A pair of studies appearing in the June 14 issue of the Journal of the American Medical Association yielded mixed results for the AutoPulse Noninvasive Cardiac Support Pump.
The first involved the multi-center ASPIRE (Assisted Prehospital International Resuscitation Research) trial. Among its primary study population, the trial showed that survival at four hours was essentially the same between victims of sudden cardiac arrest who received CPR with the AutoPulse--a portable device that automates and standardizes chest compressions by way of a load-distributing band across the chest--and those who received manual CPR (26.4% and 24.7%, respectively), but that survival to hospital discharge was higher among the manual-CPR group (9.9% vs. 5.8%). In addition, investigators found that the AutoPulse group showed worse neurological outcomes, which prompted them to end study enrollment early.
The second study, which tracked use by the Richmond (VA) Ambulance Authority, showed dramatically different results. It found that AutoPulse patients showed higher rates of return of spontaneous circulation (34.5% vs. 20.2%), survival to hospital admission (20.9% vs. 11.1%) and survival to hospital discharge (9.7% vs. 2.9%) than manual-CPR patients, and had no differences in neurological outcomes.
The ASPIRE findings surprised researchers, who'd seen positive indications from other clinical trials of the device.
"When you're in this business, you have to be prepared for this kind of thing, where a trial stops, and you have to figure out what you're going to do then," says Ward Hamilton, vice president of marketing for ZOLL Medical Corp., which manufactures the AutoPulse. "It's a complex area in which to do research, and this could be a major improvement. But clearly work needs to be done to continue to understand what the AutoPulse can do in terms of improving resuscitation."
The next step of that work could be a multicenter clinical study, planned to commence by the end of the year in the U.S. and Europe, to be led by noted Norwegian resuscitation expert Lars Wik, MD, PhD.
That could last several years. In the meantime, existing literature on the AutoPulse is available on ZOLL's website (www.zoll.com), and the company wants to be as open as possible about finding the safest and most appropriate ways to deploy the product.
"We're anxious to make sure people are fully aware of all this information," says Hamilton. "On balance, most of the research supports the benefits of uninterrupted, consistent compressions and using a load-distributing band-type product. Obviously, there are questions still to be answered, but if we weren't comfortable with the potential of the AutoPulse, we'd be hesitant to move ahead and put another trial together."
NAEMT MEMBERS STRONGLY BACK FEDERAL AGENCY
Talk of a lead federal EMS agency may have died down since 2005, but a vast majority of EMS providers responding to a survey by the NAEMT still feel such an agency is needed. In results released June 14, the NAEMT found that 95% of its estimated 3,000 survey participants believe a lead EMS agency at the federal level, similar to the U.S. Fire Administration, would benefit the delivery of EMS in America. As well, 92% feel EMS is not now represented adequately at that level of government.
"NAEMT members have spoken, and they recognize that the current situation is inadequate," the organization's president, Ken Bouvier, said of the results. "It's up to the politicians in Washington to do something about it, and we certainly hope that what they do results in more recognition and funding for EMS."
The polling showed less consensus about how EMS should be categorized. Of respondents, 93% agreed that EMS personnel are healthcare providers, 85% that they're public-safety responders, and 73% that they're public-health workers. Views were also mixed on the current Office of EMS in the National Highway Traffic Safety Administration (NHTSA) and the newly revamped Federal Interagency Committee on EMS (FICEMS). Fifty-five percent of respondents didn't know enough about the EMS Office's activities to gauge its effectiveness, and 59% didn't know enough about FICEMS.
The NAEMT emphasizes that given the unlikelihood of Congress creating a lead federal EMS agency in the immediate future, it fully supports both FICEMS and the current NHTSA Office of EMS.