FDA Approved Heart Assist Pump for Permanent Implantation
According to the American Heart Association, 4.8 million Americans have ]]>congestive heart failure]]> (CHF), a condition in which the heart is unable to pump the necessary amount of blood throughout the body. Congestive heart failure is a major chronic condition in the United States, marked by increasing prevalence, hospitalizations, and deaths.
One type of CHF, called left-sided failure, is caused by a progressive failure of the left ventricle—the large, muscular chamber of the heart that pumps oxygen-rich blood out of the heart to the rest of the body. This form of CHF is often treated with medications and/or surgery, including a heart transplant. Patients may have another option.
A heart assist pump, approved by the US Food and Drug Administration (FDA), be permanently implanted in people with CHF who are too old or too ill to qualify for a heart transplant. HeartMate is a left ventricular assist device (LVAD) that takes over the work of the left ventricle. HeartMate II, a more compact device for smaller adults, is also FDA approved.
How Does a LVAD Work?
An LVAD has two tubes attached to an electric pump. The pump is placed in the upper abdomen. One tube goes into the left ventricle and pulls blood from the ventricle into the pump. The pump then sends blood into the aorta (the large blood vessel leaving the heart), thereby doing the work the weakened ventricle can no longer do. The pump's other tube is directed through the wall of the abdomen to the outside of the body where it is attached to the pump's control system.
Study Produces Impressive Results
According to the US Food and Drug Administration, a randomized clinical trial was conducted on 129 people with end-stage CHF. Sixty-eight received the HeartMate and 61 continued to receive the best drug treatment available. The study showed that treatment with HeartMate doubled survival rates at one year compared to drug treatment—at one year, the survival rate was 50% for those on HeartMate, compared to 28% for those receiving drug treatments. After two years, estimated survival for those on HeartMate was 27%, compared to 10% for those on drug therapy.
Potential Problems with the Device
Although HeartMate increases survival, implanting the device requires major surgery—on people who are already seriously ill. Problems seen in the clinical trial with HeartMate included bleeding that required additional surgery (32%), infection (41%), and stroke (10%). As a result of these serious side effects and the small population in which it was studied, HeartMate will be limited to certain very sick patients with severe end-stage CHF who are not eligible for a heart transplant—an estimated 20,000 to 30,000 people in the United States.
LVADs Offer a Promising Solution
According to the Scientific Registry of Transplant Recipients, a total of 2,202 heart transplants were performed during 2001, but 623 people on the waiting list died and 139 people deteriorated to the point where they were ineligible for a transplant during that time. Not all of the people who received heart transplants had CHF, but a majority did have heart conditions that would eventually lead to CHF. By the end of 2001, 4,097 people were still waiting for a heart transplant.
LVADs can offer a promising solution for many patients. As the technology improves, more people will be able to receive the device.
American Heart Association
Food and Drug Administration
Heart and Stroke Foundation of Canada
University of Ottawa Heart Institute
1/22/2010 DynaMed's Systematic Literature Surveillance DynaMed's Systematic Literature Surveillance: FDA approves first compact heart assist device. US Food and Drug Administration website. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116881.htm. Published April 21, 2008. Accessed January 22, 2010.
Last reviewed January 2009 by ]]>Igor Puzanov, MD ]]>
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