devices."
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 selectively 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, active compression decompression (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.
Advanced Circulatory Systems, Inc. is a privately held manufacturer of advanced circulatory technology based in Roseville, Minnesota. Its mission is to restore life and improve the quality of life for patients experiencing cardiac arrest, low blood pressure and head injury by developing new technologies to non-invasively increase circulation throughout the body, improving opportunities for survival and quality of life. The company manufactures and markets the ResQPOD, a version of which is currently available for sale and in use at more than 1,200 hospitals and EMS systems throughout the US, and the CardioPump, which is currently available for sale only outside the US.