September 26, 2018
The nearly 2 million Americans with severe heart failure face unique challenges.
Simple tasks such as short walks and climbing the stairs at home can lead to shortness of breath. Those with the condition often live in fear of heart attack or stroke.
Fortunately, there is a device that seems to offer promise in the management of severe heart failure in people for whom currently available treatments have been unsuccessful. Amazingly, the device, called the MitraClip, is similar in design to the clothespins you may use to hang your laundry to dry.
“The MitraClip is a small cardiac implant that can be opened and closed, and it is used to grasp the two leaflets of the mitral valve and bring them closer together, thereby reducing mitral regurgitation or leaking of the mitral valve,” explains Jason H. Rogers, MD, the director of interventional cardiology at the University of California Davis Medical Center in Sacramento. “The procedure [to insert the device] is done through a small catheter that is inserted into the right groin, and the recovery is rapid, with most patients being discharged home the following day.”
Half as Many Hospitalizations Observed in COAPT Study
Although the MitraClip still has to be approved by the U.S. Food and Drug Administration (FDA) for the treatment of secondary mitral regurgitation — or mitral valve leaking due to heart disease — the results of the most recent clinical trial of the device, which were released on September 23, appear promising.
Indeed, the findings of the so-called Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (COAPT) trial, published by the New England Journal of Medicine (NEJM), indicate that people in whom the device was used in combination with medical therapy as directed by currently accepted treatment guidelines required nearly half as many hospitalizations due to heart failure as those who received medical therapy alone.
In all, the COAPT trial enrolled 614 study subjects, 302 of whom were implanted with the MitraClip and 312 of whom continued medical therapy alone. Notably, 151 of the study participants in the medical therapy group were hospitalized for heart failure within two years of the start of the study, and 61 died. In comparison, only 92 of the participants in the MitraClip group were hospitalized over the same two-year period, and only 28 died.
An Earlier, Smaller Study Showed Higher Hospitalizations
As promising as these findings are for those with severe heart failure, though, it should be noted that not all of the studies of the MitraClip yielded the same results. Another, smaller trial, also published in NEJM, on August 27, found that hospitalizations due to heart failure increased among those who were implanted with the device.
Still, cardiologists like Dr. Rogers believe the MitraClip provides a promising new option for those with severe heart disease who may have few others. Rogers emphasizes that the MitraClip “works in conjunction with” existing and effective therapies and is not a “stand-alone” therapy for the condition.
“Until the results of the recent COAPT study were released, available options for patients with heart failure and a leaking mitral valve were limited to medications, pacemakers, and in some cases artificial heart pumps or heart transplant, which are highly invasive surgical therapies,” Rogers notes. “The MitraClip is a relatively straightforward and safe procedure that can have a profound benefit in properly selected patients by reducing death and hospitalization, and improving quality of life.”