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
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