- The Washington Times - Monday, September 24, 2018

Patients suffering from a severe form of heart failure can benefit from a tiny implant that improves organ function and reduces hospitalization, according a study published Sunday in the New England Journal of Medicine.

The latest research, by surgeons from Columbia University, broadens the population base suffering from mitral regurgitation — a condition where a leaky valve allows blood to flow backwards — and uses a minimally invasive procedure and small clip to fix the defective valve.

The MitraClip was cleared by the Food and Drug Administration in 2013 as an accepted treatment for patients with mitral regurgitation who are at high risk for open-heart surgery — the standard of care for fixing this problem after failure of medication.

The U.S.-based pharmaceutical company Abbott developed the MitraClip and also provided funding for the Columbia University study.

Between 40 and 60 percent of patients with systolic heart failure — where the left ventricle of the heart has weakened — have mitral regurgitation, according to the Heart Failure Society of America.



Overtime, it causes shortness of breath, irregular heartbeats, enlargement of the heart and pain, according to Columbia University Department of Surgery.

The Columbia University surgeons enrolled more than 600 patients in the U.S. and Canada who had moderate to severe or severe mitral regurgitation.

The participants were randomized to an experimental group who received the MitraClip and a control group who continued on the standard of care treatment.

After the MitraClip was inserted into the hearts of the more than 300 patients — a minimally invasive procedure where doctors were able to apply the clip by going through the patients’ groin — only 35.8 percent experienced hospitalization due to heart failure in the subsequent two years.

The control group had a rate of hospitalization at 67.9 percent over the same time period.

Death from any cause over the two-year period occurred in the MitraClip group at a rate of 29.1 percent compared to 46.1 percent in the control group.

The researchers also wrote that among patients who received the clip, they had a better quality of life and functional capacity within two years of follow-up than medical therapy alone.

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