BALTIMORE, May 6, 2011 /PRNewswire/ -- A new device designed to assist blood circulation and support blood pressure in high-risk patients undergoing percutaneous coronary intervention (PCI) has shown improved outcomes compared to the standard treatment with an intraaortic balloon pump. Results of the PROTECT II study were presented as a Late-Breaking Clinical Trial today at the SCAI 2011 Scientific Sessions in Baltimore.
These devices decrease the heart's workload and increase blood pressure by assisting the heart to pump blood, and are generally used in critical situations, such as after a heart attack. For many years physicians have used intraaortic balloon pumps to support the heart pumping blood. A new device called Impella 2.5 is small enough to be inserted like a catheter, through the groin, to the heart's main pumping chamber to assist the heart in pumping blood.
"As PCI advances, we're increasingly able to treat sicker patients, but often those patients have great strains on their hearts and need extra blood pressure support. The Impella device is small enough to be inserted directly into the heart to assist the heart in pumping blood to the rest of the body," said William O'Neill, M.D., FSCAI, executive dean of clinical affairs at the University of Miami and the study's principal investigator. "Our study compares this new device to standard pumping devices used for high-risk patients."
Researchers enrolled 447 of a planned 654 patients between November 2007 and November 2010 who required blood pressure support. Patients included those with severe coronary artery disease and decreased heart pumping capacity. Researchers measured the number of major adverse events (MAE) at 30 days.
The study was halted after review of data on the first 50 percent of patients suggested no benefit would occur. After the study was halted and the entire population was followed for 90 days, investigators found that results improved over the c
|SOURCE Society for Cardiovascular Angiography and Interventions (SCAI)|
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