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Continuous Flow Cardiac Pump Marks Major Advance
August 28, 2007 |
Contact: Paula Faria
202-877-7594
paula.faria@Medstar.net
Offers An Option for Those Awaiting Transplant
Washington, DC August 30, 2007 A groundbreaking national heart failure study headed by Washington Hospital Center�s Director of Cardiology, Leslie W. Miller, MD, and published in today�s issue of The New England Journal of Medicine gives new hope to those in advanced stages of heart failure.
The study followed 133 heart failure patients listed for heart transplant who underwent surgery to implant a new type of investigational, miniaturized mechanical circulatory assist device. The new heart pump is implanted alongside a patient�s own heart and is designed to take over the pumping ability of the weakened heart�s left ventricle by circulating oxygenated blood throughout the body. It uses a single rotating part to pump up to 10 liters of blood per minute, the normal output of a healthy heart. Its purpose is to provide long-term cardiac support for patients with advanced-stage heart failure.
The study sought to determine the safety and effectiveness of these continuous flow heart pumps as a �bridge� device to improve heart function while patients await heart transplantation. The results were clear and better than the projected outcomes. One hundred patients (75%) survived to six months, 68% to one year with the cardiac assist device. Many patients noticed a significant improvement at three months in the ability to resume usual activities and their quality of life. In fact, four patients were so pleased with their lives on the pump, they removed themselves from the transplant list, choosing to stay with the pump.
Dr. Miller, principal investigator of the national study, characterized the findings as perhaps the most important advance in his 25-year career as a heart failure cardiologist and researcher. It�s important for physicians and the general public to know that these patients have not only survived from a high risk of dying or refractory heart failure, but are very active and robust and have a tremendous quality of life,� Miller said. We are confident that probably within the next five years, the outcomes with this technology will equal those with heart transplantation and provide an excellent alternative to those not eligible for transplant largely because of age.�
These heart pumps are lighter and much smaller than the device currently approved by the Food and Drug Administration. This means it can implanted in individuals with small body frames, including many women and even adolescents who were previously without an option for this type of support due to the large size of previous devices. Unlike other left ventricular assist devices (LVADS) that use a pulsatile, or fill and empty, design, the pump used in the study is an axial flow device, which pumps continuously so there is no pulse and significantly less noise. More importantly, this new generation pump, with only one moving part, is devised to be more durable and to last longer than current LVADs of different design. Some estimates predict the pump could last from five to 10 years.
The results of a parallel trial of this pump, in patients not eligible for heart transplantation, as so-called �destination therapy� should be available in one year. That study will examine the anticipated enhanced durability and outcomes in this population which is the largest patient group with advanced heart failure.
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Last updated: 07-26-2007
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