Sharp Memorial Hospital has become the first hospital on the West Coast — and only the sixth in the country — to implant an investigational mechanical heart pump as part of a nationwide clinical trial. The trial is designed to evaluate the performance and safety of the device in patients with advanced heart failure.
A specialized medical team led by cardiovascular surgeon Robert Adamson, MD, successfully implanted the HeartMate III™ Left Ventricular Assist Device (LVAD) into Maria Valadez, 57, of San Diego, April 23. Valadez, a mother of four and grandmother of six, is one of only a few dozen people nationwide to have received the device so far.
Valadez, who has been married to her high school sweetheart for nearly four decades, said she began experiencing fatigue, shortness of breath and a cough several years ago. In March, she met with cardiovascular physicians affiliated with Sharp Memorial, who discovered that she was in advanced heart failure.
The HeartMate III™ Left Ventricular Assist System (LVAS) U.S. IDE Clinical Trial will involve up to 1,028 patients at about 60 hospitals. Patients who agree to participate in the study are randomly assigned to receive either the HeartMate III™ or the earlier-generation HeartMate II®. Both are manufactured by Thoratec Corp.
LVADs are designed to supplement the pumping function of hearts that are too weak to sufficiently pump on their own. One end of the device is attached to the left ventricle and the other is connected to the aorta, the main blood vessel that carries oxygen-rich blood from the heart into the body. Once blood flows from the left ventricle into the pump, a small electric motor drives a propeller that pushes the blood into the aorta and out to the body. The pump is connected to an external controller and two batteries via a tube that passes through the skin, called a driveline.
LVADs can be a short-term option for patients awaiting a heart transplant or a longer-term solution for patients unable to receive a transplant.
Sharp Memorial is San Diego’s leader in mechanical circulatory support devices such as LVADs. The hospital has implanted more than 500 LVADs into patients with heart failure since it became the region’s first hospital to use the device in 1987. More than 250 of those patients have received the HeartMate II®.
The hospital has advanced certification in ventricular assist devices from The Joint Commission, the leading accreditor of health care organizations in America. One of the hospital’s patients, who received an LVAD in 2002, is the world’s longest-living LVAD recipient.
This newest LVAD includes technology that allows the device’s rotor to be “suspended” by magnetic forces. Since the parts “float,” there is no friction and therefore less wear and tear on the rotor. This contact-free environment is designed to help minimize complications. In addition, its smaller size is intended to be easier and safer for surgeons to place. The pump also aims to be more patient-friendly by increasing the battery life to up to 17 hours, compared with the HeartMate II®, which needs to be recharged every 12 hours.
Nearly six million people in the United States suffer from congestive heart failure. Of these, more 250,000 are advanced cases.
For more information about heart care at Sharp Memorial Hospital, visit http://sharp.com/memorialheart.
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