A new device has been proven to treat severe heart failure — a breakthrough that could impact the care of almost 2 million Americans, the New York Times reported Sunday.
In research reported at a medical meeting in San Diego, Calif. — and published in the New England Journal of Medicine — a large clinical trial found that a small clip inserted into the heart reduced death rates in heart failure patients, and improved their quality of life.
“It’s a huge advance,” Dr. Howard Herrmann, the director of interventional cardiology at the University of Pennsylvania, which enrolled a few patients in the study, told the Times. “It shows we can treat and improve the outcomes of a disease in a way we never thought we could.”
If the device is approved by the Food and Drug Administration for treatment of severe heart failure, as expected, insurers, including Medicare, likely will cover it, the Times noted.
In heart failure, the organ becomes enlarged and tears apart the mitral valve, which then leaks and worsens the heart’s enlargement and function.
The study followed the use of a “MitraClip” device that repaired the mitral valve by clipping its two flaps together in the middle, enabling the valve to regulate blood flow in and out of the heart.
A trial of 614 patients with severe heart failure patients in the United States and Canada found that among those who received only medical treatment, 151 were hospitalized for heart failure over two years and 61 died.
Just 92 who got the device were hospitalized for heart failure during the period, and 28 died. Patients who had the minimally invasive procedure had 47 percent fewer heart failure-related hospitalizations and 38 percent fewer deaths.
“This is a game changer. This is massive,” said Mathew Williams, director of the heart valve program at NYU Langone Health, which had a few patients in the study.
“This will change how we treat these patients,” Williams told the Times. “Maybe we need to start intervening earlier.”
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