Three patients at NewYork-Presbyterian Hospital/Columbia University Medical Center were among the first in the United States to be implanted with a next-generation artificial heart pump called the DuraHeart™ Left-Ventricular Assist System. The surgeries took place earlier this year. NewYork-Presbyterian/Columbia is one of only three centers in the U.S. currently enrolling patients in a clinical trial studying the device.
The DuraHeart is designed to sustain patients with severe left-ventricular heart failure while they wait for a heart transplant. Without intervention, they are at risk of death.
The surgeries were led by Dr. Yoshifumi Naka, director of cardiac transplantation at NewYork-Presbyterian Hospital/Columbia University Medical Center and associate professor of surgery at Columbia University College of Physicians and Surgeons. He elected to implant the device without stopping the heart and putting the patient on a heart-lung machine. This "off pump" approach reduces risk for bleeding and stroke associated with putting a patient on bypass.
"In this clinical trial, we hope to show that this device can help patients retain a healthy and meaningful quality of life while awaiting a heart transplant," says Dr. Naka, one of three national co-principal investigators of the DuraHeart trial. "Eventually, the DuraHeart may also prove to be a long-term solution, even for those ineligible for transplantation."
There are fewer than 2,500 hearts transplanted each year in the United States, while 500,000 to 800,000 patients have advanced heart failure; many do not qualify for transplantation due to other health issues. The average wait for a transplant is nine months due to a shortage of donor organs.
In patients with advanced heart failure, their heart isn't strong enough to pump sufficient blood for normal activities, leaving them greatly fatigued and frequently bedridden with difficulty breathing; heart failure is the number one reason for hospitalization. Mechanical heart pumps like the DuraHeart are designed to help the heart pump blood from the left ventricle to the aorta, increasing flow throughout the body. Previous research has shown the approach can help alleviate symptoms and improve survival.
The first left-ventricular assist device, or LVAD, became available in the mid-1980s. Since then, the technology has improved, becoming more compact and with fewer moving parts -- including through clinical research at NewYork-Presbyterian/Columbia leading to the FDA approval of Thoratec's HeartMate® and HeartMate® II. The DuraHeart is considered a third-generation device, with unique features -- including a paddlewheel-like component called an impeller that is suspended by an electromagnet -- eliminating any bearings or contact points and allowing it to work at slower speeds, potentially reducing device wear and risk for blood cell breakage.
The DuraHeart Trial will ultimately enroll 140 patients in up to 40 centers nationwide. The trial is designed for end-stage heart failure patients that have been placed on a heart transplant list in the U.S.
The trial is sponsored by Terumo Heart Inc. of Ann Arbor, Mich., maker of the DuraHeart System and a wholly owned subsidiary of Terumo Corporation of Tokyo, Japan.
For more information, patients may call (866) NYP-NEWS.
Columbia University Medical Center
Columbia University Medical Center provides international leadership in basic, pre-clinical and clinical research, in medical and health sciences education, and in patient care. The Medical Center trains future leaders and includes the dedicated work of many physicians, scientists, public health professionals, dentists, and nurses at the College of Physicians & Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. Established in 1767, Columbia's College of Physicians and Surgeons was the first institution in the country to grant the M.D. degree and is now among the most selective medical schools in the country. Columbia University Medical Center is home to the largest medical research enterprise in New York City and state and one of the largest in the United States. For more information, please visit www.cumc.columbia.edu.
NewYork-Presbyterian Hospital, based in New York City, is the nation's largest not-for-profit, non-sectarian hospital, with 2,242 beds. The Hospital has nearly 2 million inpatient and outpatient visits in a year, including more than 230,000 visits to its emergency departments -- more than any other area hospital. NewYork-Presbyterian provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine at five major centers: NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian Hospital/Columbia University Medical Center, NewYork-Presbyterian Morgan Stanley Children's Hospital, NewYork-Presbyterian Hospital/The Allen Pavilion and NewYork-Presbyterian Hospital/Westchester Division. One of the largest and most comprehensive health care institutions in the world, the Hospital is committed to excellence in patient care, research, education and community service. NewYork-Presbyterian is the #1 hospital in the New York metropolitan area and is consistently ranked among the best academic medical institutions in the nation, according to U.S.News & World Report. The Hospital has academic affiliations with two of the nation's leading medical colleges: Weill Cornell Medical College and Columbia University College of Physicians and Surgeons. For more information, visit www.nyp.org.Office of Public Affairs
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