An experimental device that enables doctors to repair the heart’s mitral valve without open-heart surgery has proved successful in a preliminary study, researchers report.
Degenerative mitral regurgitation, which is the most common form of heart valve disorder, affects about two percent of the population, or eight million people. The condition occurs when the mitral valve, which is one of the four valves that keeps the blood flowing through the heart correctly, becomes leaky. Because of this, a portion of blood travels in the wrong direction, resulting in shortness of breath, fluid retention, irregular heartbeats and fatigue.
In severe cases, surgical repair of the heart’s mitral valve may be recommended. This requires open-heart surgery during which the patient’s heartbeat is stopped, and the patient is maintained on a heart-lung machine. This procedure carries significant risk and a lengthy recuperation period is also required.
But now researchers at the University of Maryland’s School of Medicine are testing a novel device that repairs the mitral valve less invasively and can also be performed while the heart continues to beat.
The mitral valve is connected to the heart with small fibrous cords that open and close the valve’s flaps, which are known as leaflets. The natural cords connect the valve flaps to muscles inside the heart that contract to close the mitral valve. When the valve is diseased, though, the leaflets become broken or stretched.
The new device, known as the Harpoon TDS-5, anchors artificial cords on the flaps to take the place of the mitral valve's natural cords. The artificial cords are made of expanded polymer commonly used as sutures in cardiac surgery. The device is inserted into the patient’s heart beating heart through a tiny hole in the ribcage and guided into place using electrocardiographic imaging.
The device was tested on 11 patients at two clinical centers in Poland. Patients were stable after 30 days and the procedure is safe, the investigators said of the study, which was reported in Circulation.
“We think this is a safer approach than open heart surgery,” says principal investigator Dr. James S. Gammie, the school’s chief of cardiac surgery. “We think the safety profile is going to be better and, ultimately, people will be able to go home from the hospital the next day.”
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