Three patients at NewYork-Presbyterian Hospital/Columbia University Medical Center were among the first in the U.S. 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 country 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 the risk of 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 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 U.S., while 500,000 to 800,000 patients have advanced heart failure. Many of those patients, though, don't 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, the 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 No. 1 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 partsincluding 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. Such features eliminate any bearings or contact points and allow the device to work at slower speeds, potentially reducing wear.
The DuraHeart trial ultimately will enroll 140 patients in up to 40 centers nationwide. The trial is designed for end-stage heart failure patients who 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 Corp., of Tokyo, Japan.
Columbia University Medical Center claims to be home to the largest medical research enterprise in New York City and state and one of the largest in the U.S.
NewYork-Presbyterian Hospital, based in New York City, claims to be the nation's largest not-for-profit, non-sectarian hospital, with 2,242 beds. The hospital has nearly 2 million inpatient and outpatient visits a year, including more than 230,000 visits to its emergency departments.
It provides 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.
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