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Update for Valve Repair Device Intended to Lower Mitral Regurgitation Rates

By Jonathan Springston, Editor, Relias Media

The FDA has approved a new indication for a heart valve repair device designed to reduce episodes of mitral regurgitation, when blood leaks backward through the mitral valve into the left atrium of the heart.

Since its approval in 2013, the MitraClip has been indicated for patients with moderate-to-severe or severe mitral regurgitation. Now, a new indication expands the eligible patient pool to include those with normal mitral valves who develop heart failure symptoms and moderate-to-severe or severe mitral regurgitation because of diminished left heart function despite using optimal medical therapy.

“Expanding the approval of this device to heart failure patients with significant secondary mitral regurgitation, who have failed to get symptom relief from other therapies, provides an important new treatment option,” Bram D. Zuckerman, MD, director of the division of cardiovascular devices in the Center for Devices and Radiological Health, said in a statement. “Careful evaluation by a team of specialists is essential to determining whether a particular patient is an appropriate candidate for this procedure.”

In the November 2018 issue of Clinical Cardiology Alert, Jeffrey Zimmet, MD, wrote extensively about the study on which the FDA based its decision to approve the new indication for the MitraClip.

Mitral regurgitation has been a frequent subject of discussion in the pages of Clinical Cardiology Alert. In the upcoming April 2019 issue, Editor Michael Crawford, MD, writes about a large observational study of patients with severe mitral valve regurgitation due to flail leaflets that revealed that atrial fibrillation at entry was associated with excess mortality. Surgery to correct regurgitation was associated with better survival vs. medical therapy; however, atrial fibrillation negatively influenced post-surgical outcomes.

“Mitral valve surgery for severe DMR [degenerative mitral regurgitation] with new onset AF [atrial fibrillation] is a class IIa-B recommendation if repair at a low risk is highly feasible. The lack of data has kept AF from attaining a class I indication,” Crawford observes. The results of this study suggest that a class I indication may be warranted now in patients with severe DMR due to a flail leaflet who develop AF.”

For more on this subject and other cardiology-related news and research, be sure to check out the latest from Clinical Cardiology Alert here.