A device called the MitraClip may introduce a life-saving new procedure for patients suffering from severe and difficult-to-treat heart failure, according to a promising new study.
The device reduced hospitalizations related to heart failure by nearly half, and deaths by nearly 40 percent, among patients with secondary mitral regurgitation (MR) — compared to those who received standard medical treatment. The results were published Sunday in the New England Journal of Medicine .
The rates of re-hospitalizations and deaths dropped for patients who had a MitraClip heart device made by Abbott Laboratories implanted, according to researchers at a recent medical conference in San Diego. Abbott’s “Coapt” trial, which included patients in multiple hospitals, was described as giving doctors a long-sought method of treating secondary MR.
The study involved 614 patients with secondary (MR). These patients’ mitral valves leaked, causing blood to back up into the heart and forcing the organ to work harder to circulate blood throughout the body. The mitral valve is one of four valves in the heart. It opens and closes to control blood flow between the heart’s left atrium and the left ventricle.
“This is the most positive study that we have seen in years in which an interventional procedure can improve symptoms, quality of life and survival,” said Ramon Quesada, M.D. , medical director of the Structural Heart and Complex Percutaneous Coronary Intervention Programs at Miami Cardiac & Vascular Institute  at Baptist Hospital. “These patients are very sick.”
Dr. Quesada and the Institute have been at the forefront of MitraClip procedures for several years. Interventional cardiologists implant the MitraClip into patients by making a puncture in the skin of the groin and threading a catheter with the clip up to the heart valve through a vein in the leg. The clip grasps the two leaflets that make up the valve and helps them close.
In 2013, the U.S. Food and Drug Administration (FDA) approved the MitraClip to repair mitral valve prolapse, and other abnormalities of the mitral valve apparatus that do not allow the heart’s mitral valve to close properly. During the trial that lead to that FDA approval, Dr. Quesada implanted nearly 50 of these devices in patients with good outcomes. He was the only doctor in Florida chosen to implant the device to test its effectiveness.
The FDA now is expected to approve the MitraClip for patients with secondary MR, based on the very encouraging results of the new study.
“I’ve been doing these types of procedures since 2006,” says Dr. Quesada, who is on the medical advisory board for Abbott Laboratories and trains other interventional cardiologists on MitraClip procedures. “Most likely the FDA will approve this procedure for this group of patients. The results are so compelling, that I think has very good chance to be approved for this indication.”