A new nationwide study published in the New England Journal of Medicine that included researchers from the Intermountain Medical Center Heart Institute in Salt Lake City found that a tiny clip placed in the heart to fix a leaky mitral valve drastically decreases the risk of both dying and returning to the hospital for heart failure patients.
The study found that the MitraClip device reduced risk of hospitalization by half and deaths by nearly 40 percent, as well as significantly improving the quality of life for patients with secondary mitral regurgitation – a deformity of the mitral valve in the heart caused by heart failure – who usually have a poor prognosis.
Doctors says results from the study are profound for patients with heart failure.
“I expected it to be positive, but we were all surprised at how amazingly positive it is,” said the study’s co-author, Brian Whisenant, MD, an interventional cardiologist at the Intermountain Medical Center Heart Institute.
The Intermountain Medical Center Heart Institute was the fourth-leading enroller of patients in the study, which included 78 participating centers in the United States and Canada.
Of the 614 heart failure patients with secondary mitral regurgitation who were enrolled in the study, 302 received the MitraClip, a tiny device that is attached to the mitral valve to repair the leaking valve.
In patients with this condition, the mitral valve has been deformed by heart failure, which leads to leaks that make the heart work harder to move blood through the body. Unlike surgery, the MitraClip procedure does not require opening the chest surgically and temporarily stopping the heart.
Instead, interventional cardiologists access the mitral valve through a catheter that is guided through a vein in the groin to the heart. It’s then maneuvered so the MitraClip is right above the malfunctioning mitral valve. With ultrasound guidance, the clip is positioned so it can grab the two leaflets of the valve and pull them together. Once that happens, the sides of the valve will once again open and close normally.
Among patients who received the MitraClip, researchers found that two-year hospitalization rates for those patients was reduced from 67.9 percent (without the device) to 35.8 percent (with the device), and deaths were reduced from 46.1 percent (without the device) compared to 29.1 percent (with the device).
About half of people who develop heart failure die within five years of diagnosis, according to the American Heart Association.
For those with secondary mitral regurgitation, blood doesn’t flow properly though their bodies, which can plummet their quality of life, said Dr. Whisenant.
“They’re typically short of breath and profoundly fatigued.” he added.
Currently, the MitraClip is approved by the U.S. Food and Drug Administration for patients with primary mitral regulation who are too frail for open heart surgery. Dr. Whisenant anticipates that results from the study will lead to the FDA approving the device for patients with secondary mitral regurgitation, as well.
The results of the study are part of a long-running study, “Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation” (COAPT). Researchers from the Intermountain Medical Center Heart Institute, part of the Intermountain Healthcare system based in Salt Lake City, have been investigating the MitraClip device since 2007.
Dr. Whisenant said the extensive study relied on multidisciplinary expertise from heart failure cardiologists, cardiovascular surgeons, imaging cardiologists, and interventional cardiologists.
“This is a long, complicated study. Intermountain Healthcare’s long-term involvement speaks to our commitment to cardiac research, and Intermountain Healthcare's commitment to providing each unique patient with the most appropriate care” said Dr. Whisenant. “It will change the world of heart failure and mitral valve regurgitation.”
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New England Journal of Medicine, Oct-2018