Severe heart failure affects more than 2 million people in the United States, making even simple tasks—climbing stairs, taking a walk—extremely difficult. Medications can help ease symptoms but they don’t alter the course of this fatal disease.

However, the Food and Drug Administration (FDA) recently approved the use of a small device to treat severe heart failure in people with a leaky mitral valve. As a result, the typically grim prognosis for many of these people may change. Though the device, called MitraClip, has been around for a while, it was only approved to treat people who had leaky heart valves but did not have heart failure.

The FDA approved this new application after researchers from Washington University and other institutions completed a clinical trial called COAPT (Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy for High Surgical Risk Patients Trial). The study showed the risk of death in the two years following insertion of the device was 37%, lower than it was for people treated with medication alone.

The MitraClip works by clipping together the leaflets, or flaps, of the heart’s mitral valve at the point where blood leakage occurs, essentially acting as a gatekeeper that prevents blood from flowing backward through the faulty valve. And a surgeon can put the clip in place without open surgery. During the procedure, the patient receives general anesthesia, then a surgeon inserts a catheter into a vein in the groin and threads it up to the heart. Using ultrasound for guidance, the surgeon places the catheter into the left atrium, where it delivers and places the MitraClip. The average hospital stay after the procedure is one to two days.

[MITRACLIP] CAN ALTER PEOPLES’ SYMPTOMS AND GREATLY IMPROVE QUALITY OF LIFE.

People with severe heart failure may be eligible for the MitraClip intervention if surgery to replace the mitral valve is too risky, and they have received all appropriate standard therapies and medications. When Justin Vader, MD, MPHS, a Washington University cardiologist at Barnes-Jewish Hospital, and a multidisciplinary team of specialists in heart failure and cardiac surgery assess a patient’s ability to undergo the procedure, Vader says they are looking for just the right conditions, a “Goldilocks zone” that serves as a strong indicator of a good outcome.

Alan Zajarias, MD, a Washington University interventional cardiologist at Barnes-Jewish Hospital and the co-director of the Center for Valvular Heart Disease, says this new application for MitraClip has the potential to change lives “For some people, it is a game-changer,” he adds. Vader agrees: “We have evidence that MitraClip improves survival. It can alter peoples’ symptoms and greatly improve quality of life.”