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Clamp Device for Leaky Heart Valve Seems Effective

Small study suggests MitraClip may help some with mitral regurgitation avoid open-heart surgery

MONDAY, April 4, 2011 (HealthDay News) -- A minimally invasive treatment for mitral regurgitation -- a leaky heart valve condition common among seniors -- appears to be as effective as open-heart surgery, new research suggests.

While both interventions take about two hours to perform, the newer alternative to open-heart surgery tackles mitral regurgitation by means of a catheter-enabled insertion of a tiny clothespin-like device, called a "MitraClip," which is threaded through a major artery into the heart to clamp the leak.

Both methods achieve roughly the same degree of symptom relief, the study found. But the MitraClip approach seems to get the job done while requiring far less hospitalization and recovery time.

"After getting a MitraClip, patients spend one or two nights in the hospital versus five to seven days after open-heart surgery, and they're back to full activity immediately," study co-author Dr. Ted Feldman, director of the cardiac catheterization laboratory at NorthShore University HealthSystem in Evanston, Ill., said in a news release from the American College of Cardiology. "Traditional open-heart surgery has a recovery time of one to three months. The contrast is pretty striking."

Feldman and his colleagues are slated to present their findings Monday at the American College of Cardiology meeting, in New Orleans. Experts note that research presented at meetings isn't subjected to the same type of scrutiny given to research published in peer-reviewed journals.

The study was funded by Evalve Inc., the maker of the MitraClip.

The authors noted that among those aged 55 and up, one in five have clinical indications of mitral regurgitation, which results when the mitral valve in the heart stops closing properly, permitting blood to leak back into the heart, and causing the heart to pump hard as a result. Symptoms included breathing difficulty, fatigue, dizziness, foot and leg swelling, coughing and/or palpitations.

Yet among the quarter-million Americans who are diagnosed each year with the condition, only one-fifth actually undergo open-heart surgery to repair or replace the valve due to a general reluctance to submit to such an invasive and risky procedure.

As a consequence, many patients turn to medications for symptom relief as their ability to engage in routine physical activity progressively diminishes.

The MitraClip procedure involves the guidance of a tiny clip (or sometimes two clips) through the groin and femoral artery into the heart, where the valve is correctively clamped.

The current study involved 279 patients being treated for mitral regurgitation in 37 different health care facilities across North America.

After randomly assigning patients to one or the other intervention, the investigators found that while nearly 63 percent of the MitraClip group performed well in terms of survival, symptoms and need for further treatment, that figure was only slightly higher (about 66 percent) among the open-heart surgery group.

They further noted that among the MitraClip patients, 78 percent did not need additional surgery in the two years following their initial procedure.

What's more, far fewer of the MitraClip patients experienced side effects (such as the need for subsequent blood transfusions) compared with the open-heart group (15 vs. nearly 48 percent).

The team noted that while a replacement heart valve lasts for 35 years, a MitraClip valve repair will endure for about 15 years. And patients undergoing the former must take the blood-thinning drug warfarin for life, but clip patients only have to follow a one-month regimen of the drug clopidogrel, followed by a six months of aspirin.

Feldman and his team concluded that while further long-range evaluation is needed, the clip method appears to be a viable option for some mitral regurgitation patients.

Dr. James Slater, director of the cardiac catheterization laboratory at NYU Langone Medical Center, tested the MitraClip in a clinical trial and had this to say: "In my opinion, the MitraClip is a major advance in the treatment of mitral regurgitation for some patients. Although the degree of reduction in valve leaking is not as great with the MitraClip as it is with conventional valve surgery, MitraClip patients have similar improvements in their symptoms, and at two years 78 percent did not require conversion to surgery."

Slater added, "For older patients especially, the MitraClip technology frequently offers the same gain, but with much less pain."

More information

For more on mitral regurgitation, visit the U.S. National Library of Medicine.

SOURCES: American College of Cardiology, news release, April 4, 2011; James Slater, M.D., director, cardiac catheterization laboratory, NYU Langone Medical Center, New York City
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