New Device to Support Blood Circulation for Heart Patients Shows Improved Outcomes Compared to Current Treatment

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 course of the study, suggesting that there is a learning curve for physicians using the device.

At 30 days, results show there was no difference in MAE among the 447 patients randomized to treatment with Impella or intraatortic balloon pump. After 90 days there was a trend that did not reach significance toward improved outcomes for patients treated with Impella. Subgroup analysis showed the clinical benefit was more pronounced for patients undergoing high-risk PCI without atherectomy with the Impella support. Further cost analysis found treatment costs after 90 days for patients in the Impella group were $14,000 lower than for those treated with intraaortic balloon pump.

Dr. O'Neill reports no conflicts of interest.

Dr. O'Neill will present "A Prospective Multicenter Randomized Clinical Trial of Intraaortic Balloon Pump vs. Impella for Hemodynamic Support During High-Risk PCI: 90-Day Results from PROTECT II" in the General Session on Friday, May 6, 2011, from 12:00 p.m. to 12:15 p.m.

About SCAI

Headquartered in Washington, D.C., the Society for Cardiovascular Angiography and Interventions is a 4,000-member professional organization representing invasive and interventional cardiologists in approximately 70 nations. SCAI's mission is to promote excellence in invasive and interventional cardiovascular medicine through physician education and representation, and advancement of quality standards to enhance patient care. SCAI's annual meeting has become the leading venue for education, discussion, and debate about the latest developments in this dynamic medical specialty. SCAI's patient and physician education program, Seconds Count, offers comprehensive information about cardiovascular disease. For more information about SCAI and Seconds Count, visit www.scai.org or www.SecondsCount.org.

SOURCE Society for Cardiovascular Angiography and Interventions (SCAI)